SOFT-VU KUMPE Catheters Recalled for Mislabeled Inner Pouch
Angiodynamics is recalling SOFT-VU KUMPE 5F X 65CM angiographic catheters (595 boxes nationwide) because inner pouch labels may show information for a different catheter model while shelf-box labels are correct.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is a labeling discrepancy that could cause misuse, but no actual harm has been documented.
Plain-English summary
Angiodynamics, Inc. is recalling SOFT-VU KUMPE 5F X 65CM catheters, which are used for angiographic diagnosis. The recall affects 595 boxes distributed nationwide.
The issue is mislabeling of the inner pouch. While the shelf-box labeling correctly identifies the product and catheter length, the inner pouch label may contain information for a different catheter model with a different length. This discrepancy could lead healthcare providers to select or use an incorrect catheter length.
Healthcare providers and facilities with affected units should verify inner pouch labeling before use. Products with conflicting or questionable labeling should not be used. Contact Angiodynamics, Inc. for instructions regarding affected product disposition.
The recalled product
- Product
- SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- Affected units
- 595
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
Same manufacturer · Angiodynamics, Inc.
See all →- HighAngiodynamics Soft-Vu Angiographic Catheter Cobra Non-Braided Recall
FDA (Devices) · 2026-04-29
- HighSoft-Vu Angiographic Catheter Cobra Non-Braided Manufacturing Defect
FDA (Devices) · 2026-04-29
- HighAccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall
FDA (Devices) · 2026-04-29
- HighSoft-Vu Angiographic Catheter Pigtail Non-Braided Guidewire Passage Defect
FDA (Devices) · 2026-04-29
- HighSoft-Vu Angiographic Catheter Berenstein Non-Braided Device Recall
FDA (Devices) · 2026-04-29
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- HighAngiodynamics Soft-Vu Angiographic Catheter Kumpe Recall
FDA (Devices) · 2026-04-29
- HighSoft-Vu Angiographic Catheter, Kumpe, Non-Braided manufacturing defect
FDA (Devices) · 2026-04-29
- ModerateAngioDynamics Recalls Soft-Vu Angiographic Catheters Due to Mislabeled Pouches
FDA (Devices) · 2012-08-15
- HighSoft-Vu Angiographic Catheter Kumpe Non-Braided manufacturing defect recall
FDA (Devices) · 2026-04-29
- HighAngiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
FDA (Devices) · 2026-04-29
- SevereSoft-Vu Angiographic Catheter Recalled Due to Manufacturing Defect
FDA (Devices) · 2026-04-29