A610 Clinician Programmer Application for Deep Brain Stimulation… — Class II medical device recall Z-1368-2021
Ongoing recall by Medtronic Neuromodulation, reported 2021-04-14, distributed nationwide. There are two issues within this correction action: 1. Cycling Issue: When copying settings from a previously
| Recall number | Z-1368-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2021-03-09 |
| Classified | 2021-04-07 |
| Reported by FDA | 2021-04-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BG, BR, CA, CH, CZ, DE, DK, ES, FI, FR, GB, GR, HR, HU, IE, IL, IS, IT, JP, LT, LU, MT, MY, NL, NO, PL, PT, SA, SE, SI, SK, TH, TR |
| Quantity | 5,332 downloads |
| Reason classes | software |
| Model numbers | B35200 |
Product
A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.
Reason for recall
There are two issues within this correction action: 1. Cycling Issue: When copying settings from a previously used Activa device to a new Percept PC Implantable Neurostimulator (INS) using the "replacement" function of the A610 clinician programmer application, the cycling feature is not copied properly. 2. Log Fill Issue: When the Percept PC INS System Event log is full, the clinician programmer A610 Software application version 2.0.4584, 2.0.4594, 2.0.4605, or 3.0.1057 crashes when it attempts a reading of the last records in the log.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1368-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.