Vascular catheter recalled for potential metal shavings that may cause embolization
Angiodynamics recalled a vascular access catheter used for hemodialysis because it may contain loosely affixed metal shavings. These shavings could potentially detach and move through blood vessels, possibly requiring surgical removal.
What this means for you
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: This is an FDA Class II recall of a vascular access catheter with potential for metal shavings that could cause embolization requiring surgical intervention. Per the rubric, FDA Class II recalls with hospitalization reports are Severe (4); this recall documents a risk-of-harm situation without documented hospitalizations, placing it in the High (3) category.
Plain-English summary
Angiodynamics, Inc. has recalled the DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK vascular access catheter, used to establish long-term vascular access for hemodialysis and apheresis procedures.
The product may contain loosely affixed metal shavings that could potentially detach from the catheter. If these shavings enter the bloodstream, they may cause embolization—the migration or lodging of foreign material in blood vessels—which could require surgical removal.
This recall affects lot number 5809464, which consisted of 50 units distributed in Virginia.
The recalled product
- Product
- DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028201
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- metal-shavings
- embolization
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: 15051684011945 Lot Numbers: 5809464
Distribution
Distributed in 1 state:
- VA
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