17 results
·
51ms
·
Sources: EU EUDAMED, US FDA
MIVI Q CATHETER
FDA Adverse Event
Malfunction
·MIVI NEUROSCIENCE, INC.·Product code DQY·August 18, 2023
MIVI Q CATHETER
FDA Adverse Event
Injury
·MIVI NEUROSCIENCE, INC.·Product code NRY·September 1, 2023
MODEL Q6-69145
FDA Adverse Event
Injury
·MIVI NEUROSCIENCE, INC.·Product code DQY·June 27, 2019
Q6 ASPIRATION CATHETER
FDA Adverse Event
Injury
·MIVI NEUROSCIENCE, INC.·Product code DQY·April 11, 2019
MIVI Q CATHETER
FDA Adverse Event
Malfunction
·MIVI NEUROSCIENCE, INC.·Product code DQY·January 16, 2023
MIVI Q CATHETER
FDA Adverse Event
Malfunction
·MIVI NEUROSCIENCE, INC.·Product code DQY·May 15, 2023
MIVI Q DISTAL ACCESS CATHETER
FDA Adverse Event
Injury
·MIVI NEUROSCIENCE, INC.·Product code DQY·November 9, 2022
MIVI Q CATHETER
FDA Adverse Event
Injury
·MIVI NEUROSCIENCE, INC.·Product code NRY·October 13, 2023
MIVI Q ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·MIVI NEUROSCIENCE, INC.·Product code DQY·January 26, 2022
MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
FDA Recall
Terminated
·Mivi Neuroscience Inc·Product code DQY·July 23, 2021
MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
FDA Recall
Terminated
·Mivi Neuroscience Inc·Product code DQY·July 23, 2021
MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
FDA Enforcement
Class II
·Terminated·Mivi Neuroscience Inc·September 15, 2021
MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
FDA Enforcement
Class II
·Terminated·Mivi Neuroscience Inc·September 15, 2021
Angionautix S.L.
Importer
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ICON (LR) Limited
Authorized representative
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Importer
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Duomed Belgium NV
Importer
🇧🇪 Belgium·62 Manufacturers