CLASS II ONGOING Device recall · Reported 7 Aug 2024 · FDA Enforcement Report
Soft-vu Kumpe 5F -Used for patients recalled by Angiodynamics
Angiodynamics is recalling Soft-vu Kumpe 5F -Used for patients in need of angiographic diagnosis, distributed nationwide in the US. The recall was initiated on 18 Jun 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2453-2024
- FDA event ID
- 94903
- Recalling firm
- Angiodynamics, Queensbury, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Jun 2024
- FDA classified
- 31 Jul 2024
- Reported
- 7 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 18 Jun 2024 | Recall initiated by company | |
| 31 Jul 2024 | Classified by FDA | +43 days |
| 7 Aug 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)
Product as listed by the FDA
SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)
Which lots are affected?
UPN: H787107327025 UDI-DI: 25051684009789 (Box) 15051684009782 (Pouch) Lot Number: A0424035
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 94903| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Soft-vu Kumpe 5F -Used for patients recalled by Angiodynamics | Angiodynamics | Labeling Errors | Nationwide |
More recalls from Angiodynamics
All 100| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Soft-Vu Angiographic Catheter, Headhunter , Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
| Device | CLASS II | Soft -Vu Angiographic Catheter, Kumpe, Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
| Device | CLASS II | Soft-Vu Angiographic Catheter, Cobra , Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
| Device | CLASS II | AccuVu Angiographic Catheter, Omni Flush, Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
| Device | CLASS II | Soft-Vu Angiographic Catheter, Cobra , Non-Braided recalled | Angiodynamics | Device Malfunction | Nationwide |
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