Product Wiki · Recalls · Health Canada — Medical Devices

SynchroMed EL System and SynchroMed II Implantable Infusion Pump — recall 49209

Health Canada — Medical Devices · Canada · 2012-12-24 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
49209
Date of alert
2012-12-24
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Medtronic is mailing a safety notification to physicians associated with the synchromed infusion pump. This notification provides important information on medtronic neuromodulation's continuing efforts to investigate and communicate the impact of unapproved drugs on the performance of the synchromed infusion pump system. It includes information on motor gear corrosion, which has been identified as the primary contributor to pump motor stall in the synchromed ii and synchromed el pumps. This communication is intended to reinforce with healthcare professionals the importance of following the labeling with respect to the use of indicated drugs. All active implanting or managing physicians associated with the synchromed drug infusion pump are in scope for this communication.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/synchromed-el-system-and-synch

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