6 results
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50ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Malfunction
×
GORE TIPS SET, GORE® TIPS SHEATH, AND GORE TIPS NEEDLE
FDA Adverse Event
Malfunction
·CREGANNA MEDICAL·Product code DYB·January 24, 2023
GORE® DRYSEAL FLEX INTRODUCER SHEATH
FDA Adverse Event
Malfunction
·W. L. GORE & ASSOCIATES, INC.·Product code DYB·September 28, 2025
EMPIRA NC RX PTCA DILATATION CATHETER
FDA Adverse Event
Malfunction
·CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL·Product code LOX·September 5, 2018
EMPIRA NC RX PTCA DILATATION CATHETER
FDA Adverse Event
Malfunction
·CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL·Product code LOX·June 28, 2017
GORE® DRYSEAL FLEX INTRODUCER SHEATH
FDA Adverse Event
Malfunction
·W. L. GORE & ASSOCIATES, INC.·Product code DYB·February 10, 2026
EMPIRA RX PTCA DILATATION CATHETER
FDA Adverse Event
Malfunction
·CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL·Product code LOX·January 18, 2014