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;
FDA Recall Z-1863-2026 · Posted 2026-04-17
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Recalling FirmAngiodynamics, Inc.
Recall StatusOpen, Classified
Product CodeDQO
Date Initiated2026-03-03
Product Quantity1030 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.
Firm Action
On March 3, 2026 URGENT VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers.
Actions to be taken:
IMMEDIATELY:
1. Stop using the devices subject to this recall and share the notification to all users of the deviceswithin your facility immediately.
2. Provide a copy of this recall notification to all sites or clinics to which you have distributed affectedproduct.
3. Remove any affected items/lots from your inventory (whether in labs, Central Supply, Shipping andReceiving or ANY other location).
4. Segregate this product in a secure location for return to AngioDynamics, Inc.
5. Package and Return the Recalled Product.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide 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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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