Biosense Webster recalls PENTARAY NAV High-Density Mapping Catheter electrodes due to risk of entrapment in cardiac valves during electroanatomic mapping procedures. Affected units include specific product codes manufactured from 2016 onward.
Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
Biosense Webster is recalling certain PENTARAY NAV High-Density Mapping Catheter electrodes because they can become stuck in heart valves while creating cardiac maps. This could lead to serious complications during medical procedures.
The catheter can get trapped in the heart's valve structures while a doctor is creating detailed electrical maps of the heart. This entrapment might cause damage to the valve or surrounding tissues during the procedure.
Medical professionals using the catheter for cardiac mapping procedures are most at risk. Patients undergoing these procedures with the recalled catheters could face complications.
Check for product codes D-1282-07, D-1282-08, D-1282-10, or D-1282-11 on the catheter packaging. These specific models were manufactured from 2016 onward and are affected by this recall.
Look for product codes D-1282-07, D-1282-08, D-1282-10, or D-1282-11 on the catheter packaging to confirm if it's affected.
The catheter can become entrapped in the cardiac valvular apparatus while creating electroanatomic maps, potentially causing serious complications during procedures.
Product codes D-1282-07, D-1282-08, D-1282-10, and D-1282-11 were manufactured from 2016 onward and are affected by this recall.
The recall does not require immediate discontinuation; medical professionals should check the product code and follow the provided steps to ensure safety.
We’ve drafted a message you can send Biosense Webster to request your refund or repair — edit it as you like.
Subject: Recall Z-2371-2020 — Biosense Webster Biosense Webster Hello, I own a Biosense Webster that is covered by recall Z-2371-2020 from Biosense Webster. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
