Medtronic recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E clinician tablets that have software version 2.x. This recall addresses potential software issues that could affect device function.
Software issues were identified in application version 2.x.
Medtronic is recalling specific implantable neurostimulation pumps (SynchroMed II Model 8637 and SynchroMed III Model 8667) that work with PROG CT900E clinician tablets and have software version 2.x. The issue is software-related but does not involve immediate safety risks; users should update the software to the latest version to avoid potential problems.
The software version 2.x has been identified as having potential issues that could affect device functionality. However, the recall does not indicate immediate safety risks like injury or death. The issue is related to software stability rather than critical safety mechanisms.
Patients using these specific implantable neurostimulation pumps with the identified software version. Healthcare providers who have these pumps in their systems may also be affected.
Check if your device is a SynchroMed II Model 8637 or SynchroMed III Model 8667 pump used with PROG CT900E clinician tablets and has software version 2.x. Serial numbers and GTINs are listed in the recall notice.
Download the latest software update from Medtronic's website to fix the identified software issues.
No, the recall does not require immediate discontinuation of use. The issue is software-related and can be resolved with an update.
Check if your pump is a SynchroMed II Model 8637 or SynchroMed III Model 8667 used with PROG CT900E clinician tablets and has software version 2.x. Serial numbers and GTINs are listed in the recall notice.
The recall states the software issues do not pose immediate safety risks like injury or death. The issue is related to device functionality rather than critical safety mechanisms.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0774-2025 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0774-2025 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.