Angiodynamics recalls
Angiodynamics appears in 100 official U.S. recall notices indexed by RecallRadar, most recently on 2026-04-29.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 100 |
|---|---|
| Published | 2013-06-05 to 2026-04-29 |
| By agency | FDA Device (100) |
| By classification | Class II (94), Class III (6) |
| By status | ongoing (59), terminated (41) |
| Distribution named in notices | AL, AR, AZ, CA, CT, DC, FL, GA, IL, IN, LA, MD, MI, MN, MO, NJ, NY, OH, OR, TN, TX, US, UT, VA, WA, WI |
Recalls
- Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - Soft-Vu Angiographic Catheter, Kumpe, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - Soft-Vu Angiographic Catheter, Pigtail, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - Soft -Vu Angiographic Catheter, Kumpe, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - Soft-Vu Angiographic Catheter, Berenstein, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - Soft-Vu Angiographic Catheter, Pigtail, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - Soft-Vu Angiographic Catheter, Kumpe, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - Soft-Vu Angiographic Catheter, Straight Art, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - Soft-Vu Angiographic Catheter, Berenstein, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - Soft-Vu Angiographic Catheter, Kumpe, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided
FDA Device · Class II · 2026-04-29 · Angiodynamics
Reason: The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. - IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit
FDA Device · Class II · 2025-03-26 · Angiodynamics
Reason: Product is mislabeled with the incorrect fill volume. - AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001
FDA Device · Class II · 2025-01-08 · Angiodynamics
Reason: Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode. - SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis
FDA Device · Class II · 2024-08-07 · Angiodynamics
Reason: 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) - SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis
FDA Device · Class II · 2024-08-07 · Angiodynamics
Reason: 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) - IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
FDA Device · Class II · 2024-07-10 · Angiodynamics
Reason: A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill v… - DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis
FDA Device · Class II · 2024-05-15 · Angiodynamics
Reason: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis
FDA Device · Class II · 2024-05-15 · Angiodynamics
Reason: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis
FDA Device · Class II · 2024-05-15 · Angiodynamics
Reason: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis
FDA Device · Class II · 2024-05-15 · Angiodynamics
Reason: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheres…
FDA Device · Class II · 2024-05-15 · Angiodynamics
Reason: XXX - DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis
FDA Device · Class II · 2024-05-15 · Angiodynamics
Reason: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheres…
FDA Device · Class II · 2024-05-15 · Angiodynamics
Reason: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheres…
FDA Device · Class II · 2024-05-15 · Angiodynamics
Reason: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis
FDA Device · Class II · 2024-05-15 · Angiodynamics
Reason: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Ap…
FDA Device · Class II · 2024-05-15 · Angiodynamics
Reason: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis
FDA Device · Class II · 2024-05-15 · Angiodynamics
Reason: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031
FDA Device · Class II · 2024-05-15 · Angiodynamics
Reason: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis
FDA Device · Class II · 2024-05-15 · Angiodynamics
Reason: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis
FDA Device · Class II · 2024-05-15 · Angiodynamics
Reason: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis
FDA Device · Class II · 2024-05-15 · Angiodynamics
Reason: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. - MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics
Reason: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the interna… - MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics
Reason: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the interna… - MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics
Reason: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the interna… - MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics
Reason: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the interna… - MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics
Reason: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the interna… - MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics
Reason: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the interna… - MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - C…
FDA Device · Class II · 2024-03-27 · Angiodynamics
Reason: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the interna… - MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics
Reason: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the interna… - MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics
Reason: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the interna… - MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics
Reason: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the interna…