AccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall
Angiodynamics recalls AccuVu Angiographic Catheters due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The affected devices were distributed worldwide.
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: This is an FDA Class II recall of a medical device with a manufacturing defect that prevents proper function. The defect presents a risk of harm by obstructing guidewire passage during an angiographic procedure; however, no illnesses or injuries have been reported in the source text.
Plain-English summary
Angiodynamics, Inc. is recalling AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers (Catalog No. 13709704) due to a manufacturing defect. The affected devices contain a defect in the inner diameter (ID) of the catheter hub that may prevent an appropriately sized guidewire from passing through.
The recalled lot numbers are A3025039 and A3225033. A total of 500 units (100 boxes) have been affected. The devices were distributed worldwide to the United States and internationally 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.
If you have this product, contact Angiodynamics, Inc. for instructions on how to proceed. Do not use the affected devices and return them to the manufacturer or your supplier.
The recalled product
- Product
- AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); Box Quantity: 5 pouches;
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- device-defect
- functional-failure
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 (8)
- ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM
- Catalog No.: 13709704
- Product/UPN No.: H787137097045 (Box)
- H787137097040 (Pouch)
- UDI-DI: 25051684006030(Box)
- 15051684006033(Pouch)
- Lot No.: A3025039
- A3225033
Distribution
Distributed nationwide across the United States.
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