Category

Cardiac Devices Recalls

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

958 recalls
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-...
Cardiac Devices·16,104 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications...
Cardiac Devices·6,111 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05...
Cardiac Devices·29,653 affected·Jul 27, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of ...
Cardiac Devices·1,239 affected·Jul 24, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic...
Cardiac Devices·110 affected·Jul 24, 2020
High RiskFDA
Philips North America, Llc
Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3...
Cardiac Devices·95,212 affected·Jul 16, 2020
High RiskFDA
Biosense Webster (israel), Ltd.
CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardi...
Cardiac Devices·0 affected·Jun 22, 2020
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional...
Cardiac Devices·4 affected·Jun 20, 2020
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional...
Cardiac Devices·5 affected·Jun 20, 2020
High RiskFDA
Hf Acquisition Co. Llc
STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support d...
Cardiac Devices·2 affected·Jun 5, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
Cardiac Devices·0 affected·May 22, 2020
High RiskFDA
Abbott
TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) -...
Cardiac Devices·84,104 affected·May 22, 2020
High RiskFDA
Ge Healthcare
The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional...
Cardiac Devices·221 affected·May 8, 2020
High RiskFDA
Defibtech, Llc
DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No. DCF-A2460EN DCF-A2463...
Cardiac Devices·860 affected·Apr 27, 2020
High RiskFDA
Defibtech, Llc
DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A101...
Cardiac Devices·860 affected·Apr 27, 2020
High RiskFDA
Philips North America, Llc
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination ...
Cardiac Devices·260 affected·Apr 27, 2020
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack ...
Cardiac Devices·352 affected·Apr 24, 2020
High RiskFDA
Biosense Webster
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV Hig...
Cardiac Devices·0 affected·Apr 22, 2020
High RiskFDA
Philips North America, Llc
Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical perso...
Cardiac Devices·130 affected·Apr 21, 2020
High RiskFDA
Philips North America, Llc
Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switch...
Cardiac Devices·21,683 affected·Apr 20, 2020
High RiskFDA
Philips North America, Llc
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical person...
Cardiac Devices·94,034 affected·Apr 13, 2020
High RiskFDA
Philips North America, Llc
HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Pro...
Cardiac Devices·8 affected·Apr 10, 2020
CriticalFDA
Heartware, Inc.
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
Cardiac Devices·20,147 affected·Apr 3, 2020
High RiskFDA
Physio-control, Inc.
LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The L...
Cardiac Devices·173,459 affected·Mar 20, 2020
High RiskFDA
Welch Allyn, Inc/mortara
Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.
Cardiac Devices·78,521 affected·Mar 18, 2020
High RiskFDA
Cardiac Assist, Inc
TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal c...
Cardiac Devices·2 affected·Mar 6, 2020
High RiskFDA
Cardiac Assist, Inc
TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorpor...
Cardiac Devices·15 affected·Mar 6, 2020
High RiskFDA
Cardiac Assist, Inc
TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique a...
Cardiac Devices·10 affected·Mar 6, 2020
High RiskFDA
Cardiac Assist, Inc
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal ci...
Cardiac Devices·38 affected·Mar 6, 2020
High RiskFDA
Canon Medical System, Usa, Inc.
Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system us...
Cardiac Devices·15 affected·Mar 3, 2020
High RiskFDA
Canon Medical System, Usa, Inc.
Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system us...
Cardiac Devices·46 affected·Mar 3, 2020
High RiskFDA
Canon Medical System, Usa, Inc.
Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system us...
Cardiac Devices·24 affected·Mar 3, 2020
CriticalFDA
Philips North America, Llc
HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, ...
Cardiac Devices·97,788 affected·Feb 26, 2020
High RiskFDA
Icu Medical, Inc.
The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619...
Cardiac Devices·123 affected·Feb 14, 2020
High RiskFDA
Deroyal Industries, Inc. Lafollette
Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This d...
Cardiac Devices·669 affected·Feb 6, 2020
CriticalFDA
Heartware, Inc.
HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refra...
Cardiac Devices·5,489 affected·Jan 23, 2020
CriticalFDA
Heartware, Inc.
HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advan...
Cardiac Devices·5,489 affected·Jan 23, 2020
High RiskFDA
St Jude Medical, Cardiac Rhythm Management Division
Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 ...
Cardiac Devices·256 affected·Jan 22, 2020
High RiskFDA
Philips North America, Llc
Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is inte...
Cardiac Devices·43 affected·Jan 14, 2020
High RiskFDA
Physio-control, Inc.
LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.
Cardiac Devices·29,952 affected·Dec 20, 2019
High RiskFDA
Physio-control, Inc.
LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
Cardiac Devices·705 affected·Dec 20, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY TRAY MNS10310 MEATOTOMY TRAY MNS10525 DELIV...
Cardiac Devices·0 affected·Dec 11, 2019
High RiskFDA
Thoratec Corp.
HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the He...
Cardiac Devices·13,871 affected·Dec 2, 2019
High RiskFDA
Philips North America, Llc
HeartStart XL+ Defibrillator/Monitor, Model 861290
Cardiac Devices·23,749 affected·Oct 16, 2019
High RiskFDA
Randox Laboratories, Limited
Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
Cardiac Devices·6,702 affected·Oct 4, 2019
High RiskFDA
Randox Laboratories, Limited
Randox Liquid Cardiac Controls Catalogue Number CQ5051
Cardiac Devices·6,208 affected·Oct 4, 2019
High RiskFDA
Philips North America, Llc
HeartStart XL+ Defibrillator/Monitor, Model 861290
Cardiac Devices·24,738 affected·Oct 3, 2019
High RiskFDA
Endotronix
myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform that provides the cl...
Cardiac Devices·58 affected·Sep 25, 2019