Category

Cardiac Devices Recalls

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

958 recalls
High RiskFDA
Roi Cps Llc
Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
Cardiac Devices·322 affected·Mar 22, 2023
High RiskFDA
Defibtech, Llc
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Cardiac Devices·29 affected·Feb 14, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodyna...
Cardiac Devices·317 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodyna...
Cardiac Devices·36,875 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodyna...
Cardiac Devices·1,905 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemo...
Cardiac Devices·1,905 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemod...
Cardiac Devices·200 affected·Feb 7, 2023
High RiskFDA
St. Jude Medical
CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemod...
Cardiac Devices·3,177 affected·Feb 7, 2023
High RiskFDA
Heartsine Technologies Ltd
Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibri...
Cardiac Devices·13 affected·Feb 1, 2023
RecallFDA
Surepulse Medical Ltd
Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Cardiac Devices·0 affected·Jan 20, 2023
RecallFDA
Surepulse Medical Ltd
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Cardiac Devices·0 affected·Jan 20, 2023
High RiskFDA
Withings
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen satu...
Cardiac Devices·38,886 affected·Dec 19, 2022
High RiskFDA
Heartware, Inc.
HeartWare Model 1100
Cardiac Devices·45 affected·Nov 29, 2022
High RiskFDA
Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1104CA-CLIN
Cardiac Devices·6 affected·Nov 29, 2022
High RiskFDA
Heartware, Inc.
HeartWare Model 1101
Cardiac Devices·82 affected·Nov 29, 2022
High RiskFDA
Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1103
Cardiac Devices·5,704 affected·Nov 29, 2022
High RiskFDA
Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1104
Cardiac Devices·10,320 affected·Nov 29, 2022
CriticalFDA
Ge Medical Systems, Llc
Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, tes...
Cardiac Devices·5,145 affected·Nov 10, 2022
CriticalFDA
Ge Medical Systems, Llc
Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric;...
Cardiac Devices·1,400 affected·Nov 10, 2022
CriticalFDA
Ge Medical Systems, Llc
Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, tes...
Cardiac Devices·5,649 affected·Nov 10, 2022
CriticalFDA
Ge Medical Systems, Llc
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultra...
Cardiac Devices·7,931 affected·Nov 10, 2022
High RiskFDA
Deroyal Industries Inc
DeRoyal KIT HEART B PACK, REF 89-9042.07
Cardiac Devices·68 affected·Nov 3, 2022
High RiskFDA
Deroyal Industries Inc
DeRoyal PACEMAKER ICD PACK, REF 89-10902.01
Cardiac Devices·60 affected·Nov 3, 2022
High RiskFDA
Deroyal Industries Inc
DeRoyal HEART PACK, REF 89-8351.12
Cardiac Devices·102 affected·Nov 3, 2022
High RiskFDA
Deroyal Industries Inc
DeRoyal HEART PACK, REF 89-8351.13
Cardiac Devices·51 affected·Nov 3, 2022
High RiskFDA
Deroyal Industries Inc
DeRoyal CARDIAC LINEN PACK, REF 89-10543.02
Cardiac Devices·204 affected·Nov 3, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793
Cardiac Devices·18 affected·Nov 2, 2022
High RiskFDA
Syncardia Systems Llc
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Cardiac Devices·1,732 affected·Nov 2, 2022
High RiskFDA
Roi Cps Llc
¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit
Cardiac Devices·108 affected·Oct 20, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
Cardiac Devices·1 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
Cardiac Devices·1 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
Cardiac Devices·81 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
Cardiac Devices·0 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump
Cardiac Devices·0 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
Cardiac Devices·12 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump
Cardiac Devices·0 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
Cardiac Devices·15 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
Cardiac Devices·4 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
Cardiac Devices·1,394 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump
Cardiac Devices·4 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump
Cardiac Devices·48 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump
Cardiac Devices·0 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump
Cardiac Devices·0 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump
Cardiac Devices·0 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump
Cardiac Devices·112 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
Cardiac Devices·0 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump
Cardiac Devices·39 affected·Oct 17, 2022
High RiskFDA
Medical Action Industries, Inc. 306
B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)
Cardiac Devices·240 affected·Sep 15, 2022