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FDA-Device2025-12-31Class IIPROCESSING DEFECT

Medtronic Restore Clinician Programmer App recalled for software reset message issue

Medtronic
OTHERNationwide distribution

Update Medtronic Restore Programmer App immediately

A software problem in the Medtronic Restore Clinician Programmer App (versions before v.1.0.4489) can cause a Device Reset message that cannot be cleared. In rare cases, this prevents the pain management device from resuming therapy, causing patients to experience pain symptoms again. The implanted devices themselves are not affected—only the programmer application used by clinicians.

  • Contact your Medtronic clinician or healthcare provider if you use a Restore pain management device
  • Update the Clinician Programmer App to version v.1.0.4489 or later
  • Do not attempt to reset your device yourself if you see this message
Hazard

Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.

Sold states
Worldwide distribution - US Nationwide and the countries of Argentina, Aruba, Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Malta, Mauritius, Mexico, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Poland, Portugal, Qatar, Reunion, Russia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay.
Affected count
7667 devices
Manufactured in
7000 Central Ave Ne, N/A, Minneapolis, MN, United States
Products
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0996-2026

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