Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx Recalled by BIOSENSE WEBSTER Due to Mapping Catheter can become entrapped in the cardiac...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact BIOSENSE WEBSTER directly.
Affected Products
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., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Quantity: 435590 units
Why Was This Recalled?
Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About BIOSENSE WEBSTER
BIOSENSE WEBSTER has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report