Biosense Webster PENTARAY NAV Mapping Catheter Recall for Entrapment Risk
Biosense Webster is recalling PENTARAY NAV High-Density Mapping Catheters because they can become entrapped in the cardiac valvular apparatus during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Biosense Webster is recalling the PENTARAY NAV eco High-Density Mapping Catheter, a sterile, prescription-only medical device used for electrophysiological mapping of cardiac structures. The recall covers 435,590 units distributed worldwide, including across the United States and various international regions.
The recall is being issued because the mapping catheter can become entrapped in the cardiac valvular apparatus while a user is attempting to create an electroanatomic map. This defect poses a risk of harm to patients during the procedure.
Healthcare providers and facilities that have received these devices should stop using them immediately. Users should contact Biosense Webster for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recor
- Manufacturer
- BIOSENSE WEBSTER
- Hazard
- Affected units
- 435,590
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- D-1282-08
- F
Distribution
Part of a larger recall action
This product is one of 2 recalled by BIOSENSE WEBSTER under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · BIOSENSE WEBSTER
See all →- HighBiosense Webster Recalls PENTARAY NAV High-Density Mapping Catheters
FDA (Devices) · 2020-06-24
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