Health product recall

Synchromed II - Programmable Pump

Brand(s)
Last updated

Summary

Product
Synchromed II - Programmable Pump
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Synchromed II - Programmable Pump

More than 10 numbers, contact manufacturer.

8637-20
8637-40

Issue

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. In this case, drug delivery will only resume after performing a post MRI pump interrogation with the clinician programmer which will end telemetry mode.

Recall Start Date: November 21, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Medtronic Inc

710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74681

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