LivaNova Recalls Sterile Standalone Connectors Due to Potential Barrier Breach
LivaNova USA Inc. is recalling specific lots of sterile standalone connectors because internal tests found the sterile barrier may be breached.
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 involves a potential breach of the sterile barrier on a medical device, which poses a risk of harm (infection) even though no injuries or illnesses have been reported in the source text.
Plain-English summary
LivaNova USA Inc. is recalling 48 units of Sterile Standalone Connectors (Lot 2004300004) because internal tests identified that the sterile barrier of certain units may present a breach. The issue potentially affects components assembled with a specific packaging and associated with a specific production period.
The recalled products were distributed to facilities in the United States and to a hospital in Spain. The source text does not specify the exact number of affected units beyond the 48 units listed in the structured data, nor does it provide specific dates for the production period or distribution.
Healthcare facilities should stop using the affected connectors and contact LivaNova USA Inc. for further instructions. Consumers are not expected to have these medical devices in their possession.
The recalled product
- Product
- Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 48
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 2004300004
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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