FDAJuly 29, 2020device
Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - 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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
sorin group italia s r lsorinsorin group
UPCs
8022057015211
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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