Category

Cardiac Devices Recalls

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

958 recalls
CriticalFDA
Conmed Corporation
ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CO...
Cardiac Devices·174,610 affected·Nov 6, 2014
CriticalFDA
Conmed Corporation
MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG...
Cardiac Devices·174,610 affected·Nov 6, 2014
CriticalFDA
Conmed Corporation
CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED I...
Cardiac Devices·174,610 affected·Nov 6, 2014
CriticalFDA
Conmed Corporation
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE ...
Cardiac Devices·174,610 affected·Nov 6, 2014
CriticalFDA
Conmed Corporation
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE...
Cardiac Devices·174,610 affected·Nov 6, 2014
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in comb...
Cardiac Devices·28 affected·Nov 5, 2014
High RiskFDA
Pulsion Medical Inc
Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usa...
Cardiac Devices·90 affected·Nov 4, 2014
High RiskFDA
Intuitive Surgical, Inc.
8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Cardiac Devices·509 affected·Nov 3, 2014
CriticalFDA
Customed, Inc
Open Heart Pack, catalog #900-2618 Used by medical staff to perform patient care procedures such as wound healing, suture removals, ir...
Cardiac Devices·106 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Open Heart Tray, Catalog number 900-1393. Used by medical staff to perform patient care procedures such as wound healing, suture remov...
Cardiac Devices·108 affected·Oct 8, 2014
CriticalFDA
Covidien Llc
Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected Part Number: 22660PC
Cardiac Devices·9,850 affected·Sep 18, 2014
CriticalFDA
Covidien Llc
Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R
Cardiac Devices·317,550 affected·Sep 18, 2014
High RiskFDA
Intuitive Surgical, Inc.
EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si Syste...
Cardiac Devices·1,034 affected·Sep 18, 2014
CriticalFDA
Covidien Llc
Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006
Cardiac Devices·133,930 affected·Sep 18, 2014
CriticalFDA
Covidien Llc
Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A
Cardiac Devices·151,210 affected·Sep 18, 2014
High RiskFDA
Boston Scientific Crm Corp
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not availabl...
Cardiac Devices·31,144 affected·Sep 17, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for s...
Cardiac Devices·44 affected·Sep 17, 2014
High RiskFDA
Bio-detek, Inc.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage...
Cardiac Devices·41 affected·Sep 16, 2014
High RiskFDA
Bio-detek, Inc.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 Product Usage: These MFE El...
Cardiac Devices·193 affected·Sep 16, 2014
High RiskFDA
Bio-detek, Inc.
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connec...
Cardiac Devices·237 affected·Sep 16, 2014
High RiskFDA
Intuitive Surgical, Inc.
ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: The Intuitive Surgical Endoscope Instru...
Cardiac Devices·75 affected·Sep 11, 2014
High RiskFDA
Bio-detek, Inc.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used ...
Cardiac Devices·100 affected·Aug 26, 2014
High RiskFDA
Bio-detek, Inc.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defi...
Cardiac Devices·198 affected·Aug 26, 2014
High RiskFDA
Maquet Cardiovascular, Llc
Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOS...
Cardiac Devices·16,532 affected·Aug 13, 2014
RecallFDA
Elitech Clinical Systems Sas
ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for ...
Cardiac Devices·878 affected·Aug 11, 2014
High RiskFDA
Heartsine Technologies, Limited
Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibri...
Cardiac Devices·3,245 affected·Jun 12, 2014
High RiskFDA
Hitachi Aloka Medical, Ltd.
Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) fo...
Cardiac Devices·0 affected·Jun 11, 2014
High RiskFDA
Nihon Kohden America Inc
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple pat...
Cardiac Devices·430 affected·Jun 3, 2014
CriticalFDA
Customed, Inc
Cirugia Cardiovascular Case Cart, c ode 900-1415A, contains: (1) CIRUGIA CARDIOVASCULAR .(INDUCCION) (1) CIRUGIA CARDIOVASCULAR (CIRUGI...
Cardiac Devices·7 affected·May 20, 2014
CriticalFDA
Customed, Inc
CIRUGIA CARDIOVASCULAR - CASE CART - (1) CIRUGIA CARDIOVASCULAR (PREPARACION) (1) CIRUGIA CARDIOVASCULAR (ENFERMERA CIRCULANTE) (1) CI...
Cardiac Devices·7 affected·May 20, 2014
CriticalFDA
Customed, Inc
OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF (5) DRAPE % ECONOMY 53" X 77" LIF ( 1) MAYO STAND ...
Cardiac Devices·6 affected·May 20, 2014
CriticalFDA
Customed, Inc
Open Heart Pack, code 900-2618, contains: (9) DRAPE 60" X 76" REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (6) TOWELS ABSORBENT...
Cardiac Devices·7 affected·May 20, 2014
High RiskFDA
Boston Scientific Corporation
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for...
Cardiac Devices·968 affected·May 15, 2014
High RiskFDA
Boston Scientific Corporation
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated f...
Cardiac Devices·968 affected·May 15, 2014
High RiskFDA
Boston Scientific Corporation
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. The BSC Controller and Accessories are indicated...
Cardiac Devices·968 affected·May 15, 2014
High RiskFDA
Boston Scientific Corporation
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated f...
Cardiac Devices·968 affected·May 15, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conju...
Cardiac Devices·16,337 affected·Apr 29, 2014
High RiskFDA
Smiths Medical Asd, Inc.
SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regul...
Cardiac Devices·2,120 affected·Apr 22, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]....
Cardiac Devices·101 affected·Apr 7, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic extern...
Cardiac Devices·9,872 affected·Apr 2, 2014
High RiskFDA
Ge Healthcare, Llc
GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
Cardiac Devices·447 affected·Mar 27, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine ...
Cardiac Devices·4,175 affected·Mar 19, 2014
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarm...
Cardiac Devices·4 affected·Mar 5, 2014
CriticalFDA
Thoratec Corporation
HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate II is a mechanical device that circulates blood throughout...
Cardiac Devices·36 affected·Mar 4, 2014
CriticalFDA
Thoratec Corporation
Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanical device that circulates blood th...
Cardiac Devices·7,436 affected·Mar 4, 2014
High RiskFDA
Philips Medical Systems North America Inc.
Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 ...
Cardiac Devices·1,267 affected·Feb 28, 2014
High RiskFDA
Biosense Webster, Inc.
PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D12820...
Cardiac Devices·15,672 affected·Feb 20, 2014
High RiskFDA
Philips Medical Systems, Inc.
M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricular tachycardia...
Cardiac Devices·220 affected·Feb 18, 2014