LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure
LivaNova is recalling 102 Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter, preventing 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 involves a medical device failure that prevents a necessary surgical step (valve collapse), creating a risk of harm or procedural failure, but the source text does not report any injuries, illnesses, or fatalities.
Plain-English summary
LivaNova is recalling 102 Perceval Single Use Accessory Kits, Size S, manufactured by Sorin Group Italia S.r.l. The recall involves specific lots of the Dual Collapser component, which is used to reduce the diameter of the Perceval Sutureless heart valve before 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 countries including Canada, Japan, Germany, and the United Kingdom.
Healthcare providers and patients should stop using the affected kits immediately. The specific lot numbers involved are 2002200196, 2001300339, and 2002130159. Users should contact LivaNova or their medical device supplier for further instructions on how to return or replace the product.
The recalled product
- Product
- 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, allow
- Manufacturer
- Sorin Group Italia S.r.l.
- Category
- Medical Device — Cardiovascular
- Affected units
- 102
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 (3)
- Kit Lots: 2002200196
- 2001300339
- 2002130159
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
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