AccuVu Angiographic Catheter recall due to manufacturing defect
Angiodynamics is recalling AccuVu Angiographic Catheters due to a manufacturing defect that may prevent a guidewire from passing through the catheter hub. The defect could interfere with proper device function during medical procedures.
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 classified this as Class II. The source does not report any illnesses or injuries, but the manufacturing defect creates a risk of harm by preventing proper guidewire passage during a medical procedure, which falls under the High category for risk-of-harm medical devices where injury has not yet been reported.
Plain-English summary
Angiodynamics, Inc. is recalling AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers (Catalog No. 13709005) worldwide. The affected devices contain a manufacturing defect that may prevent an appropriately sized guidewire from passing through the inner diameter of the catheter hub.
The defect could prevent the catheter from functioning as intended during angiographic procedures. Approximately 515 units (103 boxes) have been distributed in 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.
Healthcare providers and patients who have received or used these catheters should contact Angiodynamics for instructions on device replacement or return. Patients who have concerns about a procedure involving this device should consult their healthcare provider.
The recalled product
- Product
- AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch); Box Quantity: 5 pouches;
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- manufacturing-defect
- device-malfunction
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)
- ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM
- Catalog No.: 13709005
- Product/UPN No.: H787137090055 (Box)
- H787137090050 (Pouch)
- UDI-DI: 25051684005712(Box)
- 15051684005715(Pouch)
- Lot No.: A2725033
- A2725034
- A3525048
- A3525049
Distribution
Distributed nationwide across the United States.
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