Sorin recalls Perceval Single Use Accessory Kit Size S with Dual Collapser component that may not collapse during heart valve procedures. Affected lots: 2002060216, 2002060218.
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 S (lot numbers 2002060216 and 2002060218) because the Dual Collapser component may not collapse during heart valve procedures. This could prevent proper valve implantation.
The Dual Collapser component is designed to reduce the heart valve diameter before implantation. If it fails to collapse as intended, the valve may not fit correctly, potentially causing complications during surgery.
Healthcare professionals using the Perceval Sutureless heart valve system during cardiac procedures. Patients receiving this specific kit are at risk if the valve cannot be properly implanted.
Check for lot numbers 2002060216 or 2002060218 on the Perceval Single Use Accessory Kit Size S packaging. The kit includes the Dual Collapser component for valve size reduction.
Look for lot numbers 2002060216 or 2002060218 on the Perceval Single Use Accessory Kit Size S packaging.
The Dual Collapser component may not collapse during procedures, which could prevent proper valve implantation.
The recall record does not specify a remedy, so contact Sorin Group for guidance.
The recall indicates potential issues with the Dual Collapser component, so it should not be used until the manufacturer provides instructions.
We’ve drafted a message you can send Sorin Group to request your refund or repair — edit it as you like.
Subject: Recall Z-2984-2020 — Sorin Group Sorin Group Hello, I own a Sorin Group that is covered by recall Z-2984-2020 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.
