223 results · 42ms · Sources: EU EUDAMED, US FDA

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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