Manufacturer

Angiodynamics, Inc.

64 recalls in our database name Angiodynamics, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–64 of 64

ModerateFDA (Devices)·Z-1335-2024·2024-03-27
Angiodynamics Guidewire Introducer Devices Recalled for Manufacturing Defects
Angiodynamics recalls MINI STICK MAX guidewire introducer devices due to manufacturing defects in the internal lumen that may prevent guidewire passage and delay surgical procedures.
Product
MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-750
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1336-2024·2024-03-27
FDA Recalls Vascular Guidewire Introducer Due to Manufacturing Defect
Angiodynamics is recalling 959 units of MINI STICK MAX guidewire introducers due to voids in the sheath hub that may prevent proper guidewire placement. Users may experience procedure delays and need to exchange equipment.
Product
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. Catalog Number: 45-751
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1338-2024·2024-03-27
Vascular Guidewire Introducer Sheath Recall Due to Manufacturing Defect
Angiodynamics is recalling certain MINI STICK MAX vascular guidewire introducer sheaths due to internal voids that may prevent guidewire passage during surgery, potentially causing procedural delays.
Product
MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-754
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1344-2024·2024-03-27
Guidewire Introducer Sheath with Manufacturing Defect Recalled by Angiodynamics
Angiodynamics is recalling MINI STICK MAX guidewire introducer sheaths due to manufacturing defects that may prevent guidewire passage. The defect may cause procedural delays requiring equipment exchange during vascular interventions.
Product
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. Catalog Number: 45-767
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1346-2024·2024-03-27
Guidewire Introducer Sheath from Angiodynamics Recalled for Manufacturing Defect
Angiodynamics is recalling 65 units of its MINI STICK MAX guidewire introducer sheath due to manufacturing defects that may prevent guidewires from passing through during surgical procedures.
Product
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. Catalog Number: 45-775
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1010-2024·2024-02-14
PulseSpray Infusion System O-Ring Defect May Cause Medication Leaks
Angiodynamics is recalling PulseSpray Infusion System devices due to a manufacturing defect in the rotating adaptor O-ring that may compromise seal integrity and cause medication to leak during infusion.
Product
PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1381-2023·2023-04-19
NanoKnife Surgical Probes Recalled Due to RFID Programming Error
Angiodynamics recalls NanoKnife 5-Probe Procedure Packs due to a programming error affecting RFID function. The probes may not be recognized by the NanoKnife generator, potentially delaying surgical procedures.
Product
NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0132-2023·2022-11-02
Vortex MP Port Titanium Recalled for Missing Printed Instructions
Angiodynamics is recalling 11 Vortex MP Port Titanium implantable ports because printed Instructions for Use were not shipped with the devices. Missing instructions could lead to improper implantation or post-operative care.
Product
Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous bloo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1819-2022·2022-10-05
VenaCure EVLT procedure kit fiber component fails dimensional specification
Angiodynamics is recalling 40 VenaCure EVLT procedure kit units with fiber components that fail dimensional specifications. The defect may damage the sheath, necessitating removal from the patient and potential additional surgical intervention.
Product
VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of varicose veins.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0073-2022·2021-10-13
AngioDynamics NanoKnife Disposable Probes Recalled for Programming Issue
AngioDynamics is recalling 37 NanoKnife Disposable Single Electrode Probes (Lot 5577754) due to a RFID programming issue that prevents the devices from being recognized by the NanoKnife generator.
Product
AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2439-2021·2021-09-15
Solero Generator PG requires software service for startup error
Angiodynamics is recalling 65 Solero Generator PG devices due to software Error 0001 that can occur during system startup. A software upgrade is required to reduce the incidence of this error.
Product
Solero Generator PG, Item No. H78712740000, Catalog No. 12740000
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2436-2021·2021-09-15
Solero MTA Generator requires software upgrade for startup error
Angiodynamics is recalling specific refurbished Solero MTA Generators due to Error 0001, which occurs during system startup. A software upgrade is required to reduce the error's frequency.
Product
Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2437-2021·2021-09-15
Solero MTA Generator Requires Software Upgrade to Reduce Startup Error
Angiodynamics is servicing specific Solero MTA Generator units to upgrade the software and reduce Error 0001 during startup. Affected units are identified by serial number.
Product
Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2438-2021·2021-09-15
Solero MTA Generator refurbished units require software servicing
Eight refurbished Solero MTA Generator units require software upgrades to reduce startup errors occurring in specific serial numbers.
Product
Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D
Category
Medical Device
Distribution
Distributed nationwide