LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure
LivaNova is recalling 77 Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter during implantation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a procedural failure (inability to collapse the valve) which poses a risk of harm during a medical procedure, but the source text does not report any injuries, illnesses, or fatalities, placing it in the 'High' severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
LivaNova is recalling 77 units of the Perceval Single Use Accessory Kit, Size S (REF: ICV1345). The recall involves specific lots (2002060216, 2002060218) of the Dual Collapser component, which is used to reduce the diameter of the Perceval Sutureless heart valve prior to implantation.
The recall was initiated after LivaNova received complaints indicating that the Perceval valve could not be collapsed during the procedure. This issue is specific to the Dual Collapser size S/M component. The affected kits were distributed nationwide in the United States and in numerous international locations, including Canada, Japan, Germany, and the United Kingdom.
Healthcare providers and patients should stop using the affected kits immediately. LivaNova is the recalling firm and is responsible for managing the recall. No specific instructions for consumers are provided in the source text, but the product is marked as Rx Only, indicating it is intended for use by medical professionals.
The recalled product
- Product
- Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - 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, all
- Manufacturer
- Sorin Group Italia S.r.l.
- Category
- Medical Device — Cardiovascular
- Affected units
- 77
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Kit Lots: 2002060216
- 2002060218
Distribution
Part of a larger recall action
This product is one of 5 recalled by Sorin Group Italia S.r.l. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Sorin Group Italia S.r.l.
See all →- HighLivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure
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