Angiodynamics Duramax Vascular Access Kit Recall Due to Metal Shavings
Angiodynamics recalls the Duramax Stacked Tip vascular access kit used for hemodialysis due to potential loose metal shavings that could enter the bloodstream and require surgical removal.
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: FDA Class II medical device with potential for serious harm (embolization requiring possible surgery) if the manufacturing defect occurs. No illnesses or injuries have been reported, which per the rubric limits the score to at most 3, qualifying as High-risk.
Plain-English summary
Angiodynamics, Inc. is recalling the DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG (Product Number: H787103028045), a medical device used to establish long-term vascular access for hemodialysis and apheresis procedures.
The Tri-Ball Tunneler component may contain loosely affixed metal shavings. These shavings could become dislodged and embolize—enter the bloodstream—potentially requiring surgical removal.
The recall affects 40 units distributed to VA facilities. Affected lot number is 5807204 (UDI-DI: 25051684011843). Healthcare providers and patients with this device should contact Angiodynamics for guidance on appropriate management steps.
The recalled product
- Product
- DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028045
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- Affected units
- 40
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)
- UDI-DI: 25051684011843 Lot Numbers: 5807204
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 15 recalled by Angiodynamics, 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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