Category

Cardiac Devices Recalls

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

958 recalls
RecallFDA
Deroyal Industries Inc
DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
Cardiac Devices·849 affected·Jan 25, 2017
High RiskFDA
Medtronic Neurosurgery
Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used i...
Cardiac Devices·315,997 affected·Jan 17, 2017
High RiskFDA
Physio-control, Inc.
LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical area...
Cardiac Devices·7 affected·Jan 16, 2017
High RiskFDA
Physio-control, Inc.
LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indo...
Cardiac Devices·2,584 affected·Jan 16, 2017
CriticalFDA
Physio-control, Inc.
The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR...
Cardiac Devices·133,330 affected·Jan 13, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn
Cardiac Devices·274 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU
Cardiac Devices·26 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU
Cardiac Devices·28 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn
Cardiac Devices·117 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 880327009, Sterile, CV0758I - Open Heart A&B - OSU
Cardiac Devices·32 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 880327008, Sterile, CV0758H - Open Heart A&B - OSU
Cardiac Devices·16 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU
Cardiac Devices·30 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn
Cardiac Devices·228 affected·Jan 9, 2017
High RiskFDA
Ge Oec Medical Systems, Inc
OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during dia...
Cardiac Devices·0 affected·Dec 19, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSON SC2000 ultrasou...
Cardiac Devices·33 affected·Nov 7, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for singl...
Cardiac Devices·4,657 affected·Nov 1, 2016
CriticalFDA
Syncardia Systems Inc.
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
Cardiac Devices·5 affected·Oct 21, 2016
High RiskFDA
Alere San Diego, Inc.
Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control mate...
Cardiac Devices·513 affected·Oct 12, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of catheters to any of ...
Cardiac Devices·33 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facilitate the introdu...
Cardiac Devices·991 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduc...
Cardiac Devices·55 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the ...
Cardiac Devices·110 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introd...
Cardiac Devices·1,729 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of t...
Cardiac Devices·21 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the...
Cardiac Devices·74 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 Is designed to facilitate the introduction of catheters to any of the...
Cardiac Devices·70 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Catalog # 990079-055-000 Is designed to facilitate the introdu...
Cardiac Devices·59 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000 Is designed to facilitate the introduct...
Cardiac Devices·45 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 Is designed to facilitate the introduction of catheters to any of the h...
Cardiac Devices·30 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the h...
Cardiac Devices·156 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is designed to facilitate the introduction of catheters to any of ...
Cardiac Devices·26 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed to facilitate the introdu...
Cardiac Devices·186 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of...
Cardiac Devices·34 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the h...
Cardiac Devices·991 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is designed to facilitate the introduction of catheters to any of the...
Cardiac Devices·124 affected·Oct 5, 2016
High RiskFDA
Icu Medical, Inc.
OPEN HEART KIT W/03ML FLUSH DEVICE FOR CUMBERLAND COUNTY HOSP., Item No. 46094-08 The Transpac Disposable Straight Pressure Transducer (...
Cardiac Devices·20 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP., Item No. 46097-36 The Transpac Disposable Straight Pressure Transduc...
Cardiac Devices·70 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac¿ IV Disposable Transducer, Item ...
Cardiac Devices·70 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
Right Heart Cath Lab Kit w/2 Port "OFF" Manifold (600 psi), 72" Spike Set, Transpac¿ IV and 48" HP Tubing, Item No. 46100-87 The Transpa...
Cardiac Devices·40 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
CVP ARTERIAL LINE KIT WITH 03ML FLUSH DEVICE FOR KANSAS HEART HOSP, Item No. 46091-04 The Transpac Disposable Straight Pressure Transduc...
Cardiac Devices·100 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
CARDIAC CATHETERIZATION WASTE MANAGEMENT SYSTEM LEFT HEART KIT, Item No. 46073-14 The Transpac Disposable Straight Pressure Transducer (...
Cardiac Devices·560 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
OPEN HEART KIT WITH 03ML FLUSH DEVICE FOR FLETCHER ALLEN HEALTH CARE, Item No. 46063-77 The Transpac Disposable Straight Pressure Transd...
Cardiac Devices·120 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
RIGHT HEART CATH LAB KIT FOR BAPTIST MEM. HOSP., Item No. 46071-40 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ext...
Cardiac Devices·20 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
RIGHT HEART KIT FOR NC BAPTIST HOSPITAL, Item No. 46066-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascul...
Cardiac Devices·125 affected·Sep 27, 2016
High RiskFDA
Icu Medical, Inc.
LEFT HEART KIT, Item No. AG8052-NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer t...
Cardiac Devices·80 affected·Sep 27, 2016
High RiskFDA
Atricure, Inc.
COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 7...
Cardiac Devices·5,263 affected·Sep 22, 2016
High RiskFDA
Randox Laboratories
The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocy...
Cardiac Devices·2,817 affected·Sep 16, 2016
High RiskFDA
Biosense Webster, Inc.
CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CA...
Cardiac Devices·338 affected·Aug 15, 2016