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RecallWatchMedical Device Safety
Class IIOngoingZ-0996-2026

Medtronic Neuromodulation recalls Restore Clinician Programmer Application (CP App)

Medtronic NeuromodulationMinneapolis, MN, United StatesReported Dec 31, 2025 · 6 months ago
Legal News Analyst ·

Reason for recall

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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 GLBLSMSNG
    UDI-DI 00763000273668

What the firm is doing

On November 20, 2025, the firm notified customers via Urgent Medical Device Safety Notification letters. Medtronic has developed a new version of the A71100 CP App, v1.0.4489 or later, that contains a fix for this issue by ensuring the ability to clear a Device Reset message by pressing OK if the message appears. Customers should download v1.0.4489 or any later version at your earliest convenience.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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