Biosense Webster recalls WaveCrest Left Atrial Appendage (LAA) 32mm occlusion systems (catalog numbers WCR1523, WCR2523) due to risk of device failure during recapture attempts.
When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle, resulting in increased retraction force and difficulty or failure to recapture the device.
Biosense Webster is recalling WaveCrest Left Atrial Appendage (LAA) 32mm occlusion systems (catalog numbers WCR1523 and WCR2523) because the device may fold or buckle during recapture attempts, causing increased retraction force and potential failure to properly secure the device.
When attempting to recapture the 32mm device, the tip of the delivery sheath may fold or buckle. This causes increased retraction force and can lead to difficulty or failure to properly secure the device during cardiac procedures.
Medical professionals who use the WaveCrest LAA 32mm occlusion systems for cardiac procedures are most at risk during device recapture attempts.
Check for WaveCrest Left Atrial Appendage (LAA) 32mm occlusion systems with catalog numbers WCR1523 or WCR2523. All lots of this product are affected.
Verify if your device has catalog numbers WCR1523 or WCR2523 for the WaveCrest LAA 32mm occlusion system.
The recall indicates a risk during recapture attempts, but the device is not unsafe for normal use. Medical professionals should follow the recall instructions.
The recall record does not specify a remedy, so contact Biosense Webster directly for guidance.
Look for WaveCrest Left Atrial Appendage (LAA) 32mm occlusion systems with catalog numbers WCR1523 or WCR2523. All lots are affected.
We’ve drafted a message you can send Biosense Webster to request your refund or repair — edit it as you like.
Subject: Recall Z-2878-2018 — Biosense Webster Biosense Webster Hello, I own a Biosense Webster that is covered by recall Z-2878-2018 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.
