LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure
LivaNova is recalling 94 Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter, preventing implantation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a high-risk medical device where a functional failure prevents a critical surgical procedure, but no injuries or illnesses are reported in the source text.
Plain-English summary
LivaNova is recalling 94 units of the Perceval Single Use Accessory Kit, Size M (REF: ICV1346). The recall involves specific lots (2002060219 and 2002060220) 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. The affected kits were distributed nationwide in the US and in numerous international countries.
Healthcare providers and patients should stop using the affected kits and contact LivaNova for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - 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…
- Manufacturer
- Sorin Group Italia S.r.l.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 94
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: 2002060219
- 2002060220
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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