Medtronic Extends Voluntary Recall to Include 752 ICDs and CRT-D Units

Medtronic Extends Voluntary Recall to Include 752 ICDs and CRT-D Units Due to Lack of Electrical Shock Delivery

On March 16, Medtronic announced a voluntary recall affecting 752 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Implantable Cardioverter Defibrillators (ICDs). The affected devices may have undergone a specific sequence of manufacturing processes that could lead to an out-of-specification internal gas environment. Medtronic recommends that prophylactic device replacement be considered only for patients whose clinical history indicates prior need for high-voltage therapy, and/or those who are pacemaker-dependent. Medtronic has contacted those healthcare professionals who have one or more patients implanted with an affected device. The communication also includes a list of the affected models.

This notification extends the Food and Drug Administration (FDA) recall on February 26, 2018 of 48 Medtronic devices that were identified to have a defect in the manufacturing process that could lead to an out-of-specification internal gas environment. This may introduce a risk for internal arcing during high-voltage charging, resulting in immediate and permanent loss of device functionality, including pacing and high-voltage therapy. Within this lower-risk subset of 752 devices, if the device delivered the maximum number of shocks until battery depletion, Medtronic estimates 0.5% of these devices would experience arcing during high-voltage charging, with failure occurring within the first 2 high-voltage charges in 0.18% of the devices.

For additional information, healthcare professionals should contact their local Medtronic Representative or Medtronic Technical Services at 800-723-4636. Patients can call the Medtronic Patient Services at 800-551-5544.

Adverse reactions or quality problems experienced with the use of this product should be reported to the FDA MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail or by fax.
• Complete and submit a report online at www.fda.gov/medwatch/report.htm .
• Call 1-800-332-1088 to request a reporting form or download from www.fda.gov/MedWatch/getforms.htm . Forms may be mailed or faxed. Follow instructions on form.