Product Performance and Advisories Information for Healthcare Professionals

Overview

Medtronic is committed to providing the highest quality products. As part of our commitment, we share important information learned from the ongoing use of our products.

Product Advisories

We believe the content of product advisories will further patient safety. Review a list of recent product advisories below.

CARDIAC RHYTHM MANAGEMENT (CRM)

• Advisories are listed on the CRM Product Performance eSource. These products include pacemakers, defibrillators, cardiac resynchronization therapy devices, leads, and insertable cardiac monitors

Other Cardiovascular Portfolio Products

• February 2021: Urgent Medical Device Recall for Valiant Navion™ Thoracic Stent Graft System
  • May 2021: Update
• April 2020: HeartWare™ HVAD™ Outflow Graft and Strain Relief
• November 2018: Medtronic HeartWare™ HVAD™ System Battery Charger
• August 2018: HeartWare™ HVAD™ Controller Housing Integrity
• May 2018: HeartWare™ HVAD™ System Unexpected Power Source Switching: Initial Communication | Update Communication
• February 2018: BIOCAL™ Temperature Controller
• March 2017: Endurant Permeability
• November 2016: Affinity Fusion Oxygenator

DIABETES

• March 2021: Sensor Glucose Values with Use of Hydroxyurea Medications
• November 2020: Basal Rates In CareLink™ Reports
• November 2019: MiniMed™ 600 Series Pump Retainer Ring
• June 2019: MiniMed™ 508 Insulin Pump and MiniMed™ Paradigm™ Series Insulin Pumps
• May 2019: Guardian™ Connect – Potential Issue with Transmitter Battery Life
• October 2018: MiniMed™ 670G Insulin Infusion Pump – Potential Loss of Audio Issue, MiniMed™ 630G Insulin Infusion Pump – Potential Loss of Audio Issue
• August 2018: MiniMed™ Remote Controller (MMT-500 or MMT-503)
• February 2018: Medtronic MiniMed™ 600 Series Insulin Pump – Temporary Unresponsive Keypad
• September 2017: Medtronic MiniMed Infusion Sets – Potential Over-Delivery of Insulin
• July 2013: Medtronic Paradigm™ Reservoir Recall
• June 2013: Medtronic Paradigm™ Tubing Connectors
• March 2013: Potential Loose Drive Support Cap and Water Damage

Neuroscience

• September 2020: Pipeline™ Flex Embolization Device — Safety and Labeling Notification
• Deep Brain Stimulation Systems (including Activa neurostimulators)
• Spinal Cord Stimulation Systems (including Restore neurostimulators)
• Gastric Electrical Stimulation Systems (including the Enterra neurostimulator)
• Sacral Neuromodulation Systems (including InterStim neurostimulators)
• Targeted Drug Delivery Systems (including the SynchroMed II pump)

Product Performance Data

We believe in sharing updates with customers on a regular basis by showing the evolution of product performance over time. Review product reports and device information for the latest available data.

• Cardiac Rhythm Management
• Neuromodulation Product Performance
• October 2020: PERFORMANCE NOTE – HeartWare HVAD™ System Potential for Incorrect HVAD Driveline Cover Installation
• October 2020: PERFORMANCE NOTE – HeartWare HVAD™ System Potential For HVAD Controller Fault Alarms