[Recalled] Medtronic SynchroMed II, Model 8637-40, Programmable pump — Medtronic recently identified that if the SynchroMed II pump switches into tele… | FDA 2023-11-13

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.