Vascular access device recalled for potential metal shavings embolism risk
Angiodynamics recalls DURAMAX STACKED TIP vascular access devices that may contain loosely affixed metal shavings. Metal shavings could embolize and potentially 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 recall of a vascular access device where metal shavings may embolize and potentially require surgical removal. No illnesses or injuries have been reported, consistent with a risk-of-harm product without documented harm.
Plain-English summary
Angiodynamics, Inc. is recalling the DURAMAX STACKED TIP 32CM STR. BASIC KIT, a medical device used for vascular access in hemodialysis and apheresis patients. The recall affects 260 units from lot 5809646 that were distributed in Virginia.
The Tri-Ball Tunneler component may contain loosely affixed metal shavings. These shavings could embolize, potentially requiring surgical intervention to remove.
Patients and healthcare providers should verify whether affected devices are in use. Contact Angiodynamics, Inc. with lot number 5809646 for product replacement or corrective action guidance.
The recalled product
- Product
- DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028055
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- Affected units
- 260
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: 5809646
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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