The Recall Desk
HighFDA (Devices)·Z-2427-2024·Announced 2024-07-31

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.

What this means for you

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 descripti
Manufacturer
Medtronic Neuromodulation
Category
Medical Device — Neuromodulation / Deep Brain Stimulation
Hazard
  • mri-restriction
  • implant-incompatibility

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 category