223 results
·
42ms
·
Sources: EU EUDAMED, US FDA
ABBOTT ELECTROPHYSIOLOGY
FDA Adverse Event
Malfunction
·ABBOTT·Product code MTD·May 14, 2016
TENDRIL STS
FDA Adverse Event
Malfunction
·ABBOTT ELECTROPHYSIOLOGY·Product code NVN·October 16, 2022
TENDRIL MRI
FDA Adverse Event
Injury
·ABBOTT ELECTROPHYSIOLOGY·Product code NVN·October 28, 2019
FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
FDA Enforcement
Class III
·Terminated·Abbott Electrophysiology·September 9, 2015
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·April 21, 2009
ADVISOR HD GRID, SENSOR ENABLED
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.·Product code DRF·February 16, 2023
FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
FDA Recall
Terminated
·Abbott Electrophysiology·Product code MTD·August 12, 2015
INQUIRY¿ STEERABLE EP CATHETER
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.·Product code DRF·May 24, 2023
THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·May 2, 2018
TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE F-J
FDA Adverse Event
Death
·ST. JUDE MEDICAL·Product code OAE·November 4, 2024
THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·November 28, 2018
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC.·Product code LPB·December 20, 2019
DECANAV ELECTROPHYSIOLOGY CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC.·Product code DRF·December 20, 2019
CATHETER
FDA Adverse Event
Malfunction
·STRYKER SUSTAINABILITY SOLUTIONS·Product code NLH·November 21, 2024
INQUIRY¿ OPTIMA¿ DIAGNOSTIC CATHETER
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.·Product code DRF·September 9, 2019
SAFIRE¿ BLU¿ ABLATION CATHETER
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.·Product code OAD·September 9, 2019
THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC.·Product code LPB·June 28, 2019
FAST-CATH¿ CATH LOCK¿ HEMOSTASIS INTRODUCER
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL·Product code DYB·February 9, 2024
I-STAT ACTK (KAOLIN) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE CANADA LTD.·Product code JBP·May 31, 2011
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVY·December 4, 2025