February 26, 2016 – The Food and Drug Administration (FDA) announced a recall of 48 individual Medtronic ICDs and CRT-Ds, identified by the devices’ serial numbers.
For these 48 individual units, the Class I recall recommends that the physician and the patient strongly consider prophylactic device replacement for patients who have been implanted with one of the affected devices. HRS has communicated with Medtronic to verify that the problem has been addressed. On January 22, 2018, Medtronic notified all physicians whose patients had the devices.
Medtronic has identified a defect in the manufacturing process that caused an out of specification gas mixture inside the device that may prevent the device from delivering an electrical shock. One patient with an affected ICDexperienced sudden cardiac arrest and was revived via an external defibrillator. Medtronic determined that 48 individual devices made in a single manufacturing location and only distributed in the United States were affected.
Customers who have questions or need additional information or support regarding this recall should contact Medtronic Technical Services at 800-723-4636. Patients can contact Medtronic Patient Services at 800-551-5544 (Monday-Friday, 8am-5pm Central Time)
Background of Recall
For these 48 individual units, the Class I recall recommends that the physician and the patient strongly consider prophylactic device replacement for patients who have been implanted with one of the affected devices. HRS has communicated with Medtronic to verify that the problem has been addressed. On January 22, 2018, Medtronic notified all physicians whose patients had the devices.
Manufacturer Recommendations
Medtronic has identified a defect in the manufacturing process that caused an out of specification gas mixture inside the device that may prevent the device from delivering an electrical shock. One patient with an affected ICDexperienced sudden cardiac arrest and was revived via an external defibrillator.
Medtronic determined that 48 individual devices made in a single manufacturing location and only distributed in the United States were affected.
Reporting Contact
Customers who have questions or need additional information or support regarding this recall should contact Medtronic Technical Services at 800-723-4636. Patients can contact Medtronic Patient Services at 800-551-5544 (Monday-Friday, 8am-5pm Central Time).
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.
Topic
- Regulatory
- Regulatory Agencies
- U.S. Food and Drug Administration (FDA)
Resource Type
- Safety Alerts
Manufacturer
- Medtronic
Device Type
- ICDs & CRT-Ds
FDA Class
- Class I
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