Category

Cardiac Devices Recalls

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

958 recalls
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The HeartStart MRx is for use for ...
Cardiac Devices·6,583 affected·Feb 18, 2014
High RiskFDA
Philips Medical Systems, Inc.
HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC The HeartStart MRx is for ...
Cardiac Devices·39,128 affected·Feb 18, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
Cardiac Devices·3,541 affected·Feb 18, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 ser...
Cardiac Devices·33 affected·Feb 14, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feat...
Cardiac Devices·10,211 affected·Feb 13, 2014
High RiskFDA
Philips Medical Systems North America Inc.
Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered autom...
Cardiac Devices·251 affected·Feb 6, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC
Cardiac Devices·58,466 affected·Feb 4, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified ...
Cardiac Devices·7,157 affected·Jan 24, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor inten...
Cardiac Devices·40,239 affected·Dec 27, 2013
High RiskFDA
Ge Healthcare, Llc
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patien...
Cardiac Devices·2,516 affected·Dec 5, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitorin...
Cardiac Devices·1,948 affected·Dec 5, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CS...
Cardiac Devices·1,586 affected·Dec 5, 2013
High RiskFDA
Sorin Group Deutschland Gmbh
S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for pro...
Cardiac Devices·323 affected·Dec 4, 2013
CriticalFDA
Cryolife, Inc.
Pulmonary Hemi-Artery SG Used in heart surgery
Cardiac Devices·0 affected·Nov 22, 2013
RecallFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical In...
Cardiac Devices·3 affected·Nov 20, 2013
High RiskFDA
Medtronic Neurosurgery
Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebr...
Cardiac Devices·5 affected·Nov 18, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08...
Cardiac Devices·78 affected·Nov 13, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical to...
Cardiac Devices·464 affected·Oct 25, 2013
High RiskFDA
Ge Healthcare, Llc
GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging an...
Cardiac Devices·710 affected·Oct 11, 2013
High RiskFDA
Sorin Group Deutschland Gmbh
S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiop...
Cardiac Devices·84 affected·Sep 24, 2013
CriticalFDA
Baylis Medical Corp *
Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sh...
Cardiac Devices·370 affected·Sep 23, 2013
High RiskFDA
Maquet Cardiovascular, Llc
Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery thro...
Cardiac Devices·20 affected·Sep 20, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for ...
Cardiac Devices·1,625 affected·Sep 17, 2013
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX o...
Cardiac Devices·1,182 affected·Aug 15, 2013
CriticalFDA
Medline Industries, Inc.
HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline...
Cardiac Devices·160 affected·Aug 14, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high ...
Cardiac Devices·828 affected·Aug 13, 2013
High RiskFDA
Biosense Webster, Inc.
20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
Cardiac Devices·10 affected·Jun 19, 2013
High RiskFDA
Philips Healthcare Inc.
Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6...
Cardiac Devices·66,150 affected·Jun 19, 2013
High RiskFDA
Physio Control, Inc.
The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This softw...
Cardiac Devices·139 affected·Jun 12, 2013
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) The HeartStart MRx ...
Cardiac Devices·93 affected·Jun 7, 2013
High RiskFDA
Conmed Corporation
PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunctio...
Cardiac Devices·49,010 affected·May 3, 2013
High RiskFDA
Tz Medical Inc.
adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by tr...
Cardiac Devices·10,410 affected·Apr 30, 2013
High RiskFDA
Cardio Medical Products
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only M...
Cardiac Devices·657 affected·Apr 26, 2013
High RiskFDA
Heart Sync, Inc
Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation ...
Cardiac Devices·17,180 affected·Apr 26, 2013
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart...
Cardiac Devices·64,972 affected·Apr 10, 2013
High RiskFDA
Ge Healthcare, Llc
GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001...
Cardiac Devices·1,246 affected·Apr 9, 2013
High RiskFDA
Covidien Llc
Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing,...
Cardiac Devices·7,485 affected·Apr 8, 2013
High RiskFDA
Philips Healthcare Inc.
HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The Heart...
Cardiac Devices·64,972 affected·Apr 8, 2013
High RiskFDA
Transonic Systems Inc
HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. ...
Cardiac Devices·195 affected·Mar 28, 2013
CriticalFDA
Siemens Medical Solutions Usa, Inc.
Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ...
Cardiac Devices·120 affected·Mar 28, 2013
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system...
Cardiac Devices·6,117 affected·Mar 26, 2013
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system...
Cardiac Devices·5,472 affected·Mar 26, 2013
High RiskFDA
Agfa Corp.
IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured repo...
Cardiac Devices·2 affected·Mar 15, 2013
High RiskFDA
Vital Images, Inc.
Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and...
Cardiac Devices·102 affected·Mar 15, 2013
High RiskFDA
Arrow International Inc
Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Ang...
Cardiac Devices·99,627 affected·Mar 4, 2013
High RiskFDA
Philips Healthcare Inc.
Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qu...
Cardiac Devices·3,785 affected·Jan 28, 2013
High RiskFDA
Atricure Inc
Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency...
Cardiac Devices·5 affected·Jan 14, 2013
High RiskFDA
Greatbatch Medical
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath...
Cardiac Devices·10,201 affected·Nov 12, 2012