52 results
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64ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XLUNG KIT 230
FDA Adverse Event
Malfunction
·XENIOS AG·Product code QJZ·February 5, 2026
HLS SET
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·March 13, 2025
XLUNG KIT 230
FDA Adverse Event
Malfunction
·XENIOS AG·Product code QJZ·April 6, 2023
XLUNG KIT 230
FDA Adverse Event
Malfunction
·XENIOS AG·Product code QJZ·January 5, 2022
BIFURCATED TRANSPAC® IT MONITORING KIT W/03 ML FLUSH DEVICE, ADAPTOR ROTATING MA
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·April 12, 2019
CAPIOX FX ADVANCE HOLLOW FIBER OXYGENATOR W INTEGRATED AF W HARDSHELL RES.
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DTZ·March 17, 2026
BIFURCATED TRANSPAC® IT MONITORING KIT W/03 ML FLUSH DEVICE, ADAPTOR ROTATING MA
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·April 12, 2019
SORIN
FDA Adverse Event
Death
·LIVANOVA USA, INC.·Product code DWF·January 16, 2019
THORATEC CENTRIMAG VAD KIT, OUS
FDA Adverse Event
Death
·THORATEC SWITZERLAND GMBH·Product code OJE·December 22, 2017
TUBING SET
FDA Adverse Event
Death
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·March 20, 2025
TUBING SET
FDA Adverse Event
Death
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·March 18, 2025
THERMOGARD XP®
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code NCX·December 6, 2024
CAPIOX FX HOLLOW FIBER OXYGENATOR W INTEGRATED ARTERIAL FILTER W HARDSHELL RES.
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DTZ·December 23, 2025
PRESSURE MONITORING KIT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·November 14, 2018
CAPIOX FX HOLLOW FIBER OXYGENATOR W INTEGRATED ARTERIAL FILTER W HARDSHELL RES.
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DTZ·December 23, 2025
SUCTION AND ANTICOAGULANT LINE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code DWD·December 6, 2024
CS300
FDA Adverse Event
Death
·DATASCOPE CORP. - MAHWAH·Product code DSP·September 30, 2020
PERCEVAL SUTURELESS AORTIC HEART VALVE
FDA Adverse Event
Injury
·LIVANOVA CANADA CORP.·Product code LWR·December 9, 2020
EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPU·January 23, 2023
IMPELLA
FDA Adverse Event
Injury
·ABIOMED, INC. - 1220648·Product code OZD·March 11, 2026