Medtronic recalls SynchroMed II programmable pumps (model 8637-20) due to potential failure to resume drug delivery after MRI scans when electromagnetic interference occurs. Affected units have specific serial numbers listed in the recall.
Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.
Medtronic is recalling certain SynchroMed II programmable pumps (model 8637-20) because they may not resume drug delivery after leaving an MRI machine if electromagnetic interference causes the pump to switch into telemetry mode while sounding an alarm. This could lead to treatment interruption during MRI procedures.
If the pump switches into telemetry mode due to electromagnetic interference from an MRI scan while it's sounding an alarm, it may not resume drug delivery once the patient leaves the MRI magnetic field. This could interrupt treatment during MRI procedures.
Patients using Medtronic SynchroMed II pumps (model 8637-20) who have the specific serial numbers listed in the recall are most at risk. These patients may need to avoid MRI scans without proper precautions.
Check if your pump has the model number 8637-20 and one of the listed serial numbers (e.g., NGP756746H, NGP000266H, etc.). The recall includes specific serial numbers provided in the official notice.
Verify your pump model is 8637-20 and has one of the listed serial numbers.
Reach out to Medtronic customer support for guidance on next steps.
No, but you should check if your pump is affected by this recall. The recall does not require immediate discontinuation of use.
Patients with affected pumps should consult Medtronic before undergoing MRI scans to ensure proper precautions are taken.
Check your pump's serial number against the list of affected units provided in the recall notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0614-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0614-2024 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.
