LivaNova Recalls Vein Irrigation Cannulas Due to Sterile Barrier Breach
LivaNova is recalling 325 Vein Irrigation Cannulas because internal tests found potential breaches in the sterile barrier, which could compromise sterility.
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. The hazard involves a potential sterile barrier breach, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
LivaNova USA Inc. is recalling 325 units of Vein Irrigation Cannula with blunt tip (ASY VIC, STERILE 25/CS). The recall is associated with specific production periods and packaging configurations.
The firm identified through internal tests that the sterile barrier of these devices may present a breach. This issue potentially affects components assembled with a specific packaging type. The recall covers distribution in 43 US states and the District of Columbia, as well as one hospital in Spain.
Healthcare providers and consumers should check their inventory for the affected lot numbers (2004300013; 2005500214) and stop using the devices if they match the recalled description. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 325
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)
- LOT 2004300013
- 2005500214
Distribution
Part of a larger recall action
This product is one of 22 recalled by LivaNova USA Inc. 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.
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