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    MEDTRONIC BLOOD SYSTEMS, INC.

    FDA Adverse Event
    Injury ·MEDTRONIC BLOOD SYSTEMS, INC.·Product code FJK·July 21, 1994

    Medtronic Adjustable Valve, 6248VAL, Sterilized using irradiation. Medtronic, Inc. Minneapolis, MN 55432, USA. The Medtronic model 6248VAL adjustable valve is an accessory designed for use with Medtronic delivery systems to reduce blood loss during percutaneous catheter procedures. It consists of an adjustable valve and flush port.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code DTL·August 27, 2008

    Talent Captivia Stent Graft System - FreeFlow configurations only. Model numbers affected have the following designation: TFXXXXXXXXCP and TBXXXXXXXXCP. Medtronic Inc. Santa Rosa, CA 95403. The Talent Thoracic Stent Graft System is designed to treat thoracic aortic aneurysms using an endovascular approach. When placed within the target lesion, the stent graft provides an alternative conduit for blood flow within a patients vasculature by excluding the lesion from blood flow and pressure.

    FDA Recall
    Terminated ·Medtronic Vascular, Inc.·Product code MIH·February 21, 2012

    Medtronic HMS PLUS, Hemostasis Management System. Medtronic, Inc., Cardiovascular Division, Moundsview, MN 55112. A microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, activated clotting times and platelet function evaluations.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code JPA·March 8, 2010

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 25, 2022

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAH

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 21, 2022

    670G INSULIN PUMP MMT-1780KL

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 16, 2022

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 5, 2023

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·May 12, 2022

    PUMP MMT-1782K 670G V4.11 MM

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 7, 2023

    Medtronic Attain ACCESS 6218A, Left-heart delivery system. Sterilized. Manufactured in: Medtronic Ireland, Parkmore Business Park West, Galway, Ireland. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432 USA. The Medtronic Attain Access Model 6218A Left-heart delivery system is designed to facilitate lead implantation in the left heart, via the coronary sinus. The Left-heart delivery system features one guide wire to facilitate venous access, an adjustable valve to reduce blood loss during the implant procedure, two guide catheters for passing venogram balloon catheters and appropriate leads, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters, and a guide wire clip to help contain the guide wire in the sterile field.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code DQY·August 27, 2008

    Medtronic Attain LDS 6216A, Left-heart delivery system. Sterilized. Manufactured in: Medtronic Ireland, Parkmore Business Park West, Galway, Ireland. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432 USA. The Medtronic Attain LDS Model 6216A Left-heart delivery system is designed to facilitate lead implantation in the left heart, via the coronary sinus. The Left-heart delivery system features one guide wire to facilitate venous access, an adjustable valve to reduce blood loss during the implant procedure, two pre-shaped guide catheters for passing venogram balloon catheters and appropriate leads, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters, and a guide wire clip to help contain the guide wire in the sterile field.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code DQY·August 27, 2008

    OCTARAY MAPPING CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code MTD·July 7, 2025

    PUMP MMT-1880L MM770G BLE MG

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 10, 2022

    RESERVOIR 3ML MMT-332A

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 4, 2022

    670G INSULIN PUMP MMT-1780KL

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 25, 2022

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 4, 2023

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 19, 2022

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 20, 2024

    CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physicians as a therapy management accessory to: - read and store history and settings data supported insulin pump models and supported blood glucose meters - read and report user-programmable settings on supported pump models - read device data from the CareLink Online system - write new device data to the CareLink system - generate reports from the patient records for use in managing the patient's therapy. CareLink Clinical Medtronic CareLink MMT-7334 is a network based software system residing on a computer server platform connected to the Internet. The system is designed to upload patient data from Medtronic MiniMed insulin pumps and supported third-party blood glucose meters to the MMT-7334 central database via a client PC (Personal Computer), which connects to supported devices. The data contained in MMT-7334 is accessible to users using a standard browser, i.e. Microsoft Internet Explorer, on a PC that is connected to the Internet. The user may view and print various reports generated from the device data uploaded to MMT-7334, plus additional information provided by the user. The product does not provide any medical advice to patients or physicians. This is currently only intended to be used in Clinical Trials. Both products are CD ROMs.

    FDA Recall
    Terminated ·Medtronic MiniMed Inc.·Product code LZG·November 10, 2014