Recall Z-2427-2024 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Medtronic Neuromodulation
A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). Includes the below product descriptions: 1. ADAPTOR 64001 1X4 MVMT POCKET ADAPTOR, 2. ADAPTOR 64002 2X4 MVMT POCKET ADAPTOR, 3. INS 37602 Activa SC Neu
| Date | Jul 24, 2024 (initiated May 15, 2024) |
| Status | Open, Classified |
| Reason | Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility. |
| Root cause | Under Investigation by firm |
| Action | Recall notice sent to consignees beginning on 05/14/2024 via mail. Consignees are asked to confirm or revise the MRI eligibility display on the programmer, pass on the notice to all those who need to be aware within your organization and to other organizations on which this action has an impact, and confirm they have read and understand the customer actions within the letter and to return the signed confirmation form back to Medtronic. An UPDATE TO MEDICAL DEVICE CORRECTION RE: A610 Replacement workflow with DBS Pocket Adaptor affecting MRI eligibility display letter dated January 2025 was s |
| Quantity | 18,010 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Canary Islands, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Is |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.