LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure
LivaNova is recalling specific lots of 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, and the hazard involves a medical device failure during a procedure where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
LivaNova is recalling specific lots of Perceval Single Use Accessory Kits, Size M, manufactured by Sorin Group Italia S.r.l. The recall involves 225 kits distributed nationwide in the United States and internationally. The affected product is a sterile, single-use accessory kit used in medical procedures.
The recall was initiated after LivaNova received complaints indicating that the Perceval valve could not be collapsed during a procedure. The Dual Collapser is a component of these kits designed to reduce the diameter of the Perceval Sutureless heart valve before implantation. The issue is specific to certain lots of the Dual Collapser in sizes S and M.
Healthcare providers and patients should stop using the affected lots immediately. The specific lot numbers involved are 2002200199, 2002200198, 2002130162, 2002130160, 2002060224, 2001300341, and 2002130161. Users should contact LivaNova or their medical provider for further instructions on how to proceed with the recall.
The recalled product
- Product
- Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - 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, allo
- Manufacturer
- Sorin Group Italia S.r.l.
- Category
- Medical Device — Cardiovascular
- Affected units
- 225
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 (5)
- Kit Lots: 2002200199
- 2002200198
- 2002130162
- 2002130160
- 2002060224 20013003412002130161
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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