Medical Device Recall: Angiodynamics DURAMAX Tunneler with Metal Shavings
Angiodynamics is recalling DURAMAX STACKED TIP medical devices that may contain loosely affixed metal shavings with potential to embolize, requiring possible surgical removal. The recall affects 50 units distributed in Virginia.
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 involving a real medical hazard where metal shavings could embolize and require surgical intervention. Although no illnesses or injuries are reported in the source, the device poses significant risk of patient harm, fitting the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Angiodynamics, Inc. is recalling the DURAMAX STACKED TIP 24CM STR. BASIC KIT (Product Number H787103028031) due to the potential presence of loosely affixed metal shavings.
The metal shavings may separate from the device and embolize (travel through blood vessels), potentially causing harm to patients and requiring surgical removal. This poses a risk to patients who receive these devices.
The recall involves 50 units with lot number 5809463 that were distributed in Virginia. Patients who received these devices and healthcare providers should contact Angiodynamics, Inc. for further instructions. Any patients experiencing symptoms related to the device should seek medical attention.
The recalled product
- Product
- DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031
- Manufacturer
- Angiodynamics, Inc.
- Category
- Medical Device
- 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: 15051684011839 Lot Numbers: 5809463
Distribution
Distributed in 1 state:
- VA
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