Category

Cardiac Devices Recalls

958 cardiac devices recalls on record from CPSC, FDA, and USDA.

958 recalls
High RiskFDA
Boston Scientific Corporation
VISIONIST CRT-P Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ESSENTIO DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ALTRUA 2 EL DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ACCOLADE MRI EL DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
PROPONENT DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
VALITUDE CRT-P Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
PROPONENT EL DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ACCOLADE MRI DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ACCOLADE MRI SR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ESSENTIO SR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ALTRUA 2 SR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
CriticalFDA
Physio-control, Inc.
LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, ...
Cardiac Devices·3,831 affected·Dec 4, 2017
High RiskFDA
Invivo Corporation
Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of ...
Cardiac Devices·1,040 affected·Nov 20, 2017
CriticalFDA
Physio-control, Inc.
LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrillation electrodes are used only with LIFEPAK ...
Cardiac Devices·14,219 affected·Oct 27, 2017
High RiskFDA
Fukuda Denshi Co., Ltd.
Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Pati...
Cardiac Devices·6,227 affected·Oct 16, 2017
High RiskFDA
Boston Scientific Corporation
VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with he...
Cardiac Devices·4 affected·Oct 4, 2017
High RiskFDA
Edwards Lifesciences, Llc
Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart...
Cardiac Devices·198 affected·Oct 2, 2017
CriticalFDA
Leonhard Lang Medizintechnik Gmbh
Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibri...
Cardiac Devices·8,249 affected·Aug 8, 2017
High RiskFDA
Zoll Medical Corporation
OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and ...
Cardiac Devices·3,400 affected·Aug 4, 2017
CriticalFDA
Edwards Lifesciences, Llc
Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edward...
Cardiac Devices·1,730 affected·Jul 21, 2017
High RiskFDA
Philips Electronics North America Corporation
ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as P...
Cardiac Devices·15,811 affected·Jul 17, 2017
CriticalFDA
Maquet Datascope Corp - Cardiac Assist Division
CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricula...
Cardiac Devices·14,547 affected·Jul 17, 2017
High RiskFDA
Ge Medical Systems Information Technologies, Inc.
CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM i...
Cardiac Devices·1,196 affected·Jul 13, 2017
CriticalFDA
Philips North America, Llc
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the term...
Cardiac Devices·71 affected·Jul 12, 2017
High RiskFDA
Boston Scientific Corporation
SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of l...
Cardiac Devices·12,450 affected·Jun 29, 2017
High RiskFDA
Avid Medical, Inc.
AVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06
Cardiac Devices·90 affected·Jun 22, 2017
High RiskFDA
Avid Medical, Inc.
AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code: VAMK016
Cardiac Devices·8 affected·Jun 22, 2017
High RiskFDA
Cyberonics, Inc
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use:...
Cardiac Devices·396 affected·Jun 13, 2017
High RiskFDA
Cyberonics, Inc
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. Product Usage: United States Indications for Use:...
Cardiac Devices·1,909 affected·Jun 13, 2017
High RiskFDA
Ge Medical Systems, Llc
Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to suppo...
Cardiac Devices·68 affected·May 11, 2017
High RiskFDA
Ge Medical Systems, Llc
Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic resonance scanner designed to support high re...
Cardiac Devices·68 affected·May 11, 2017
High RiskFDA
Ge Medical Systems, Llc
Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic resonance scanner designed to support high r...
Cardiac Devices·68 affected·May 11, 2017
High RiskFDA
Ge Medical Systems, Llc
1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a ...
Cardiac Devices·68 affected·May 11, 2017
High RiskFDA
Ge Medical Systems, Llc
1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa¿ HDx MR system...
Cardiac Devices·68 affected·May 11, 2017
High RiskFDA
Ge Medical Systems, Llc
SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner design...
Cardiac Devices·68 affected·May 11, 2017
High RiskFDA
Cardiotek Bv
CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, di...
Cardiac Devices·8 affected·Apr 13, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic c...
Cardiac Devices·4,095 affected·Apr 12, 2017
High RiskFDA
Datascope Corporation
SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number: 0684-00-0576-01U is a c...
Cardiac Devices·996 affected·Apr 12, 2017
High RiskFDA
Sorin Group Italia Srl - Crf
OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM...
Cardiac Devices·3,096 affected·Apr 11, 2017
High RiskFDA
Sorin Group Italia Srl - Crf
INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM ...
Cardiac Devices·37 affected·Apr 11, 2017
CriticalFDA
Oscor, Inc.
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. ...
Cardiac Devices·36,242 affected·Mar 31, 2017
CriticalFDA
Thoratec Corporation
HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic...
Cardiac Devices·24,077 affected·Mar 30, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc.
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer...
Cardiac Devices·2,045 affected·Mar 30, 2017
CriticalFDA
Thoratec Corporation
HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286 Intended to provide hemodynamic...
Cardiac Devices·24,077 affected·Mar 30, 2017
CriticalFDA
Heartware
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once a...
Cardiac Devices·9 affected·Mar 10, 2017
CriticalFDA
Philips North America, Llc
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3...
Cardiac Devices·97,794 affected·Feb 24, 2017
High RiskFDA
Datascope Corporation
Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are...
Cardiac Devices·21 affected·Feb 16, 2017
CriticalFDA
Heartware
HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantati...
Cardiac Devices·8,343 affected·Feb 3, 2017