Pentaray NAV High-Density Mapping Catheter
Medical device recall Z-1590-2016. 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
- 13,912 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 Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 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.
13,912 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
15798659L 15795833L 15805361L 15782835L 15793498L 15795840L 15808937L 15803354L 15801125L 15805364L 15808933L 15808940L 15790718L 15799746L 15800549L 15795194L 15795197L 15800489L 15814334L 15814875L 15811695L 15811699L 15815788L 15782017L…
Every code shown here, 2,000 characters
15798659L 15795833L 15805361L 15782835L 15793498L 15795840L 15808937L 15803354L 15801125L 15805364L 15808933L 15808940L 15790718L 15799746L 15800549L 15795194L 15795197L 15800489L 15814334L 15814875L 15811695L 15811699L 15815788L 15782017L 15801124L 15801127L 15799738L 15799744L 15819531L 15800485L 15804551L 15814337L 15814339L 15814869L 15811196L 15811200L 15816732L 15806214L 15820998L 15805358L 15825347L 15808939L 15784813L 15787804L 15825339L 15815350L 15819522L 15819524L 15819529L 15825880L 15809778L 15810494L 15814871L 15820209L 15820199L 15820207L 15820210L 15816738L 15820991L 15820993L 15821008L 15803346L 15805362L 15808934L 15825889L 15825893L 15828085L 15828089L 15795201L 15809773L 15816737L 15820994L 15805360L 15808932L 15808938L 15825342L 15825881L 15825887L 15825891L 15828086L 15828087L 15828088L 15828090L 15831087L 15803968L 15814332L 15822449L 15822451L 15826600L 15828094L 15825882L 15811195L 15811692L 15827318L 15815787L 15825348L 15835412L 15835415L 15820212L 15821738L 15822458L 15822463L 15826605L 15828092L 15831082L 15831085L 15832438L 15832441L 15833155L 15833156L 15833158L 15833160L 15833164L 15835566L 15835571L 15831852L 15831854L 15839707L 15839406L 15847790L 15831855L 15837113L 15803352L 15808935L 15808941L 15830258L 15830262L 15830263L 15835408L 15835417L 15845015L 15825341L 15810500L 15828093L 15836394L 15840280L 15814849L 15839402L 15839404L 15843376L 15844332L 15844335L 15849431L 15821006L 15815791L 15816734L 15830260L 15830261L 15830267L 15835410L 15845014L 15845016L 15845017L 15847690L 15847691L 15847697L 15837784L 15840292L 15843380L 15832440L 15833157L 15833159L 15839401L 15844340L 15849432L 15839408L 15843374L 15844333L 15844347L 15844350L 15840932L 15840935L 15837774L 15837778L 15839410L 15843377L 15850674L 15859160L 15862714L 15820205L 15821731L 15832445L 15845949L 15867139L 15832444L 15843381L 15845954L 15871422L 15880802L 15892035L 15867137L 15867141L 15821729L 15822468L 15826601L 15886633L 15892039L 15820202L 15860429L 15862037L…
FDA’s list runs to 18,820 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 18,820 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.