52 results · 64ms · Sources: EU EUDAMED, 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