Sorin Group recalls Perceval Single Use Accessory Kit Size S due to potential inability to collapse valve during heart surgery. Affected kits have specific lot numbers. Contact for remedy.
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 for heart valve procedures. The issue prevents the valve from collapsing properly during surgery, which could lead to complications.
The Dual Collapser component may not collapse correctly during surgery. This prevents the valve from being properly sized before implantation, potentially causing surgical complications.
Heart surgery patients using Perceval Sutureless heart valve kits with specific lot numbers. Surgeons and medical teams handling these kits are most at risk.
Check for lot numbers: 2002200196, 2001300339, or 2002130159 on the kit packaging. The kit is labeled as Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211.
Look for lot numbers 2002200196, 2001300339, or 2002130159 on the kit packaging.
The Dual Collapser component may not collapse properly during surgery, preventing the valve from being correctly sized before implantation.
Check the lot number on the kit packaging. If it matches the affected lots, contact Sorin Group for instructions.
The recall is due to potential surgical complications from improper valve sizing, but the remedy does not specify immediate stop-use or return.
We’ve drafted a message you can send Sorin Group to request your refund or repair — edit it as you like.
Subject: Recall Z-2986-2020 — Sorin Group Sorin Group Hello, I own a Sorin Group that is covered by recall Z-2986-2020 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.
