Category

Cardiac Devices Recalls

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

958 recalls
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22 AXIOM Artis, Artis zee / zeego and Artis Q...
Cardiac Devices·11,111 affected·Jul 13, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography...
Cardiac Devices·11,111 affected·Jul 13, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of de...
Cardiac Devices·11,111 affected·Jul 13, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 1028095...
Cardiac Devices·51 affected·Jul 7, 2016
High RiskFDA
Spacelabs Healthcare Inc
91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Op...
Cardiac Devices·3,801 affected·Jul 1, 2016
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multip...
Cardiac Devices·360 affected·Jun 23, 2016
High RiskFDA
Terumo Cardiovascular Systems Corporation
Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm wa...
Cardiac Devices·6,412 affected·Jun 8, 2016
CriticalFDA
Heartware, Inc.
HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at ...
Cardiac Devices·4,235 affected·Jun 8, 2016
High RiskFDA
Terumo Cardiovascular Systems Corporation
HX2" Temperature Management Systems; The Terumo¿ HX2" Temperature Management System provides temperature control of two independent w...
Cardiac Devices·6,412 affected·Jun 8, 2016
High RiskFDA
Datascope Corporation
Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be ...
Cardiac Devices·17 affected·May 9, 2016
High RiskFDA
Medtronic Navigation, Inc.
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visuala...
Cardiac Devices·120 affected·May 9, 2016
High RiskFDA
Stryker Sustainability Solutions
Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardi...
Cardiac Devices·18 affected·Apr 28, 2016
RecallFDA
Biomerieux France Chemin De L'or
VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS fami...
Cardiac Devices·229 affected·Apr 15, 2016
High RiskFDA
Philips Electronics North America Corporation
HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibril...
Cardiac Devices·17 affected·Apr 14, 2016
High RiskFDA
Biosense Webster, Inc.
Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pent...
Cardiac Devices·13,912 affected·Apr 14, 2016
High RiskFDA
Biosense Webster, Inc.
Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster ...
Cardiac Devices·59,672 affected·Apr 14, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physio...
Cardiac Devices·24 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and rec...
Cardiac Devices·2 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures...
Cardiac Devices·219 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterizati...
Cardiac Devices·242 affected·Mar 28, 2016
High RiskFDA
Philips Ultrasound, Inc.
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for u...
Cardiac Devices·11,085 affected·Mar 28, 2016
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control S...
Cardiac Devices·248 affected·Mar 16, 2016
High RiskFDA
Merit Medical Systems, Inc.
Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when pa...
Cardiac Devices·25 affected·Mar 15, 2016
High RiskFDA
Ge Medical Systems, Llc
SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolut...
Cardiac Devices·16 affected·Mar 1, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidime...
Cardiac Devices·3,204 affected·Feb 26, 2016
High RiskFDA
Medtronic Inc.
Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
Cardiac Devices·189,009 affected·Feb 23, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and...
Cardiac Devices·1,757 affected·Feb 19, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neu...
Cardiac Devices·1,757 affected·Feb 19, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems ...
Cardiac Devices·986 affected·Feb 18, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography sy...
Cardiac Devices·986 affected·Feb 18, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems ...
Cardiac Devices·986 affected·Feb 18, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems ...
Cardiac Devices·986 affected·Feb 18, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems ...
Cardiac Devices·986 affected·Feb 18, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems ...
Cardiac Devices·986 affected·Feb 18, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems ...
Cardiac Devices·986 affected·Feb 18, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems ...
Cardiac Devices·986 affected·Feb 18, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems ...
Cardiac Devices·986 affected·Feb 18, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems ...
Cardiac Devices·986 affected·Feb 18, 2016
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accur...
Cardiac Devices·542 affected·Feb 16, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is a mobile X-ray system designed to provide X-...
Cardiac Devices·4 affected·Feb 16, 2016
CriticalFDA
Arrow International, Inc., Division Of Teleflex Medical Inc.
Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in t...
Cardiac Devices·13,405 affected·Feb 10, 2016
CriticalFDA
Arrow International, Inc., Division Of Teleflex Medical Inc.
Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the a...
Cardiac Devices·13,405 affected·Feb 10, 2016
CriticalFDA
Arrow International, Inc., Division Of Teleflex Medical Inc.
Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the a...
Cardiac Devices·13,405 affected·Feb 10, 2016
CriticalFDA
Arrow International, Inc., Division Of Teleflex Medical Inc.
RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the a...
Cardiac Devices·13,405 affected·Feb 10, 2016
CriticalFDA
Arrow International, Inc., Division Of Teleflex Medical Inc.
UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in t...
Cardiac Devices·13,405 affected·Feb 10, 2016
CriticalFDA
Arrow International, Inc., Division Of Teleflex Medical Inc.
FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby ba...
Cardiac Devices·13,405 affected·Feb 10, 2016
High RiskFDA
Physio-control, Inc.
LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software versio...
Cardiac Devices·44,798 affected·Jan 27, 2016
RecallFDA
Sorin Group Usa, Inc.
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: H...
Cardiac Devices·6,859 affected·Jan 19, 2016