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
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
SynchroMed II - Programmable Pump
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 8637-20
- 8637-40
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES