Medical devices, 2017: every recall, from FDA

Medical device recall AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1”… Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and Florida, Massachusetts, Michigan, Missouri, New Mexico, Oklahoma, Virginia and Washington named

Medical device recall LX3 Floor Stand for LuxOR Ophthalmic Microscope Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope may stress the microscope base, which could contribute to a caster breaking or… Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall CIVCO Arm Support Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521,… Class IIFDA’s classSep 6, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereIllinois, Michigan and Texas

Medical device recall Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched… The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. Class IIIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedSep 6, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Arizona, Illinois, Indiana, Kentucky, Nevada, Pennsylvania, Tennessee and Texas named

Medical device recall Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of… Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar) The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures. Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2 The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation. Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named

Medical device recall MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Class IIFDA’s classSep 6, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereOhio and Virginia

Medical device recall Convertors Robotic Drape with Attached Leggings Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement Report8 statesnamed in where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereFlorida, Georgia, North Carolina, New Jersey, New York, Oregon, Texas and Utah

Medical device recall VASER Amplifier, VASER 2.2 VASERlipo System Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, New York, Pennsylvania and Texas

Medical device recall VASER PRO Amplifier, VASER 2.2 VASERlipo System stem Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, New York, Pennsylvania and Texas

Medical device recall ORA System with VerifEye+ Cart Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall ORA System with VerifEye Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Medtronic Straight Suction 9733449 EM ENT, reusable, Rx The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Various custom surgical kits The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide” 22GA 1¿ inch Needles. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Kansas, New Jersey, New York, Ohio and Tennessee named

Medical device recall Tissu-Trans Filtron 100, 3-TT-FILTRON 100 Seal integrity of the Tissu-Trans product sterile packages cannot be assured. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named

Medical device recall Tissu-Trans Filtron 250, 3-TT-FILTRON 250 Seal integrity of the Tissu-Trans product sterile packages cannot be assured. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named

Medical device recall Tissu-Trans Filtron 500, 3-TT-FILTRON 500 Seal integrity of the Tissu-Trans product sterile packages cannot be assured. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named

Medical device recall Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000 Seal integrity of the Tissu-Trans product sterile packages cannot be assured. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named

Medical device recall Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000 Seal integrity of the Tissu-Trans product sterile packages cannot be assured. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named

Medical device recall Tissu-Trans MEGA 1500, 3-TT-MEGA 1500 Seal integrity of the Tissu-Trans product sterile packages cannot be assured. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named

Medical device recall Tissu-Trans SFILL 360, 3-TT-SFILL 360 Seal integrity of the Tissu-Trans product sterile packages cannot be assured. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named

Medical device recall Ultrasound Video Gastroscope Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S,… Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which can result in DBS lead placement beyond the intended target. Class IIFDA’s classAug 30, 2017in FDA’s Enforcement Report47 statesnamed in where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia

Medical device recall Truliant Tibial Trial Handle The Truliant Tibial Trial Handle’s pin may disassociate from the main body. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Illinois, Nevada, New York, Ohio, Oklahoma, South Carolina and Tennessee

Medical device recall VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance… Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard. Class IIFDA’s classAug 23, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 23, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Washington and Wisconsin named

Medical devices, 2017

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