Reported Dec 13, 2017 · Terminated
PENTARAY NAV High-Density Mapping Catheter.
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 Catheter.
- Lot codes and dates
- Product
- code (Product Description) (GTIN)
D-1282-07-S (NAV ECO 7FRF4-4-4) (10846835012217)D-1282-08-S (NAV ECO 7FRF2-6-2) (10846835012224)D-1282-09-S (NAV ECO 7FRF1-8-1) (10846835012231)D-1282-10-S (NAV ECO 7FRD4-4-4) (10846835012248)D-1282-11-S (NAV ECO 7FRD2-6-2) (10846835012255)D-1282-12-S (NAV ECO 7FRD1-8-1) (1846835012262)
- Amount recalled
- 73,796 units total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Biosense Webster, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.