Soft-Vu pigtail angiographic catheters may block the appropriately sized guidewire
Soft-Vu Pigtail Angiographic Catheters are being recalled because a manufacturing defect may prevent an appropriately sized guidewire from passing through the catheter hub.
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: FDA Class II recall where a manufacturing defect can obstruct guidewire passage during a procedure, a risk of harm with no injuries reported in the source.
Plain-English summary
The Soft-Vu Angiographic Catheter, Pigtail, Non-Braided, 4F x 65 cm, catalog number 10714002, is being recalled. The action covers 950 units in 95 boxes of 10 pouches.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter of the catheter hub. The FDA classified the action as Class II.
Distribution was worldwide, covering the United States nationwide and Austria, Australia, Belgium, Canada and other markets. The catheters are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog number, product number and UDI-DI in the recall notice, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;
- Manufacturer
- Angiodynamics, Inc.
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 (10)
- SOFT-VU PT 4F X 65CM 038 NB 10SH
- Catalog No.: 10714002
- Product/UPN No.: H787107140025 (Box)
- H787107140020 (Pouch)
- UDI-DI: 25051684007785(Box)
- 15051684007788(Pouch)
- Lot No.: A2525060
- A2525061
- A3625006
- A3625007
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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.
See all 20 products in this recall →Related recalls
Same manufacturer · Angiodynamics, Inc.
See all →- HighSoft-Vu Angiographic Catheter Pigtail Non-Braided Guidewire Passage Defect
FDA (Devices) · 2026-04-29
- HighAngiodynamics Soft-Vu Angiographic Catheter Cobra Non-Braided Recall
FDA (Devices) · 2026-04-29
- HighAccuVu Angiographic Catheter recall due to manufacturing defect
FDA (Devices) · 2026-04-29
- HighSoft-Vu Angiographic Catheter Berenstein Non-Braided Device Recall
FDA (Devices) · 2026-04-29
- HighAccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall
FDA (Devices) · 2026-04-29
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-09-09
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- HighU2 Total Knee System Femoral Valgus Adaptor Recall
FDA (Devices) · 2026-08-12
- HighUSTAR II Knee System Hinge Box Trial Recall
FDA (Devices) · 2026-08-12
- HighKnee Prosthesis Trial Recall for Manufacturing Defect
FDA (Devices) · 2026-08-12