Soft-Vu Angiographic Catheter Pigtail Non-Braided Guidewire Passage Defect
Angiodynamics is recalling Soft-Vu Angiographic Catheter (Pigtail, Non-Braided) due to a manufacturing defect that may prevent a guidewire from passing through the catheter hub's inner diameter.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II medical device recall involving a structural defect that could impair the device's intended function during an interventional procedure. No illnesses or injuries are reported in the source text, but the defect creates a risk of harm to patients requiring angiographic catheterization, meeting the High severity criterion.
Plain-English summary
Angiodynamics, Inc. is recalling the Soft-Vu Angiographic Catheter, Pigtail, Non-Braided (Catalog No. 10707103; UPNs H787107071035 for box and H787107071030 for pouch; Lot No. A3325043). The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter of the catheter hub.
A total of 450 units (45 boxes) have been distributed worldwide, including throughout the United States and to Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, and Thailand. Customers who have received affected devices should contact Angiodynamics, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;
- 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 (7)
- SOFT-VU PT 4F X 100CM 035 NB 10SH
- Catalog No.: 10707103
- Product/UPN No.: H787107071035 (Box)
- H787107071030 (Pouch)
- UDI-DI: 25051684006177 (Box)
- 15051684006170 (Pouch)
- Lot No.: A3325043
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
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