Medtronic A610 Clinician Programmer pocket adaptors limited to head-only MRI
Medtronic recalled A610 Clinician Programmer software and pocket adaptors (Models 64001, 64002) due to MRI safety restrictions. Patients with these implants are limited to head-only MRI procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard involves a significant MRI safety restriction for implanted neuromodulation devices, which represents a risk-of-harm scenario where injury has not yet been reported, meeting the criteria for High severity.
Plain-English summary
Medtronic Neuromodulation has recalled the A610 Clinician Programmer software application and associated pocket adaptors (Models 64001 and 64002). The recall affects specific software versions (2.0.x, 3.0.x, and 4.0.x) and approximately 18,010 units distributed worldwide, including the United States and multiple other countries.
Patients who have been implanted with these pocket adaptors are restricted to head-only MRI procedures. Full-body MRI is not permitted for patients with these devices due to safety concerns. Healthcare providers and patients must ensure that any MRI imaging is limited to the head region.
Patients should inform their healthcare providers about this MRI restriction prior to any imaging procedures. If a patient requires MRI beyond the head, alternative diagnostic methods or additional consultation with Medtronic regarding device-specific safety information should be pursued.
The recalled product
- Product
- 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…
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 18,010
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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). 1. Model Number 64001
- GTIN (Serial Numbers): 00613994544940 (N733965
- N733969
- N753252
- N775354
- N776291
- N778120
- N782773)
- 00613994604477 (0212774778
- 0212775744
- 0212775759
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Medtronic Neuromodulation
See all →- ModerateMedtronic InterStim SureScan MRI Leads Recalled for Incompatible Selection
FDA (Devices) · 2026-10-28
- ModerateMedtronic InterStim Percutaneous Extensions Recalled for Incompatible Lead Selection
FDA (Devices) · 2026-10-28
- ModerateMedtronic 2x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- ModerateMedtronic 1x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
Similar recalls
- ModerateMedtronic Neuromodulation Clinician Programmer Application Software Anomaly Recall
FDA (Devices) · 2021-11-10
- HighMedtronic A610 Clinician Programmer Software Recall for Deep Brain Stimulation
FDA (Devices) · 2021-04-14
- HighMedtronic Intellis Clinician Programmer Application Software Malfunction Prevents Parameter Adjustment
FDA (Devices) · 2024-01-31
- ModerateMedtronic Restore Clinician Programmer software recalled for compatibility issue
FDA (Devices) · 2023-10-11
- ModerateMedtronic Intellis Spinal Cord Stimulator Software Recall
FDA (Devices) · 2021-01-20
- HighMedtronic Recalls DBS Pocket Adaptors Due to Conductor Wire Fracture Risk
FDA (Devices) · 2016-08-31