DURAFLOW 2 Vascular Access Device Recalled for Loose Metal Shavings
Angiodynamics is recalling DURAFLOW 2 vascular access devices due to loose metal shavings that may travel through blood vessels, potentially requiring 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: This is an FDA Class II medical device recall with a serious potential hazard (embolization requiring possible surgical intervention), but no illnesses or injuries have been reported. Per the rubric, this meets criteria for high severity as a risk-of-harm product without reported injury.
Plain-English summary
Angiodynamics, Inc. is recalling DURAFLOW 2 vascular access devices (Product Number H787103012185, Lot 5805849), specifically the Tri-Ball Tunneler component, used to provide long-term vascular access for hemodialysis and apheresis.
The recalled devices may contain loosely affixed metal shavings. These shavings could separate from the device and travel through the bloodstream in a condition called embolization, which may require surgical removal.
The recall affects 83 units distributed to the Veterans Affairs system. Patients with this device should contact Angiodynamics, Inc. for instructions on appropriate next steps.
The recalled product
- Product
- DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012185
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- Affected units
- 83
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: 25051684014820 Lot Numbers: 5805849
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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