Medtronic Neuromodulation: Medical Device Recall in 2013 - (Recall #: Z-1579-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II infusion system include the pump, catheter,r and catheter accessories The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of drugs or fluids:

Product Classification:

Class I

Date Initiated: June 3, 2013

Date Posted: July 3, 2013

Recall Number: Z-1579-2013

Event ID: 65443

Reason for Recall:

Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therapy which may result in the return of und

Status: Terminated

Product Quantity: 261,109 total devices estimated implanted Worldwide

Code Information:

all SynchroMed II pumps

Distribution Pattern:

worldwide

Voluntary or Mandated:

Voluntary: Firm initiated