[pending] Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.
Pending LLM rewrite. Source: FDA_DEVICE Z-1859-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
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.
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.
- Category
- Medical Device — Devices
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.
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