233 results
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85ms
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Sources: EU EUDAMED, US FDA
COAXIAL MICROINTRODUCER KIT MINI STICK MAX
FDA Adverse Event
Injury
·ANGIODYNAMICS, INC. / NAVILYST MEDICAL, INC.·Product code DRE·March 16, 2020
Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring
FDA Recall
Terminated
·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·June 8, 2016
Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.
FDA Recall
Terminated
·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·June 8, 2016
VASCULAR GUIDEWIRE
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code DQX·January 31, 2023
VASCULAR GUIDEWIRE
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code DQX·January 31, 2023
BIOFLO MIDLINE CATHETER
FDA Adverse Event
Injury
·ANGIODYNAMICS/NAVILYST MEDICAL INC. / ANGIODYNAMICS, INC.·Product code FOZ·August 24, 2020
ANGIODYNAMICS
FDA Adverse Event
Injury
·NAVILYST MEDICAL, INC. / ANGIODYNAMICS·Product code DRE·November 17, 2023
ANGIODYNAMICS
FDA Adverse Event
Injury
·NAVILYST MEDICAL, INC. / ANGIODYNAMICS·Product code DRE·November 17, 2023
BIOFLO POWER 3 FR SINGLE LUMEN POWER PICC
FDA Adverse Event
Malfunction
·NAVILYST MEDICAL, INC. (ANGIODYNAMICS)·Product code LJS·August 18, 2017
NAMIC STOPCOCK 400 PSI THREEWAY STOPCOCK W / FIXED MALE LUER LOCK
FDA Adverse Event
Malfunction
·NAVILYST MEDICAL / ANGIODYNAMICS, INC.·Product code DTL·January 15, 2020
NAMIC CLEARACIL
FDA Adverse Event
Injury
·NAVILYST MEDICAL INC./ ANGIODYNAMICS, INC.·Product code DQO·October 6, 2017
ANGIODYNAMICS MICROPUNCTURE KIT-MINI STICK MAX
FDA Adverse Event
Injury
·NAVILYST MEDICAL, INC./ANGIODYNAMICS, INC.·Product code DRE·July 24, 2024
BIOFLO MIDLINE CATHETER
FDA Adverse Event
Malfunction
·NAVILYST MEDICAL INC / ANGIODYNAMICS, INC.·Product code FOZ·July 9, 2020
MINI STICK MAX, COAXIAL MICROINTRODUCER KIT
FDA Adverse Event
Injury
·NAVILYST MEDICAL INC./ANGIODYNAMICS, INC·Product code DRE·October 21, 2020
SMART PORT CT ANGIO CATH
FDA Adverse Event
Malfunction
·NAVILYST MEDICAL, INC. / ANGIODYNAMICS, INC.·Product code LJT·November 1, 2023
ANGIODYNAMICS MINI STICK MAX
FDA Adverse Event
Injury
·NAVILYST MEDICAL INC. / ANGIODYNAMICS, INC.·Product code DRE·June 30, 2017
ANGIODYNAMICS MINI STICK MAX
FDA Adverse Event
Injury
·NAVILYST MEDICAL INC. / ANGIODYNAMICS, INC.·Product code DRE·January 6, 2021
MINI STICK MAX
FDA Adverse Event
Injury
·NAVILYST MEDICAL, INC. /ANGIODYNAMICS, INC.·Product code DRE·March 22, 2021
ANGIODYNAMICS MINI STICK MAX
FDA Adverse Event
Injury
·NAVILYST MEDICAL, INC. / ANGIODYNAMICS, INC.·Product code DRE·January 9, 2020
XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H965251260, Catalog No. 25-126 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.
FDA Recall
Terminated
·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·November 28, 2016