Restore Clinician Programmer Application recall: Software Issue
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B…
Why was Restore Clinician Programmer Application recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
CP App: UDI-DI 00763000273668 all software versions prior to v.1.0.4489 are affected The implanted devices are not affected.
- Product
- Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B…
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 7667 devices
- 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.
- Recall date
- December 31, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)