SynchroMed II - Programmable Pump (2019-10-11)

Starting date:

October 11, 2019

Posting date:

October 22, 2019

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-71393

Last updated: 2019-10-22

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  Reason
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  Affected products

Affected Products

SynchroMed II - Programmable Pump

Reason

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.

Affected products