Voluntary recall of specific serial numbers of SynchroMed™ II Implantable Infusion Pumps Models 8637-20, 8637-40 due to potential motor stall

Medtronic International Limited would like to inform healthcare professionals of a voluntary recall of specific serial numbers of SynchroMed^™ II Implantable Infusion Pumps Models 8637-20 and 8637-40. The recall is 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. A permanent pump motor stall will result in cessation of drug infusion therapy and possibly return of underlying symptoms and/or withdrawal symptoms. There has been no statistical change in the overall rate of pump motor stalls (all causes). Healthcare professionals are advised against prophylactic replacement of potentially affected SynchroMed^™ II pumps due to the low observed occurrence of motor stall from this issue, the presence of pump alarms, and the risks associated with replacement surgery. Please refer to the letter for details. Published: 19 Nov 2019

Dear Healthcare Professional Letters