LivaNova Recalls Sterile Standalone Connectors Due to Barrier Breach
LivaNova USA Inc. is recalling 240 units of sterile standalone connectors because internal tests found potential breaches in the sterile barrier.
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 sterile barrier breach in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
LivaNova USA Inc. is recalling 240 units of 1/2 - 3/8 REDUC CONN, STRL REF (GTIN 00803622129322) sterile standalone connectors. The recall involves specific lots (2005500211 and 2004300011) associated with a specific production period and packaging configuration.
The firm identified through internal testing that the sterile barrier of these connectors may present a breach. This defect potentially affects components assembled with the specific packaging mentioned in the recall notice. The agency has classified this as a Class II recall.
The affected units were distributed to facilities in 40 US states, the District of Columbia, and one hospital in Spain (Hospital de Barsuto, Bilbao). Consumers and healthcare providers should check their inventory for the specific lot numbers and product codes listed in the recall notice and contact LivaNova for instructions on return or replacement.
The recalled product
- Product
- 1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 240
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 2005500211
- 2004300011
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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