Category

Cardiac Devices Recalls

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

958 recalls
High RiskFDA
Heartware Inc
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refrac...
Cardiac Devices·3,747 affected·Apr 29, 2015
CriticalFDA
Heartware Inc
HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a br...
Cardiac Devices·3,747 affected·Apr 29, 2015
CriticalFDA
Heartware Inc
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usag...
Cardiac Devices·3,747 affected·Apr 29, 2015
CriticalFDA
Heartware Inc
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a ...
Cardiac Devices·3,747 affected·Apr 29, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for general surgery in hospital operating room
Cardiac Devices·138 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible...
Cardiac Devices·36 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800410001, Sterile, CV0479A - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible f...
Cardiac Devices·440 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 880327, Sterile, CV0758 - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible fi...
Cardiac Devices·54 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible fir...
Cardiac Devices·24 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room
Cardiac Devices·102 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800569001, Sterile, CV0659A - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible ...
Cardiac Devices·37 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible firm...
Cardiac Devices·199 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number 800565001, Sterile, CV0654A - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible ...
Cardiac Devices·57 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing cover light handle soft, RX. The responsible firm o...
Cardiac Devices·40 affected·Apr 22, 2015
High RiskFDA
Spacelabs Healthcare Inc
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Modu...
Cardiac Devices·1,999 affected·Apr 17, 2015
High RiskFDA
Biosense Webster, Inc.
SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Gen...
Cardiac Devices·115 affected·Mar 19, 2015
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use ...
Cardiac Devices·10,199 affected·Mar 5, 2015
High RiskFDA
Biosense Webster, Inc.
LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco C...
Cardiac Devices·464 affected·Feb 25, 2015
High RiskFDA
Transonic Systems Inc
Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical perso...
Cardiac Devices·21 affected·Feb 17, 2015
High RiskFDA
Intuitive Surgical, Inc.
Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive S...
Cardiac Devices·706 affected·Feb 16, 2015
CriticalFDA
Heartware Inc
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients ...
Cardiac Devices·4,845 affected·Jan 16, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediat...
Cardiac Devices·1 affected·Jan 16, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is intended for the ...
Cardiac Devices·230 affected·Jan 12, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600407061, REF/Catalog No. 60040706, STERILE, Rx ONLY --- For single use only. --- Device...
Cardiac Devices·489 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602207461, REF/Catalog No. 60220746, STERILE, Rx ONLY ---For single use only. --- Device L...
Cardiac Devices·17 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496007057101, REF/Catalog No. 600705710, STERILE, Rx ONLY --- For single use only. --- Devic...
Cardiac Devices·5 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602322341, REF/Catalog No. 60232234, STERILE, Rx ONLY --- For single use only. --- Device ...
Cardiac Devices·61 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601617931, REF/Catalog No. 60161793, STERILE, Rx ONLY ---For single use only. --- Device L...
Cardiac Devices·69 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART, UPN H7496006044121, REF/Catalog No. 600604412, STERILE, Rx ONLY ---For single use only. --- Device Lis...
Cardiac Devices·2,409 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog No. 600801020, STERILE, Rx ONLY ---For single use only. ---...
Cardiac Devices·105 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601506721, REF/Catalog No. 60150672, STERILE, Rx ONLY ---For single use only. --- Device L...
Cardiac Devices·5 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 60061801, STERILE, Rx ONLY --- For single use only. --- Device...
Cardiac Devices·562 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601605351, REF/Catalog No. 60160535, STERILE, Rx ONLY --- For single use only. --- Device ...
Cardiac Devices·2 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600125911, REF/Catalog No. 60012591, STERILE, Rx ONLY ---For single use only. --- Device L...
Cardiac Devices·2 affected·Jan 9, 2015
RecallFDA
Alivecor Sfo
Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monito...
Cardiac Devices·5,600 affected·Jan 9, 2015
High RiskFDA
Therasage, Llc.
FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Healt...
Cardiac Devices·0 affected·Dec 23, 2014
High RiskFDA
Philips Medical Systems, Inc.
HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage...
Cardiac Devices·75,693 affected·Dec 23, 2014
High RiskFDA
Hansen Medical Inc
Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the cathete...
Cardiac Devices·59 affected·Dec 4, 2014
CriticalFDA
Leonhard Lang Gmbh
GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: ...
Cardiac Devices·1,080 affected·Dec 3, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is dedicated angiography systems developed ...
Cardiac Devices·50 affected·Dec 3, 2014
High RiskFDA
St Jude Medical
TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows v...
Cardiac Devices·89 affected·Nov 25, 2014
High RiskFDA
Atricure Inc
Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablat...
Cardiac Devices·19,190 affected·Nov 21, 2014
High RiskFDA
Philips Medical Systems, Inc.
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Prod...
Cardiac Devices·74,499 affected·Nov 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The HeartStart MRx is for use for...
Cardiac Devices·27,918 affected·Nov 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Cardiac Devices·1,553 affected·Nov 19, 2014
CriticalFDA
Heart Sync, Inc.
ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medica...
Cardiac Devices·1,791 affected·Nov 11, 2014
CriticalFDA
Heart Sync, Inc.
ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical ...
Cardiac Devices·4,663 affected·Nov 11, 2014
CriticalFDA
Heart Sync, Inc.
ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips M...
Cardiac Devices·209 affected·Nov 11, 2014