Category

Cardiac Devices Recalls

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

958 recalls
High RiskFDA
Shimadzu Medical Systems Usa Com
TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, pe...
Cardiac Devices·13 affected·Jan 14, 2019
High RiskFDA
Ge Healthcare, Llc
GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended f...
Cardiac Devices·1,897 affected·Dec 28, 2018
CriticalFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Cathete...
Cardiac Devices·875 affected·Dec 21, 2018
CriticalFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a dia...
Cardiac Devices·459 affected·Dec 21, 2018
CriticalFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a di...
Cardiac Devices·277 affected·Dec 21, 2018
CriticalFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a d...
Cardiac Devices·9 affected·Dec 21, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomogra...
Cardiac Devices·24 affected·Dec 19, 2018
RecallFDA
Boston Scientific Corporation
IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiof...
Cardiac Devices·1,282 affected·Nov 28, 2018
RecallFDA
Boston Scientific Corporation
Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofr...
Cardiac Devices·1,282 affected·Nov 28, 2018
RecallFDA
Boston Scientific Corporation
IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiof...
Cardiac Devices·1,282 affected·Nov 28, 2018
High RiskFDA
American Contract Systems, Inc.
Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP...
Cardiac Devices·51,152 affected·Nov 21, 2018
High RiskFDA
Heartware, Inc.
Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System ...
Cardiac Devices·2,031 affected·Nov 19, 2018
High RiskFDA
Ortho-clinical Diagnostics
VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-term...
Cardiac Devices·46,598 affected·Nov 1, 2018
CriticalFDA
Maquet Cardiovascular Us Sales, Llc
QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 ...
Cardiac Devices·490 affected·Oct 25, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system dev...
Cardiac Devices·54 affected·Oct 19, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system ...
Cardiac Devices·15 affected·Oct 19, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography sys...
Cardiac Devices·14 affected·Oct 19, 2018
High RiskFDA
Randox Laboratories Ltd.
Liquid Cardiac Control, CQ5053
Cardiac Devices·2,108 affected·Oct 2, 2018
CriticalFDA
Oscor, Inc.
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packa...
Cardiac Devices·36,688 affected·Sep 26, 2018
High RiskFDA
Sterilmed, Inc.
Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (1...
Cardiac Devices·218 affected·Sep 17, 2018
High RiskFDA
Livanova Usa Inc.
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-...
Cardiac Devices·6 affected·Sep 14, 2018
CriticalFDA
Ge Healthcare, Llc
GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of...
Cardiac Devices·103 affected·Sep 14, 2018
High RiskFDA
Boston Scientific Corporation
VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Cardiac Devices·0 affected·Sep 10, 2018
High RiskFDA
Boston Scientific Corporation
PROPONENT Pacemaker
Cardiac Devices·0 affected·Sep 10, 2018
High RiskFDA
Boston Scientific Corporation
ACCOLADE Pacemaker
Cardiac Devices·0 affected·Sep 10, 2018
High RiskFDA
Ge Healthcare Finland Oy
GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE...
Cardiac Devices·59,000 affected·Sep 4, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imagin...
Cardiac Devices·61 affected·Sep 4, 2018
High RiskFDA
Ge Healthcare Finland Oy
GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CAR...
Cardiac Devices·47,937 affected·Sep 4, 2018
High RiskFDA
Stryker Sustainability Solutions
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the...
Cardiac Devices·2 affected·Aug 23, 2018
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments, including scissors, s...
Cardiac Devices·23,064 affected·Aug 15, 2018
High RiskFDA
Philips North America Llc
Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
Cardiac Devices·181,894 affected·Aug 8, 2018
High RiskFDA
Philips Electronics North America Corporation
AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications i...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includi...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications ...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applica...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications incl...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
AIIura Xper F010 DR Table, System Code 722022 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 FD2O, System Code 722006 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications in...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS Allura 9 (biplane), System Code 722021 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 FD2O, System Code 722012 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications in...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging app...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applica...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper F010/10 DRTable, System Code 722019 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 FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applica...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications i...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper F020 DR Table, System Code 722015 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 F010 DR Table, System Code 722014 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applic...
Cardiac Devices·5,115 affected·Jul 16, 2018