FDA Recalls Vascular Access Device Due to Loose Metal Shavings Risk
Angiodynamics' DURAMAX STACKED TIP vascular access device may contain loosely affixed metal shavings that could cause blood vessel blockage, potentially 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 a Class II recall involving a high-risk hazard (potential embolization in a vascular device requiring surgical intervention) where no injuries have been reported. Per the severity rubric, risk-of-harm products with unreported injury warrant a High (3) score.
Plain-English summary
Angiodynamics, Inc. is recalling the DURAMAX STACKED TIP 24CM STR. BASIC KIT, a vascular access device used for long-term hemodialysis and apheresis access. The device may contain loosely affixed metal shavings.
The potential hazard is that metal shavings could become detached and lodge in blood vessels, a condition called embolization. This complication could require surgical intervention to remove the material.
The recall affects 555 units distributed through Veterans Affairs. The affected lot numbers are 5807194, 5809616, and 5809462. Patients and healthcare providers using this device should contact Angiodynamics or their healthcare provider.
No injuries or illnesses have been reported in connection with this issue. However, patients with the affected device should consult their healthcare provider immediately to determine appropriate next steps.
The recalled product
- Product
- DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028035
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- metal-shavings
- embolization
- surgical-intervention-required
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)
- UDI-DI: 25051684011836 Lot Numbers: 5807194
- 5809616
- 5809462
Distribution
Distributed in 1 state:
- VA
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