LivaNova Recalls Vein Irrigation Cannulas Due to Sterile Barrier Breach
LivaNova USA Inc. is recalling 150 units of Vein Irrigation Cannulas with blunt tips because internal tests identified 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are classified as Severe (4). A sterile barrier breach is a structural defect that compromises the safety of the device.
Plain-English summary
LivaNova USA Inc. is recalling 150 units of Vein Irrigation Cannulas with blunt tips (ASY BIC, STERILE 25/CS). The recall involves a specific production period and packaging configuration. The firm identified through internal tests that the sterile barrier of these devices may present a breach.
The affected units are associated with Lot 2004900018. Distribution records indicate the products were shipped to various US states, including AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. One unit was also distributed to Hospital de Barsuto in Bilbao, Spain.
The FDA has classified this as a Class II recall. A breach in the sterile barrier of a medical device intended for vein irrigation poses a risk of infection or other adverse health consequences if the device is used. Users should stop using the affected units and contact LivaNova USA Inc. for instructions on return or replacement.
The recalled product
- Product
- Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091
- Manufacturer
- LivaNova USA Inc.
- Affected units
- 150
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 2004900018
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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