Category

Cardiac Devices Recalls

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

958 recalls
CriticalFDA
Boston Scientific Corporation
Model Number L101, ESSENTIO DR SL Pacemaker
Cardiac Devices·22,714 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L209 PROPONENT DR (VDD) SL Pacemaker
Cardiac Devices·3,146 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L221 PROPONENT DR EL Pacemaker
Cardiac Devices·3,592 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L131, ESSENTIO DR EL MRI Pacemaker
Cardiac Devices·190,088 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L121 ESSENTIO DR EL Pacemaker
Cardiac Devices·10,833 affected·Aug 20, 2025
High RiskFDA
Maquet Cardiovascular, Llc
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Cardiac Devices·126 affected·Aug 15, 2025
High RiskFDA
Maquet Cardiovascular, Llc
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
Cardiac Devices·28,331 affected·Aug 15, 2025
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model ...
Cardiac Devices·84 affected·Aug 11, 2025
CriticalFDA
Medtronic Perfusion Systems
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Cardiac Devices·41,200 affected·Aug 6, 2025
CriticalFDA
Medtronic Perfusion Systems
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
Cardiac Devices·25,261 affected·Aug 6, 2025
CriticalFDA
Medline Industries, Lp
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH ...
Cardiac Devices·7,913 affected·Jul 31, 2025
CriticalFDA
Medline Industries, Lp
Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic...
Cardiac Devices·7,913 affected·Jul 31, 2025
CriticalFDA
Boston Scientific Corporation
ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, ...
Cardiac Devices·247,702 affected·Jul 24, 2025
CriticalFDA
Boston Scientific Corporation
RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655...
Cardiac Devices·247,702 affected·Jul 24, 2025
High RiskFDA
Physio-control, Inc.
LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator ...
Cardiac Devices·1 affected·Jul 22, 2025
High RiskFDA
Physio-control, Inc.
LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022...
Cardiac Devices·4 affected·Jul 22, 2025
High RiskFDA
Physio-control, Inc.
LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 88507469895...
Cardiac Devices·3 affected·Jul 22, 2025
High RiskFDA
Insightra Medical Inc
Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25,...
Cardiac Devices·24,227 affected·Jul 19, 2025
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCU...
Cardiac Devices·31,506 affected·Jul 14, 2025
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; ...
Cardiac Devices·6,617 affected·Jul 14, 2025
High RiskFDA
Heartsine Technologies Ltd
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
Cardiac Devices·190,516 affected·Jun 30, 2025
CriticalFDA
Abiomed, Inc.
Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, ...
Cardiac Devices·11,031 affected·Jun 23, 2025
High RiskFDA
Boston Scientific Corporation
Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Use...
Cardiac Devices·14,724 affected·Jun 10, 2025
High RiskFDA
Boston Scientific Corporation
VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and co...
Cardiac Devices·14,724 affected·Jun 10, 2025
High RiskFDA
Boston Scientific Corporation
VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 4...
Cardiac Devices·14,724 affected·Jun 10, 2025
CriticalFDA
Edwards Lifesciences, Llc
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Prod...
Cardiac Devices·27,022 affected·May 14, 2025
High RiskFDA
Defibtech, Llc
Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (F...
Cardiac Devices·43 affected·Mar 18, 2025
High RiskFDA
Defibtech, Llc
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/E...
Cardiac Devices·13 affected·Mar 18, 2025
High RiskFDA
Defibtech, Llc
Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
Cardiac Devices·1 affected·Mar 18, 2025
High RiskFDA
Institut Georges Lopez
Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description...
Cardiac Devices·1,532 affected·Mar 13, 2025
CriticalFDA
Thoratec Llc
HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Le...
Cardiac Devices·1,661 affected·Mar 13, 2025
High RiskFDA
Zoll Medical Corporation
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerhe...
Cardiac Devices·7,221 affected·Feb 13, 2025
High RiskFDA
Zoll Medical Corporation
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C,...
Cardiac Devices·960 affected·Feb 13, 2025
High RiskFDA
Zoll Medical Corporation
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Ve...
Cardiac Devices·73 affected·Feb 13, 2025
High RiskFDA
Zoll Medical Corporation
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-...
Cardiac Devices·1,312 affected·Feb 13, 2025
High RiskFDA
Zoll Medical Corporation
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A,...
Cardiac Devices·2,268 affected·Feb 13, 2025
High RiskFDA
Zoll Medical Corporation
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version: NA Product Des...
Cardiac Devices·56,981 affected·Feb 13, 2025
High RiskFDA
Medline Industries, Lp - Northfield
namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 600...
Cardiac Devices·1,669 affected·Feb 12, 2025
High RiskFDA
Cardiofocus, Inc.
CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of a...
Cardiac Devices·833 affected·Feb 7, 2025
High RiskFDA
American Contract Systems Inc
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
Cardiac Devices·90 affected·Feb 6, 2025
High RiskFDA
St. Jude Medical
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Mode...
Cardiac Devices·193 affected·Feb 3, 2025
High RiskFDA
American Contract Systems, Inc.
Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/...
Cardiac Devices·460 affected·Jan 31, 2025
CriticalFDA
Boston Scientific Corporation
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL ...
Cardiac Devices·156,329 affected·Dec 12, 2024
CriticalFDA
Boston Scientific Corporation
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
Cardiac Devices·156,329 affected·Dec 12, 2024
High RiskFDA
Quidel Ortho
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Versi...
Cardiac Devices·1,541 affected·Dec 5, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA P...
Cardiac Devices·2,344 affected·Nov 21, 2024
High RiskFDA
Ge Oec Medical Systems, Inc
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide...
Cardiac Devices·78 affected·Nov 21, 2024
High RiskFDA
Med Michigan Holding Llc
SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove exce...
Cardiac Devices·109 affected·Nov 19, 2024