Category

Cardiac Devices Recalls

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

958 recalls
High RiskFDA
Philips Electronics North America Corporation
Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging appl...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applic...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imagin...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients...
Cardiac Devices·96,324 affected·Jul 13, 2018
High RiskFDA
Hitachi Medical Systems America Inc
Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Comput...
Cardiac Devices·1 affected·Jun 29, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of dedicated angiography system...
Cardiac Devices·605 affected·Jun 22, 2018
High RiskFDA
Boston Scientific Corporation
Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R...
Cardiac Devices·793 affected·Jun 20, 2018
High RiskFDA
Shimadzu Medical Systems Usa Com
TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, periph...
Cardiac Devices·1 affected·Jun 15, 2018
High RiskFDA
Edwards Lifesciences, Llc
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Cardiac Devices·1 affected·Jun 11, 2018
CriticalFDA
Ge Medical Systems, Llc
Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Numbe...
Cardiac Devices·516 affected·Jun 6, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01...
Cardiac Devices·32 affected·May 21, 2018
High RiskFDA
Arrow International Inc
Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location info...
Cardiac Devices·2,070 affected·May 17, 2018
High RiskFDA
Arrow International Inc
VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous c...
Cardiac Devices·2,070 affected·May 17, 2018
High RiskFDA
Arrow International Inc
VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous cath...
Cardiac Devices·2,070 affected·May 17, 2018
High RiskFDA
Cryolife, Inc.
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Cardiac Devices·1 affected·May 14, 2018
High RiskFDA
Philips Electronics North America Corporation
HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearab...
Cardiac Devices·5 affected·May 3, 2018
CriticalFDA
Heartware
Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 140...
Cardiac Devices·175,878 affected·May 2, 2018
High RiskFDA
Ge Healthcare Japan Corporation
GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. ...
Cardiac Devices·92 affected·Apr 27, 2018
High RiskFDA
St Jude Medical Inc.
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring...
Cardiac Devices·986 affected·Apr 16, 2018
High RiskFDA
St Jude Medical, Cardiac Rhythm Management Division
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name o...
Cardiac Devices·2,906 affected·Apr 13, 2018
High RiskFDA
Ge Medical Systems, Llc
MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (pr...
Cardiac Devices·54 affected·Mar 30, 2018
High RiskFDA
Stryker Sustainability Solutions
Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: T...
Cardiac Devices·2,722 affected·Mar 29, 2018
CriticalFDA
Medtronic Navigation, Inc.
Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator System 3mm T...
Cardiac Devices·1,283 affected·Mar 23, 2018
High RiskFDA
Ge Medical Systems Ultrasound & Primary Care Diagnostics, Ll
GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. ...
Cardiac Devices·12,426 affected·Mar 22, 2018
High RiskFDA
Ge Medical Systems Ultrasound & Primary Care Diagnostics, Ll
GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specializ...
Cardiac Devices·12,426 affected·Mar 22, 2018
High RiskFDA
Ge Medical Systems Ultrasound & Primary Care Diagnostics, Ll
GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fet...
Cardiac Devices·12,426 affected·Mar 22, 2018
High RiskFDA
Ge Medical Systems Ultrasound & Primary Care Diagnostics, Ll
GE Vivid E95 ultrasound system Product The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abd...
Cardiac Devices·12,426 affected·Mar 22, 2018
High RiskFDA
Ge Medical Systems Ultrasound & Primary Care Diagnostics, Ll
GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. I...
Cardiac Devices·12,426 affected·Mar 22, 2018
High RiskFDA
Invivo Corporation
PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (internation...
Cardiac Devices·4,375 affected·Mar 14, 2018
High RiskFDA
Philips Electronics North America Corp.
Philips HeartStart FRx AED.
Cardiac Devices·1 affected·Mar 14, 2018
High RiskFDA
Intuitive Surgical, Inc.
da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surg...
Cardiac Devices·108 affected·Mar 7, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker
Cardiac Devices·2,549 affected·Mar 5, 2018
High RiskFDA
Conmed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in e...
Cardiac Devices·18,720 affected·Feb 23, 2018
High RiskFDA
Conmed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pac...
Cardiac Devices·18,720 affected·Feb 23, 2018
High RiskFDA
Conmed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external p...
Cardiac Devices·18,720 affected·Feb 23, 2018
High RiskFDA
Conmed Corporation
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibr...
Cardiac Devices·18,720 affected·Feb 23, 2018
High RiskFDA
Datascope Corporation
Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide co...
Cardiac Devices·655 affected·Feb 21, 2018
High RiskFDA
Datascope Corporation
Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide co...
Cardiac Devices·2,714 affected·Feb 21, 2018
High RiskFDA
Datascope Corporation
Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counte...
Cardiac Devices·12,744 affected·Feb 21, 2018
High RiskFDA
Transonic Systems Inc
Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extrac...
Cardiac Devices·6,044 affected·Feb 15, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Cardiac Devices·1,301 affected·Feb 15, 2018
RecallFDA
Philips Electronics North America Corporation
HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel train...
Cardiac Devices·4,315 affected·Feb 7, 2018
High RiskFDA
Philips Electronics North America Corporation
Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated...
Cardiac Devices·28,094 affected·Jan 29, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interv...
Cardiac Devices·16 affected·Jan 12, 2018
High RiskFDA
Stryker Sustainability Solutions
Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The R...
Cardiac Devices·170 affected·Jan 2, 2018
High RiskFDA
Boston Scientific Corporation
PROPONENT SR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ACCOLADE DR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017
High RiskFDA
Boston Scientific Corporation
ACCOLADE SR Pacemaker
Cardiac Devices·0 affected·Dec 7, 2017