Category

Cardiac Devices Recalls

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

958 recalls
High RiskFDA
Philips North America Llc
Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
Cardiac Devices·96 affected·Sep 10, 2019
High RiskFDA
Philips North America Llc
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Cardiac Devices·44 affected·Sep 10, 2019
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
Cardiac Devices·22,244 affected·Aug 6, 2019
High RiskFDA
Philips North America, Llc
Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15...
Cardiac Devices·834 affected·Jul 16, 2019
High RiskFDA
Philips North America, Llc
HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillato...
Cardiac Devices·2 affected·Jul 16, 2019
CriticalFDA
Edwards Lifesciences, Llc
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
Cardiac Devices·1,754 affected·Jul 9, 2019
CriticalFDA
Edwards Lifesciences, Llc
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
Cardiac Devices·2,208 affected·Jul 9, 2019
CriticalFDA
St Jude Medical Inc.
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585
Cardiac Devices·15 affected·Jun 20, 2019
High RiskFDA
Zoll Medical Corporation
ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibr...
Cardiac Devices·1,969 affected·Jun 12, 2019
High RiskFDA
Philips North America, Llc
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536...
Cardiac Devices·97,794 affected·Jun 7, 2019
High RiskFDA
Getinge Us Sales Llc
PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in...
Cardiac Devices·7 affected·Jun 5, 2019
High RiskFDA
Cardiac Science Corporation
Powerheart¿ G5 Automatic AED
Cardiac Devices·5 affected·Jun 4, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT ...
Cardiac Devices·70 affected·Jun 3, 2019
High RiskFDA
Medline Industries, Inc.
Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP C...
Cardiac Devices·14,550 affected·May 30, 2019
High RiskFDA
Siemens Healthcare Diagnostics Inc
Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in...
Cardiac Devices·2,312 affected·May 29, 2019
RecallFDA
Cardiocommand Inc.
CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Tempo...
Cardiac Devices·5 affected·May 10, 2019
High RiskFDA
Philips Ultrasound Inc
Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ...
Cardiac Devices·3,146 affected·Apr 29, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350
Cardiac Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge- (1) Material: 701067350R01 BEQ-TOP 5208 ECC Small-Cardiac (2) material: 701067350R02 BEQ-TOP 5208 ECC Small-Cardiac
Cardiac Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge- (1) Material :701067370R01 BO-TOP 38803 OPEN HEART PACK W (2) Material: 701067370R02 BO-TOP 38803 OPEN HEART PACK W (3...
Cardiac Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BO-TOP 14605 OPEN HEART WITHOU Material: 701067372
Cardiac Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery Material:709000004
Cardiac Devices·0 affected·Apr 18, 2019
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material: 709000133
Cardiac Devices·0 affected·Apr 18, 2019
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H78770010600...
Cardiac Devices·10,580 affected·Apr 17, 2019
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030...
Cardiac Devices·1,846 affected·Apr 17, 2019
RecallFDA
Abbott Laboratories
ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the ...
Cardiac Devices·3 affected·Apr 9, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for ...
Cardiac Devices·459 affected·Apr 9, 2019
RecallFDA
Abbott Laboratories
ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the esti...
Cardiac Devices·2 affected·Apr 9, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography system...
Cardiac Devices·459 affected·Apr 9, 2019
High RiskFDA
Thoratec Corp.
Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device...
Cardiac Devices·149 affected·Mar 30, 2019
CriticalFDA
Edwards Lifesciences, Llc
Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The Miller balloon atrio...
Cardiac Devices·1,564 affected·Mar 28, 2019
CriticalFDA
Edwards Lifesciences, Llc
Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation ...
Cardiac Devices·1,093 affected·Mar 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system ...
Cardiac Devices·2 affected·Mar 22, 2019
High RiskFDA
Ge Healthcare, Llc
NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Me...
Cardiac Devices·16 affected·Mar 20, 2019
High RiskFDA
Response Biomedical Corp.
Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #0703...
Cardiac Devices·543 affected·Mar 15, 2019
High RiskFDA
Randox Laboratories Ltd.
Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
Cardiac Devices·11,420 affected·Mar 11, 2019
RecallFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is desig...
Cardiac Devices·2,917 affected·Mar 4, 2019
High RiskFDA
Thoratec Corp.
Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assi...
Cardiac Devices·650 affected·Mar 1, 2019
High RiskFDA
Draegar Medical Systems, Inc.
Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, ped...
Cardiac Devices·10,699 affected·Feb 8, 2019
CriticalFDA
Physio-control Inc
LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care respo...
Cardiac Devices·13,005 affected·Feb 1, 2019
CriticalFDA
Physio-control Inc
LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardi...
Cardiac Devices·682 affected·Feb 1, 2019
CriticalFDA
Cook Inc.
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and in...
Cardiac Devices·100 affected·Feb 1, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, ...
Cardiac Devices·70 affected·Jan 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA1...
Cardiac Devices·1,384 affected·Jan 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10...
Cardiac Devices·2,262 affected·Jan 28, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B,...
Cardiac Devices·1,869 affected·Jan 28, 2019
High RiskFDA
Ge Healthcare, Llc
Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography app...
Cardiac Devices·857 affected·Jan 19, 2019
High RiskFDA
Shimadzu Medical Systems Usa Com
BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the hear...
Cardiac Devices·8 affected·Jan 14, 2019