The Recall Desk
HighFDA (Devices)·Z-0772-2025·Announced 2025-01-08

SynchroMed II and III implantable pumps recalled for software issues

Medtronic recalled SynchroMed II and III implantable pumps for software issues in the clinician tablet application. Fifty-nine systems are affected.

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 a Class II recall for software issues in an implantable drug-delivery system with no reported illnesses or injuries. Per the FDA rubric, it qualifies as a risk-of-harm product where no injury has yet been reported, meeting the criteria for a High severity score.

Plain-English summary

Medtronic Neuromodulation has recalled SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps that are used with the PROG CT900C clinician tablet running A810 CP application version 2.x.

Software issues were identified in version 2.x of the A810 CP application. The recall involves 59 systems distributed nationwide and worldwide.

The recalled product

Product
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
Manufacturer
Medtronic Neuromodulation
Category
Medical Device — Implantable pump
Hazard
  • software-issue

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 (1)

  • GTIN: 00643169890961

Distribution

Distributed nationwide across the United States.

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