Category

Cardiac Devices Recalls

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

958 recalls
High RiskFDA
Customed, Inc
Catalog Number: 9002618 OPEN HEART SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures su...
Cardiac Devices·47 affected·Jan 7, 2016
CriticalFDA
Heartware, Inc.
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OU...
Cardiac Devices·18 affected·Jan 7, 2016
High RiskFDA
Boston Scientific Corporation
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing ...
Cardiac Devices·5 affected·Dec 10, 2015
High RiskFDA
Boston Scientific Corp
IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40; Catalog number: PM4500N4; Cardiac: The Int...
Cardiac Devices·1,556 affected·Nov 20, 2015
High RiskFDA
Boston Scientific Corp
IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40; Catalog number: PM4790N4; Cardiac: The ...
Cardiac Devices·1,556 affected·Nov 20, 2015
High RiskFDA
Vidco, Inc.
Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use ...
Cardiac Devices·59 affected·Nov 8, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS V3000; Model Number: 72243, 72244, 72245 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnosti...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and n...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagn...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS BH3000; Model Number: 72242 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular an...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS BH5000; Model Number: 72247 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular an...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular an...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnost...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiol...
Cardiac Devices·2 affected·Oct 26, 2015
High RiskFDA
Boston Scientific Corporation
Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
Cardiac Devices·3 affected·Sep 17, 2015
High RiskFDA
Biosense Webster, Inc.
SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel ...
Cardiac Devices·1,035 affected·Sep 10, 2015
High RiskFDA
Deroyal Industries Inc
DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Ope...
Cardiac Devices·836 affected·Sep 10, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844  ACUSON X700 Ultrasound System 10658846 - ACUSON ...
Cardiac Devices·4 affected·Sep 5, 2015
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE o...
Cardiac Devices·0 affected·Aug 31, 2015
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE ...
Cardiac Devices·355 affected·Aug 31, 2015
High RiskFDA
Edwards Lifesciences, Llc
ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged...
Cardiac Devices·759 affected·Aug 26, 2015
High RiskFDA
Boston Scientific Corporation
Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M63...
Cardiac Devices·29,169 affected·Aug 25, 2015
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
Cardiac Devices·153 affected·Aug 25, 2015
High RiskFDA
Boston Scientific Corporation
Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU...
Cardiac Devices·29,169 affected·Aug 25, 2015
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery.
Cardiac Devices·28 affected·Aug 25, 2015
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery.
Cardiac Devices·57 affected·Aug 25, 2015
CriticalFDA
Covidien Llc
MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC
Cardiac Devices·114,000 affected·Aug 19, 2015
CriticalFDA
Covidien Llc
Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022
Cardiac Devices·56,000 affected·Aug 19, 2015
CriticalFDA
Covidien Llc
MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC
Cardiac Devices·7,660 affected·Aug 19, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging ...
Cardiac Devices·2,039 affected·Aug 19, 2015
RecallFDA
Abbott Electrophysiology
FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only ...
Cardiac Devices·86 affected·Aug 12, 2015
CriticalFDA
Syncardia Systems Inc.
Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components o...
Cardiac Devices·56 affected·Aug 6, 2015
High RiskFDA
Medtronic Perfusion Systems
Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonar...
Cardiac Devices·221 affected·Jul 24, 2015
High RiskFDA
Customed, Inc
OPEN HEART TRAY CUSTOMED 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healin...
Cardiac Devices·37 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture ...
Cardiac Devices·106 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture ...
Cardiac Devices·56 affected·Jul 10, 2015
High RiskFDA
Biotronik, Inc.
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK...
Cardiac Devices·768 affected·Jun 30, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedur...
Cardiac Devices·0 affected·Jun 29, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures includi...
Cardiac Devices·0 affected·Jun 29, 2015
High RiskFDA
Hardy Diagnostics
Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusio...
Cardiac Devices·520 affected·Jun 26, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10...
Cardiac Devices·1,789 affected·Jun 25, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 104...
Cardiac Devices·629 affected·Jun 25, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified...
Cardiac Devices·13,168 affected·Jun 5, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: Th...
Cardiac Devices·573 affected·May 29, 2015
High RiskFDA
Edwards Lifesciences, Llc
Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardi...
Cardiac Devices·978 affected·May 5, 2015