Reported May 11, 2016 · Terminated
Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The…
Biosense Webster, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biosense Webster, Inc. · 15715 Arrow Hwy · Irwindale, CA · 91706-2006
Is this the product you have?
- 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.
- Lot codes and dates
2,964 of 2,964 codes
16050993L16052415L16050242L16049660L16054298L16053514L16054297L16052414L16053513L16053516L16050992L15990830L16012853L16047426L16054299L16048721L17055438L17058924L17064807L17066297L17055454L17069067L17064806L17069961L17069964L17051780L17069065L17069066L17052759L17052760L17053741L17065103L17053740L17053742L17059593L17059595L17058925L17058929L17059594L17058930L17059596L17059592L17055455L17055437L17050534L17066833L17066832L17103225L17100630L17103709L17104144L17100633L17187339L17187331L17186424L17187338L17187334L17183074L17173411L17172912L
- Amount recalled
- 59,672 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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