Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Perceval Dual Collapser Recalled by Sorin Group Italia S.r.l. Due to LivaNova received complaints indicating the impossibility to collapse...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sorin Group Italia S.r.l. directly.
Affected Products
Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he 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.
Quantity: 498 units (component in kits 1-4)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sorin Group Italia S.r.l.
Sorin Group Italia S.r.l. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report