Sorin Group recalls Perceval Single Use Accessory Kit Size M (lot 2002060219-2002060220) due to potential inability to collapse the Dual Collapser component during heart valve implantation.
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M.
Sorin Group recalls Perceval Single Use Accessory Kit Size M (lot 2002060219-2002060220) because the Dual Collapser component may not collapse properly during heart valve procedures. This could affect the successful implantation of the Perceval sutureless heart valve.
The Dual Collapser component is designed to reduce the Perceval sutureless heart valve diameter before implantation. If it cannot collapse properly during surgery, the valve may not fit correctly, potentially causing complications during the procedure.
Healthcare professionals using the Perceval Single Use Accessory Kit Size M for heart valve procedures are most at risk. Patients receiving this specific kit during surgery may be affected if the Dual Collapser fails to collapse.
Check for the Perceval Single Use Accessory Kit Size M with lot numbers 2002060219 or 2002060220. The kit includes the Dual Collapser component used to adjust the valve size before implantation.
Look for lot numbers 2002060219 or 2002060220 on the kit packaging.
The recall indicates potential issues with the Dual Collapser component during procedures, so it is not recommended for use until the remedy is confirmed.
The recall does not specify a remedy, so contact Sorin Group directly for guidance on next steps.
The recall states the Dual Collapser may not collapse during procedures, so it is not safe to use without further confirmation.
We’ve drafted a message you can send Sorin Group to request your refund or repair — edit it as you like.
Subject: Recall Z-2985-2020 — Sorin Group Sorin Group Hello, I own a Sorin Group that is covered by recall Z-2985-2020 from Sorin Group. 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.
