DURAMAX vascular catheter recalled for possible metal shaving hazard
The DURAMAX STACKED TIP vascular catheter may contain loosely affixed metal shavings that could embolize and require surgical removal. Lot 5807208 affected, 15 units.
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 surgical removal) but no injuries reported. Per rubric: 'risk-of-harm products where injury has not yet been reported' scores as High (3).
Plain-English summary
Angiodynamics, Inc. is recalling the DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK vascular catheter (Product Number H787103028191) indicated for long-term hemodialysis and apheresis access.
The Tri-Ball Tunneler component may contain loosely affixed metal shavings. If present, these shavings could potentially embolize and travel through blood vessels, potentially requiring surgical removal.
Approximately 15 units with Lot Number 5807208 (UDI-DI: 25051684011850) were distributed to the VA. Patients and healthcare providers who have received this product should contact Angiodynamics, Inc. for information about whether their units are affected and for guidance on next steps.
The recalled product
- Product
- DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028191
- Manufacturer
- Angiodynamics, Inc.
- Category
- Medical Device — Vascular Access
- Affected units
- 15
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: 25051684011850 Lot Numbers: 5807208
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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