Angiodynamics Recalls
133 recalls on record in the United States
Angiodynamics, Inc. recalls Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015)
Product was placed into distribution prior to completion of all required post sterilization release activities.
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Angiodynamics, Inc. recalls Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 9
The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.
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Angiodynamics, Inc. recalls Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 9
The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.
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Angiodynamics, Inc. recalls Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-6
The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.
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Angiodynamics, Inc. recalls Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-U
The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.
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Angiodynamics, Inc. recalls Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601,
The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.
View recall details →
Angiodynamics, Inc. recalls Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-6
The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.
View recall details →
Angiodynamics Inc. (Navilyst Medical Inc.) recalls XCELA PASV 5F DL 55CM MST-70 KIT PG, UPN H965457320, Catalog
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.
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Angiodynamics Inc. (Navilyst Medical Inc.) recalls XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog
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.
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Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H96
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.
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Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H9654587
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.
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Angiodynamics Inc. (Navilyst Medical Inc.) recalls XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H96525
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.
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Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H
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.
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Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, UPN H965458180,
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.
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Angiodynamics Inc. (Navilyst Medical Inc.) recalls Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA
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.
View recall details →
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330,
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.
View recall details →
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H9654588
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.
View recall details →
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H
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.
View recall details →
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H
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.
View recall details →
Angiodynamics Inc. (Navilyst Medical Inc.) recalls Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H9654587
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.
View recall details →
Angiodynamics Inc. (Navilyst Medical Inc.) recalls NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Ca
The product has the potential to be non-sterile as it was not packaged in accordance to specification.
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Angiodynamics Inc. (Navilyst Medical Inc.) recalls Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distri
The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured. The affected product is not soldered per specification, and may result in the device not properly conducting the ECG signal.
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Angiodynamics, Inc. recalls IsoLoc Short Profile Prostate Immobilization Treatment Ballo
Product is mislabeled with the incorrect fill volume.
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Angiodynamics, Inc. recalls AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Produ
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.
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Angiodynamics, Inc. recalls SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiog
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)
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Angiodynamics, Inc. recalls SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiog
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)
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Angiodynamics, Inc. recalls IsoLoc Prostate Immobilization Treatment Balloon Device Kit,
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 volume of 60cc/ml).
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Angiodynamics, Inc. recalls DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use i
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
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Angiodynamics, Inc. recalls DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
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Angiodynamics, Inc. recalls DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
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Showing 30 of 133 recalls. See all →