Medical devices, 2015: every recall, from FDA

Medical device recall SMARTABLATE RF Generator System Biosense Webster is recalling the SMARTABLATE Generator System because Biosense Webster has received two complaints reporting that during an RMT procedure the… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Kentucky, New Jersey and Pennsylvania named

Medical device recall Philips Healthcare DigitalDiagnost System X-Ray The system is designed to emit a beep upon termination of an exposure. Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Philips Healthcare DuraDiagnost X- Ray The system is designed to emit a beep upon termination of an exposure. Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086 Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and… Integra LifeSciences Corporation is recalling Integra’s Camino ICP Monitor (CAM02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible… Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and… Integra LifeSciences Corporation is recalling Integra’s Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible… Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software The MYLA¿ server could slow down due to the volume (weight) of the data to manage and it could also stop processing, impacting the server start-up phase. Class IIFDA’s classMay 27, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereGeorgia and Guam

Medical device recall Homocysteine test system - Homocysteine Reagent. 05385415190 Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named

Medical device recall CT LightSpeed 16 and Discovery ST Pet/CT DST GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain Lightspeed 16 CT scanner… Class IIFDA’s classMay 27, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereFlorida, Minnesota and Texas

Medical device recall PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED The term DORSAL was laser etched on the incorrect side on some of the angled handles. Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED The term DORSAL was laser etched on the incorrect side on some of the angled handles. Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED The term DORSAL was laser etched on the incorrect side on some of the angled handles. Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED The term DORSAL was laser etched on the incorrect side on some of the angled handles. Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS… Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possibility that the compounder will load the incorrect formula upon… Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall IMMULITE/IMMULITE 1000 Systems TBG IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of <1.80. Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Carter-Thomason II Port Closure System The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have been appropriately manufactured resulting in the pad… Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option When EPIQ 5 Ultrasound System, WITHOUT the Pediatric Cardiology option, is set up to “Metric” and weight and/or height is entered, a unit conversion error may… Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option When EPIQ 7 Ultrasound System, WITHOUT the Pediatric Cardiology option, is set up to “Metric” and weight and/or height is entered, a unit conversion error may… Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Stryker Howmedica Osteonics RESTORATION Acetabular Augment System The peel strength of the inner blister may have been below internal validated requirements. Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall Stryker Orthopaedics Scorpio femoral component The peel strength of the inner blister may have been below internal validated requirements. Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall Stryker Orthopaedics Triathlon femoral component The peel strength of the inner blister may have been below internal validated requirements. Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall MelaFind Device The probability and histogram data within the Melafind’s device displayed user interface lacks approval (not included in the PMA supplement). Class IIFDA’s classMay 27, 2015in FDA’s Enforcement Report21 statesnamed in where it went PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Connecticut, Florida, Hawaii, Illinois, Massachusetts, Maryland, Michigan, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia and Washington

Medical device recall Mucolytic Agent 1 pint/473 ml Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal… Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named

Medical device recall Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal… Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named

Medical device recall ENDOPATH ECHELON” Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have… During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line. Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named

Medical device recall DeRoyal(R) Medium Specimen Retrieval Bag The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use. Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Pinnacle3 Software Version 10.0 A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in the Philips Pinnacle3 software version 10.0 that, if it were to… Class IIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 27, 2015ClassClass IIStatusTerminatedWhereNationwide, and Florida, Missouri and Ohio named

Medical device recall ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17 Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly. Class IIIFDA’s classMay 20, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 20, 2015ClassClass IIIStatusTerminatedWhereCalifornia and North Carolina

Medical device recall Spinal Elements 5.5 x 45MM Mercury lordosed rod Some rods may not meet the appropriate traceability requirements including the lot number. Class IIIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMay 20, 2015ClassClass IIIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Indiana, Michigan, Missouri, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Utah named

Medical device recall Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical… During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named

Medical device recall VenaSeal, Sapheon Closure System Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray. Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall TFN-ADVANCED Proximal Femoral Nailing System (TFNA) TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Vitek 2 AST-YS06 The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258 Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Vitek 2 AST-YS07 The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258 Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Vitek 2 AST-YS01 The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258. Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the… Failures of the splice repair kit if exposed to excessive force. FDA Class I, its most serious class Class IFDA’s classMay 20, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 20, 2015ClassClass IStatusOngoingWhereNationwide, and Florida, Kentucky, Missouri, New York, Tennessee and Texas named

Medical device recall Tapered HD Upgrade Set BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Louisiana, Maryland, Mississippi, North Carolina, New York, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont and Washington named

Medical device recall GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50). The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereColorado, Michigan and Wisconsin

Medical device recall Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma… The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned. Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall Spacelabs qube Compact Monitor The input power can fail even though the power source at the wall has not been interrupted. Class IIFDA’s classMay 20, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNorth Carolina, Texas and Wyoming

Medical device recall Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10 Devices were placed in a shipper carton without the appropriate number of the Instructions for Use (IFU). Class IIIFDA’s classMay 20, 2015in FDA’s Enforcement Report8 statesnamed in where it went PublishedMay 20, 2015ClassClass IIIStatusTerminatedWhereArizona, California, Idaho, Illinois, Maryland, North Carolina, Rhode Island and South Carolina

Medical device recall FujiMedical Synapse Cardiovascular I ProSolv CardioVascular Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report. Class IIFDA’s classMay 20, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Texas, Virginia and Wisconsin

Medical device recall Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular… Under certain circumstances the patient Demographics in a report exported into the EMR may not match the demographics shown in the corresponding Synapse CV… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Illinois, Indiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Oregon, Pennsylvania and Puerto Rico named

Medical device recall ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch Complaints were received that the heat-welded seam on the wipeable belt’s strap tore when force was applied. Class IIFDA’s classMay 20, 2015in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maryland, North Carolina and New Jersey

Medical device recall Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed… Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 (Kinemax Stem Extenders, 80 mm) there was a different part… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts and Rhode Island named

Medical device recall Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL… Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been installed with a non-standard instrument power plug.The use of a… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall COULTER DxH Diluent Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWherePuerto Rico

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