Sorin Group recalls Perceval Single Use Accessory Kit Size M (lot numbers listed) due to inability to collapse valve during heart surgery. This affects specific medical devices used in sutureless heart valve procedures.
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 is recalling Perceval Single Use Accessory Kits (Size M) because the Dual Collapser component may not collapse properly during heart surgery. This could lead to complications in valve implantation procedures.
The Dual Collapser component is designed to reduce the heart valve diameter before implantation. If it cannot collapse as intended, the valve may not fit properly during surgery, causing potential complications.
Healthcare professionals using the Perceval Sutureless heart valve system during surgery are most at risk. Patients receiving this specific kit for heart valve procedures may be affected.
Check for the Perceval Single Use Accessory Kit, Size M with lot numbers: 2002200199, 2002200198, 2002130162, 2002130160, 2002060224, 2001300341, 2002130161. The kit includes a Dual Collapser component for valve size reduction.
Identify the lot numbers on your Perceval Single Use Accessory Kit (Size M) to see if they match the recalled lots: 2002200199, 2002200198, 2002130162, 2002130160, 2002060224, 2001300341, 2002130161.
The Dual Collapser component may not collapse properly during heart surgery, which could lead to complications in valve implantation.
Check the lot numbers on your kit to see if it is in the recalled list. If it is, contact your healthcare provider for guidance.
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-2987-2020 — Sorin Group Sorin Group Hello, I own a Sorin Group that is covered by recall Z-2987-2020 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.
