Category

Cardiac Devices Recalls

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

958 recalls
High RiskFDA
Biotronik Inc
BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and ve...
Cardiac Devices·0 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to provide ventricular tachycardia pacing...
Cardiac Devices·779 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachycardia pacing and v...
Cardiac Devices·499 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intended to provide ventricular tachycardia p...
Cardiac Devices·3,832 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and v...
Cardiac Devices·323 affected·Mar 8, 2021
High RiskFDA
Hitachi Medical Systems America Inc
Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagn...
Cardiac Devices·1 affected·Mar 1, 2021
High RiskFDA
Biosense Webster, Inc.
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)1084...
Cardiac Devices·0 affected·Feb 26, 2021
High RiskFDA
Biosense Webster, Inc.
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)1084...
Cardiac Devices·71,473 affected·Feb 26, 2021
High RiskFDA
Biosense Webster, Inc.
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)108...
Cardiac Devices·0 affected·Feb 26, 2021
High RiskFDA
Philips North America Llc
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Cardiac Devices·15 affected·Feb 9, 2021
High RiskFDA
Philips North America Llc
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Cardiac Devices·6 affected·Feb 9, 2021
High RiskFDA
Deroyal Industries Inc
Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs includin...
Cardiac Devices·1,084 affected·Jan 25, 2021
High RiskFDA
Deroyal Industries Inc
Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including stern...
Cardiac Devices·776 affected·Jan 25, 2021
High RiskFDA
Hardy Diagnostics
Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type:...
Cardiac Devices·820 affected·Dec 21, 2020
High RiskFDA
Ge Healthcare, Llc
Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Cardiac Devices·2 affected·Nov 23, 2020
High RiskFDA
Ge Healthcare, Llc
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography ...
Cardiac Devices·3 affected·Nov 23, 2020
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices ...
Cardiac Devices·58,438 affected·Nov 20, 2020
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are u...
Cardiac Devices·0 affected·Nov 20, 2020
High RiskFDA
Shimadzu Medical Systems
MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiogr...
Cardiac Devices·22 affected·Nov 18, 2020
High RiskFDA
Remote Diagnostic Technologies Ltd.
Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in th...
Cardiac Devices·175 affected·Nov 17, 2020
High RiskFDA
Medline Industries Inc
Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgeries including cardia...
Cardiac Devices·88 affected·Nov 13, 2020
High RiskFDA
Medline Industries Inc
Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdom...
Cardiac Devices·360 affected·Nov 13, 2020
High RiskFDA
Merit Medical Systems, Inc.
Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angi...
Cardiac Devices·80 affected·Nov 10, 2020
High RiskFDA
Cryolife, Inc.
CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the in...
Cardiac Devices·3 affected·Nov 10, 2020
High RiskFDA
Roi Cps Llc
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regar...
Cardiac Devices·17,700 affected·Nov 9, 2020
High RiskFDA
Icu Medical, Inc.
icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac out...
Cardiac Devices·220 affected·Nov 9, 2020
High RiskFDA
Canon Medical System, Usa, Inc.
CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and ...
Cardiac Devices·14 affected·Oct 8, 2020
High RiskFDA
Ge Healthcare, Llc
Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac a...
Cardiac Devices·64 affected·Sep 21, 2020
High RiskFDA
Medline Industries Inc
Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist ...
Cardiac Devices·60 affected·Sep 14, 2020
High RiskFDA
Philips North America, Llc
Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used...
Cardiac Devices·8,942 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist ...
Cardiac Devices·32 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consi...
Cardiac Devices·16 affected·Sep 14, 2020
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and ...
Cardiac Devices·2 affected·Aug 25, 2020
CriticalFDA
Medtronic Vascular
Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613...
Cardiac Devices·2,356 affected·Aug 25, 2020
CriticalFDA
Medtronic Vascular
Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 The...
Cardiac Devices·505 affected·Aug 25, 2020
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and ...
Cardiac Devices·100 affected·Aug 25, 2020
High RiskFDA
Irvine Biomedical Inc, A St. Jude Medical Co.
Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrop...
Cardiac Devices·15 affected·Aug 24, 2020
High RiskFDA
Irvine Biomedical Inc, A St. Jude Medical Co.
Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrop...
Cardiac Devices·40 affected·Aug 24, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-0...
Cardiac Devices·54,816 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndr...
Cardiac Devices·3,059 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications F...
Cardiac Devices·12,032 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296...
Cardiac Devices·31,529 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0...
Cardiac Devices·69,278 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 068...
Cardiac Devices·1,746 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications...
Cardiac Devices·3,542 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-02...
Cardiac Devices·1,275 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications...
Cardiac Devices·3,055 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For U...
Cardiac Devices·2,550 affected·Jul 27, 2020