SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with

FDA device recall Z-0772-2025 · posted 2024-12-27 · Open, Classified

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Software issues were identified in application version 2.x.

Action taken

An URGENT: MEDICAL DEVICE CORRECTION notification letter dated November 2024 was sent to customers. Actions Share this notice with all those who need to be aware of this issue within your organization and maintain a copy of this notice in your records. Please complete and return the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information. The form may be emailed to neuro.quality@medtronic.com. Additional Information Medtronic is actively working on a permanent solution and will inform you as soon as it becomes available. Medtronic is communicating this information to the appropriate regulatory agencies. Adverse events or quality problems experienced with this product should be reported to Medtronic and the FDA MedWatch Adverse Event Reporting program via: Medtronic email at RS.NeuAdverseEventReporting@Medtronic.com or Medtronic Technical Services at 1-800-707-0933 weekdays 7:00 AM 6:00 PM CT. ***Update January 2026*** An URGENT: MEDICAL DEVICE CORRECTION notification letter dated January 2026 was sent to customers. The purpose of this letter is to inform you that a new version of the Model A810 SynchroMed Clinician Programmer Application (CP App), v2.0.3320, is now available for installation. This update addresses previously communicated software issues associated with earlier versions used for the Model 8637 SynchroMed II and Model 8667 SynchroMed III infusion pumps. These issues were initially communicated to you in the letter enclosed from November 2024. The new version of the A810 CP App resolves these issues. Customer Actions: " Download and install A810 CP App v2.0.3320 at your earliest convenience and contact your local Medtronic representative if you have any questions related to the update. " Sign and return the Confirmation Form enclosed with this letter, acknowledging that you have received this information. The form may be emailed to neuro.quality@medtronic.com. Retain a copy of this lette

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LKK

Quantity affected

59 systems

Distribution

Worldwide - US Nationwide distribution.

Date initiated

2024-11-21

Date posted

2024-12-27

Location

Minneapolis, MN