AngioVac Circuit Packs Recalled for Excessive Endotoxin Levels
AngioDynamics is recalling AngioVac Circuit Packs because they may contain RotaFlow Centrifugal Pumps with endotoxin levels exceeding regulatory limits.
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 high-risk pathogen (endotoxin) in a sterile medical device where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
AngioDynamics Inc. (Navilyst Medical Inc.) is recalling AngioVac Circuit Packs (Tandem Packs) because the products may possess levels of endotoxin that exceed regulatory limits. The recall involves 377 kits distributed nationwide.
The issue was identified after Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the pumps may contain excessive endotoxin. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in the packaged AngioVac Circuit Packs.
The affected products are sterile, single-use, prescription-only medical devices. Consumers and healthcare providers should stop using the recalled items and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Hazard
- Affected units
- 377
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 (16)
- Lot Numbers: 4876386
- 4889699
- 4889700
- 4898652
- 4902111
- 4902117
- 4906576
- 4941511
- 4941511D
- 4943459
- 4955686
- 4956929
- 4969475
- 4975493
- 4991710
- 4999714.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Angiodynamics Inc. (Navilyst Medical 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.
See all 2 products in this recall →Related recalls
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