FDA DevicesClass II
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM ...
Published: April 29, 2026Recall ID: Z-1863-2026Category: 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, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;
Affected Products
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (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 BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); UDI-DI: 25051684007914(Box), 15051684007917(Pouch); Lot No.: A2525098; |
| Postal code | 12804-7619 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 1030 units (206 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.