FDA DevicesClass II
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB...
Published: April 29, 2026Recall ID: Z-1862-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;
Affected Products
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;
Additional Source Details
| Field | Value |
|---|---|
| City | Queensbury |
| State | NY |
| Event id | 98463 |
| Address 1 | 603 Queensbury Ave |
| Address 2 | N/A |
| Code info | SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); UDI-DI: 25051684007891(Box), 15051684007894(Pouch); Lot No.: A2825033, A2825034, A2825132, A2825133, A3725048, A3725049; |
| Postal code | 12804-7619 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 4925 units (985 boxes) |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260303 |
| Initial firm notification | Letter |
| Center classification date | 20260417 |
Overview
- Recalling FirmAngiodynamics, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.