LivaNova Recalls Perceval Dual Collapser Due to Valve Collapse Failure
LivaNova is recalling specific lots of the Perceval Dual Collapser because complaints indicate the device may fail to collapse the heart valve 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 involves a high-risk medical device where a functional failure (inability to collapse the valve) poses a risk of harm during a surgical procedure, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
LivaNova is recalling specific lots of the Perceval Dual Collapser, a component used in single-use accessory kits for the Perceval Sutureless heart valve. The Dual Collapser is designed to reduce the diameter of the heart valve before implantation. The recall is limited to the S/M size of the device.
The recall was initiated after LivaNova received complaints indicating that it was impossible to collapse the Perceval valve during the procedure. This issue is relevant to specific lots of the Dual Collapser size S/M.
The affected product is distributed nationwide in the United States and in numerous international countries. The specific lot number is 2002130166. The total quantity involved is 498 units, which are components in kits 1-4. Healthcare providers and patients should stop using the affected product and contact LivaNova for further instructions.
The recalled product
- Product
- Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - 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 t
- Manufacturer
- Sorin Group Italia S.r.l.
- Category
- Medical Device — Cardiovascular
- Hazard
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 (1)
- Lot: 2002130166
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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