Reported Jun 24, 2020 · Terminated
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster…
Biosense Webster
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 · 33 TECHNOLOGY DRIVE · IRVINE, CA · 92618
Is this the product you have?
- PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22
- Rx only STERILE EO - Product UsageThe Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Barcodes Product as published 4-4-410846835009576D-1282-02-S PENTARAY¿ NAV, 7FR, F 2-6-210846835009583D-1282-03-S PENTARAY¿ NAV, 7FR, F 1-8-110846835009590D-1282-04-S PENTARAY¿ NAV, 7FR, D 4-4-410846835009606D-1282-05-S PENTARAY¿ NAV, 7FR, D 2-6-210846835009613D-1282-06-S PENTARAY¿ NAV, 7FR, D 1-8-110846835009620Note - the firm is including the above code information for products that will be distributed to new customers. No Lot Numbers. - Amount recalled
- 0 units (Products were not manufactured from 2016 and later)
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
Why it was recalled
Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
This product could cause temporary or reversible health problems — stop using it.
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