Medtronic Restore Clinician Programmer App recalled for software reset message issue
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.
From the FDA notice · Read the official notice ↗ · All Medtronic recalls
What to do
- 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
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 7667 devices
- Illnesses reported
- None reported
- Manufactured in
- 7000 Central Ave Ne, N/A, Minneapolis, MN, United States
- Classification
- Class II
- Recall number
- Z-0996-2026
In the FDA's words
- Description
- 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 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. CP App: UDI-DI 00763000273668 all software versions prior to v.1.0.4489 are affected The implanted devices are not affected. Distribution: 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 quantity: 7667 devices
- 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.
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