SynchroMed EL System and SynchroMed II Implantable Infusion Pump

Starting date:

November 9, 2012

Posting date:

December 24, 2012

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-25923

• Reason
• Affected products

Recalled Products

1. SynchroMed EL System
2. SynchroMed II Implantable Infusion Pump

Reason

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.

Affected products