Product Wiki · Recalls · Health Canada — Medical Devices

SynchroMed II - Programmable Pump (2019-10-11) — recall 60045

Health Canada — Medical Devices · Canada · 2019-10-22 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
60045
Date of alert
2019-10-22
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Medtronic is voluntarily retrieving specific Synchromed II Implantable Drug Infusion Pumps after investigating complaints related to permanent motor stall. This voluntary recall is being conducted due to the potential for the presence of a foreign particle inside the pump motor assembly which could interfere with motor gear rotation and lead to a permanent motor stall. The source of the foreign particle has been identified and eliminated. A permanent pump motor stall will result in cessation of drug infusion therapy which may result in return of underlying symptoms and/or withdrawal symptoms.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/synchromed-ii-programmable-pum

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