12 results
·
33ms
·
Sources: EU EUDAMED, US FDA
Perfuze Ltd
Manufacturer
🇮🇪 Ireland
MILLIPEDE 070 ASPIRATION CATHETER
FDA Adverse Event
Injury
·PERFUZE LTD·Product code NRY·September 9, 2025
MILLIPEDE 088 ACCESS CATHETER
FDA Adverse Event
Injury
·PERFUZE LTD·Product code QJP·September 9, 2025
MILLIPEDE 070 ASPIRATION CATHETER
FDA Adverse Event
Injury
·PERFUZE LTD·Product code NRY·July 9, 2025
MILLIPEDE 088 ACCESS CATHETER
FDA Adverse Event
Injury
·PERFUZE LTD·Product code QJP·July 9, 2025
MILLIPEDE 088 ACCESS CATHETER
FDA Adverse Event
Injury
·PERFUZE LTD·Product code QJP·December 5, 2024
MILLIPEDE 088 ACCESS CATHETER
FDA Adverse Event
Injury
·PERFUZE LTD·Product code QJP·December 17, 2024
MILLIPEDE 070 ASPIRATION CATHETER
FDA Adverse Event
Injury
·PERFUZE LTD·Product code NRY·December 5, 2024
MILLIPEDE 070 ASPIRATION CATHETER
FDA Adverse Event
Injury
·PERFUZE LTD.·Product code NRY·December 17, 2024
MILLIPEDE 070 ASPIRATION CATHETER
FDA Adverse Event
Injury
·PERFUZE LTD·Product code NRY·May 28, 2025
MILLIPEDE 088 ACCESS CATHETER
FDA Adverse Event
Injury
·PERFUZE LTD·Product code QJP·May 28, 2025
Flextome Cutting Balloon Device Over-the-Wire Delivery System, Coronary Atherotomy System, Over-the-Wire Delivery System, Catalog No. CB0340006, 4.00mm, Sterile. Made in Ireland: Interventional Technologies Europe Ltd., A subsidiary of Boston Scientific Letterkenny, County Donegal, Republic of Ireland. US Customer Service 888-272-1001. The Flextome Cutting Balloon Device consists of a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Flextome Cutting Balloon Device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. This process, referred to as Atherotomy, allows dilation of the target lesion with less pressure. Indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code LOX·November 21, 2008