CLASS II ONGOING Device recall · Reported 15 May 2024 · FDA Enforcement Report
Duramax Stacked Tip Str recalled by Angiodynamics
Angiodynamics is recalling Duramax Stacked Tip Str, distributed in Virginia. The recall was initiated on 18 Mar 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-1770-2024
- FDA event ID
- 94349
- Recalling firm
- Angiodynamics, Queensbury, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Mar 2024
- FDA classified
- 3 May 2024
- Reported
- 15 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 18 Mar 2024 | Recall initiated by company | |
| 3 May 2024 | Classified by FDA | +46 days |
| 15 May 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028055
Where it was distributed
VA
Questions about this recall
Why was it recalled?
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Which lots are affected?
UDI-DI: 25051684011850 Lot Numbers: 5809646
Where was it sold?
VA
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
14 other products · FDA event 94349This product is part of a recall event; the main page for the event is Duraflow 2 Straight Basic Kit Pg-Indicated for use recalled.
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 |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |