Medtronic recalls SynchroMed II programmable pumps (model 8637-40) that may stop drug delivery after MRI scans due to electromagnetic interference. Affected units have specific serial numbers and GTINs.
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 8637-40) because they can stop drug delivery after leaving an MRI machine due to electromagnetic interference. This risk occurs when the pump switches to telemetry mode during an MRI scan while sounding an alarm.
If the pump switches to telemetry mode due to electromagnetic interference from an MRI scan while sounding an alarm, it may not resume drug delivery once the patient leaves the MRI magnetic field. This inconsistency with labeling creates a potential risk during MRI procedures.
Patients using Medtronic SynchroMed II programmable pumps with model number 8637-40 are most at risk. The recall affects specific units identified by serial numbers and GTINs.
Check if your pump has model number 8637-40. Affected units include specific serial numbers and GTINs listed in the recall notice.
Identify your pump model number (8637-40) and compare with the list of affected serial numbers and GTINs provided in the recall.
No action is needed if you do not use MRI scans. The risk only occurs during MRI procedures.
Check your pump's model number (8637-40) and compare with the list of affected serial numbers and GTINs provided in the recall notice.
The recall does not specify a fix or remedy. Affected units should be checked against the list of serial numbers and GTINs.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0615-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0615-2024 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.
