Angiodynamics vascular access catheter subject to voluntary recall
Angiodynamics has voluntarily recalled 285 units of DURAMAX STACKED TIP vascular access catheters (lots 5807195 and 5807196) used for hemodialysis. The specific reason for the recall is not disclosed in the FDA notice.
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 a Class II recall of vascular access catheters used in critical hemodialysis procedures. Such devices are inherently risk-of-harm products; any manufacturing defect could compromise patient safety. No illnesses or injuries are reported in the source, which prevents a higher score per the rubric.
Plain-English summary
Angiodynamics, Inc. has initiated a voluntary recall of 285 units of DURAMAX STACKED TIP 28 CM STRAIGHT vascular access catheters (UDI-DI: 25051684011935). The affected lot numbers are 5807195 and 5807196. These catheters are indicated for long-term vascular access in hemodialysis and apheresis procedures.
The recall was initiated on March 18, 2024, and reported to the FDA on May 15, 2024. It is classified as Class II. The specific defect or reason for this recall is not stated in the public FDA notice. The product was distributed in Virginia.
Patients currently using these catheters should contact their healthcare provider to determine if they are affected and to discuss appropriate medical management. Healthcare facilities should verify whether they have received any of the affected lot numbers and consult with the manufacturer regarding next steps.
The recalled product
- Product
- DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028195
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- Affected units
- 285
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 (2)
- UDI-DI: 25051684011935 Lot Numbers: 5807195
- 5807196
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 15 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 15 products in this recall →Related recalls
Same manufacturer · Angiodynamics, Inc.
See all →- HighSoft-Vu Angiographic Catheter Pigtail Non-Braided Guidewire Passage Defect
FDA (Devices) · 2026-04-29
- HighAngiodynamics Soft-Vu Angiographic Catheter Cobra Non-Braided Recall
FDA (Devices) · 2026-04-29
- HighAccuVu Angiographic Catheter recall due to manufacturing defect
FDA (Devices) · 2026-04-29
- HighSoft-Vu Angiographic Catheter Berenstein Non-Braided Device Recall
FDA (Devices) · 2026-04-29
- HighAccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall
FDA (Devices) · 2026-04-29
Same hazard · device defect
See all →- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22