AngioVac Circuit Recall Due to Potential Endotoxin Levels
Angiodynamics is recalling Vortex MEDICAL AngioVac Circuits because they may contain 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 medical device with a potential contamination hazard (endotoxin) exceeding regulatory limits, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling the Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100. The recall involves 339 kits distributed nationwide. The affected products are sterile, prescription-only, single-use circuits designed to be used with the AngioVac Cannula.
The recall was initiated because the manufacturer determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps, which were the source of the endotoxin concern, were included in the packaged AngioVac Circuit Packs.
The affected lot numbers are 37FE2901, 37GD2908, and 37KD2405. Healthcare facilities and consumers should stop using these products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, 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
- 339
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 (3)
- Lot Numbers 37FE2901
- 37GD2908
- 37KD2405
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.
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