Sorin recalls Perceval Dual Collapser size S/M (lot 2002130166) due to inability to collapse valve during heart surgery. This accessory kit component may cause improper 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 is recalling Perceval Dual Collapser size S/M products because they may not collapse properly during heart valve procedures. This could lead to improper valve implantation and potential complications for patients needing heart surgery.
The Dual Collapser is a component that reduces the heart valve diameter before implantation. When it fails to collapse during surgery, the valve may not fit properly, potentially causing improper implantation and complications.
Patients undergoing heart surgery who use the Perceval Sutureless heart valve system with the recalled Dual Collapser size S/M may be affected. Medical professionals using this specific component in procedures are at highest risk.
Check for the Perceval Dual Collapser size S/M with reference number ICV1235 and unique device identifier (UDI) 08022057014832. This specific lot number (2002130166) was affected.
Verify the Perceval Dual Collapser size S/M with reference number ICV1235 and UDI 08022057014832.
The recall is due to complaints that the Perceval Dual Collapser size S/M cannot collapse properly during heart valve procedures, which may lead to improper implantation.
The Dual Collapser is a component that reduces the heart valve diameter before implantation. When it fails to collapse during surgery, the valve may not fit properly.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Sorin Group to request your refund or repair — edit it as you like.
Subject: Recall Z-2988-2020 — Sorin Group Sorin Group Hello, I own a Sorin Group that is covered by recall Z-2988-2020 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.
