Pentaray NAV High-Density Mapping ECO Catheter
Medical device recall Z-1591-2016. Published in FDA’s Enforcement Report on May 11, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 11, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 59,672 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.
59,672 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
16050993L 16052415L 16050242L 16049660L 16054298L 16053514L 16054297L 16052414L 16053513L 16053516L 16050992L 15990830L 16012853L 16047426L 16054299L 16048721L 17055438L 17058924L 17064807L 17066297L 17055454L 17069067L 17064806L 17069961L…
Every code shown here, 2,000 characters
16050993L 16052415L 16050242L 16049660L 16054298L 16053514L 16054297L 16052414L 16053513L 16053516L 16050992L 15990830L 16012853L 16047426L 16054299L 16048721L 17055438L 17058924L 17064807L 17066297L 17055454L 17069067L 17064806L 17069961L 17069964L 17051780L 17069065L 17069066L 17052759L 17052760L 17053741L 17065103L 17053740L 17053742L 17059593L 17059595L 17058925L 17058929L 17059594L 17058930L 17059596L 17059592L 17055455L 17055437L 17050534L 17066833L 17066832L 17103225L 17100630L 17103709L 17104144L 17100633L 17187339L 17187331L 17186424L 17187338L 17187334L 17183074L 17173411L 17172912L 17172049L 17186423L 17186426L 17173416L 17183072L 17186422L 17169225L 17166017L 17173131L 17182426L 17181315L 17182429L 17177947L 17177950L 17173419L 17173414L 17177952L 17148553L 17148570L 17152997L 17165843L 17165844L 17165845L 17176640L 17177946L 17182419L 17182416L 17176183L 17177228L 17182424L 17183068L 17183066L 17182423L 17182420L 17183069L 17183070L 17183071L 17172068L 17172069L 17173137L 17173445L 17173133L 17173443L 17171926L 17172070L 17173134L 17176182L 17173417L 17173418L 17177945L 17177951L 17176180L 17176181L 17175535L 17182425L 17172050L 17172910L 17172045L 17190460L 17190462L 17172906L 17172911L 17187336L 17187341L 17165854L 17166016L 17182427L 17182417L 17182415L 17183067L 17172908L 17183062L 17182422L 17183061L 17182421L 17182414L 17165787L 17172038L 17172042L 17172041L 17172043L 17177230L 17181313L 17177948L 17173132L 17180290L 17177949L 17172039L 17173130L 17177229L 17180288L 17187337L 17186425L 17177953L 17172047L 17173413L 17172913L 17173412L 17173420L 17172907L 17172040L 17172909L 17187340L 17177231L 17177234L 17177233L 17180289L 17177235L 17177232L 17172044L 17173415L 17172048L 17172046L 17181314L 17183063L 17181311L 17182418L 17183073L 17183065L 17180287L 17181312L 17176641L 17182428L 17238463L 17237752L 17239368L 17239369L 17246886L 17242371L 17242372L 17243423L 17242370L 17243424L 17242749L 17247596L 17241105L 17237751L 17242643L 17235859L 17239371L…
FDA’s list runs to 32,160 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution: US (Nationwide) and countries of: Canada, China, Hong Kong, Indonesia, India, Japan, Korea, Malaysia, New Zealand, Singapore, Thailand, Taiwan, United Arab Emirates, Austria, Belgium, Bulgaria, Switzerland, Czech Republic, Germany, Denmark, Algeria, Spain, Finland, France, United Kingdom, Greece, Hungary, Ireland, Israel, Iraq, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sweden, Turkey, South Africa.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 14, 2016.
- FDA classified it on Apr 29, 2016.
- FDA’s Enforcement Report published it on May 11, 2016.
- FDA terminated it on Oct 14, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Biosense Webster, Inc., of Irwindale, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 32,160 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.