Angiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
Angiodynamics is recalling the Soft-Vu Angiographic Catheter, Kumpe, Non-Braided due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
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 for a medical device with a functional defect that could impair its intended use during a clinical procedure, presenting a risk of harm. No reported injuries or illnesses are stated in the source, so the score does not exceed 3 per the rubric.
Plain-English summary
Angiodynamics, Inc. is recalling the Soft-Vu Angiographic Catheter, Kumpe, Non-Braided (Catalog No. 10714021) distributed worldwide including the United States and 20 other countries. The affected devices contain a manufacturing defect in the inner diameter of the catheter hub that may prevent an appropriately sized guidewire from passing through.
The defect creates a risk that medical professionals may be unable to use the catheter as intended. Specifically, 615 units (123 boxes) with lot numbers A2525059, A3725003, and A3725004 are affected.
Angiodynamics is requesting that healthcare providers and patients who have received this catheter contact the company or their healthcare provider for guidance on this recall. The device was distributed to healthcare facilities worldwide.
The recalled product
- Product
- Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box Quantity: 5 pouches;
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- device-blockage
- functional-defect
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 (9)
- SOFT-VU KMP 4F X 100CM 038 NB 0SH
- Catalog No.: 10714021
- Product/UPN No.: H787107140215 (Box)
- H787107140210 (Pouch)
- UDI-DI: 25051684007952(Box)
- 15051684007955(Pouch)
- Lot No.: A2525059
- A3725003
- A3725004
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModerateSilastic Brand Foley Catheters recalled due to surface stain
FDA (Devices) · 2026-05-27
- HighIntegris-Allura X-ray systems with degraded deaeration hoses recalled
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27