Medtronic recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps with specific software versions due to potential software issues. Affected units include certain serial numbers and GTINs.
Software issues were identified in application version 2.x.
Medtronic is recalling SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps that use the PROG CT900D CLINICIAN TABLET GLOBAL with software version 2.x. This recall is due to identified software issues that could affect device performance.
The software issues identified in application version 2.x could potentially cause device malfunctions. However, the recall does not specify that these issues cause serious injury or death in normal use.
Patients using these specific implantable pumps with the PROG CT900D CLINICIAN TABLET GLOBAL and software version 2.x are affected. Medical professionals who use these pumps for patient treatment are most at risk.
Check if your pump has the SynchroMed II Model 8637 or SynchroMed III Model 8667 with the PROG CT900D CLINICIAN TABLET GLOBAL and software version 2.x. Look for the listed serial numbers or GTINs in the recall notice.
Verify your pump's software version by checking the device settings or consulting with your healthcare provider.
No, the recall does not require immediate discontinuation. Check your software version and contact Medtronic for guidance.
Contact Medtronic directly to update your software to a newer version that resolves the identified issues.
Check the serial numbers or GTINs listed in the recall notice. Affected units include specific serial numbers and GTINs provided in the record.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0773-2025 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0773-2025 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.