LivaNova Perfusion Packs Recalled for Potential Leaks or Occlusions
LivaNova USA is recalling 483 sterile perfusion packs because stopcocks may leak or become occluded during surgical procedures.
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 the hazard involves a medical device used in surgical procedures that may leak or occlude, posing a risk of harm without reported injuries.
Plain-English summary
LivaNova USA is recalling 483 units of Perfusion Packs, Rx only, Sterile EO. These products are indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
The recall was initiated because the 4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems may leak or be occluded. The affected units were distributed to consignees in the United States and Canada.
Healthcare providers and patients should check their inventory for the specific lot numbers listed in the official recall notice. If a unit is affected, it should be removed from service and returned to LivaNova USA or the distributor for credit or replacement.
The recalled product
- Product
- Perfusion Pack, Rx only, Sterile EO
- Manufacturer
- LivaNova USA
- Category
- Medical Device — Surgical Tubing
- Affected units
- 483
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 (20)
- Lot Numbers: 1819000027
- 1813500044
- 1809300053
- 1817900004
- 1821900089
- 1812100018
- 1816200009
- 1817600016
- 1810600004
- 1811400014
- 1812000017
- 1812700017
- 1813500013
- 1815500011
- 1816400023
- 1809400005
- 1811600025
- 1812000018
- 1812700018
- 1813500014
Distribution
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