Angiodynamics, Inc. recalls Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU
See all recalls from Angiodynamics, Inc. →Recalled Product
Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;
Hazard / Issue
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; UDI-DI: 25051684007440 (Box), 15051684007443 (Pouch); Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Lot No.: A3625012, A3825055;
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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