Home / Brands / Angiodynamics Inc. (Navilyst Medical Inc.)
Angiodynamics Inc. (Navilyst Medical Inc.) Recalls
78 recalls on record · June 1, 2016 to October 6, 2021 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls RS 5F DL BIOFLO PASV, Catalog Number 60M181578
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls 5F DL BIOFLO PICC, Catalog Number 60M180592
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls RS 5F DL BIOFLO PASV, Catalog Number 60M161567
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls RS 5F DL BIOFLO PASV, Catalog Number 60M150373
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls 5F DL BIOFLO PASV, Catalog Number 60M141006
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls RS 5F DL BIOFLO PASV, Catalog Number 60M132324
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls RS 5F DL BIOFLO PICC, Catalog Number 60M071831
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls RS 5F DL XPP, Catalog Number 60M030393
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls RS TANDEM 5F DL XPP, Catalog Number 60M019881
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
June 20, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124
Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
April 25, 2018Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure M
Hazard: NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the device from being used, resulting in a minor delay in procedure.
December 20, 2017Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo
Hazard: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer. Greatbatch Medical determined that the products listed in their 11/11/2016 Recall Notification have the potential for the handles to detach from the sheath during use. NMI has confirmed that the affected sheaths, Greatbatch Model Number 10890-006, had been included in packaged Xcela and BioFlo PICC Kits.
December 20, 2017Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo
Hazard: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer. Greatbatch Medical determined that the products listed in their 11/11/2016 Recall Notification have the potential for the handles to detach from the sheath during use. NMI has confirmed that the affected sheaths, Greatbatch Model Number 10890-006, had been included in packaged Xcela and BioFlo PICC Kits.
December 20, 2017Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo
Hazard: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer. Greatbatch Medical determined that the products listed in their 11/11/2016 Recall Notification have the potential for the handles to detach from the sheath during use. NMI has confirmed that the affected sheaths, Greatbatch Model Number 10890-006, had been included in packaged Xcela and BioFlo PICC Kits.
December 20, 2017Medical DevicesFDA
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog No. 45-889 The Xcela with PASV, BioFlo P
Hazard: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer. Greatbatch Medical determined that the products listed in their 11/11/2016 Recall Notification have the potential for the handles to detach from the sheath during use. NMI has confirmed that the affected sheaths, Greatbatch Model Number 10890-006, had been included in packaged Xcela and BioFlo PICC Kits.