Medtronic Neuromodulation: Medical Device Recall in 2014 - (Recall #: Z-1570-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter.

Product Classification:

Class II

Date Initiated: February 26, 2014

Date Posted: May 14, 2014

Recall Number: Z-1570-2014

Event ID: 67720

Reason for Recall:

This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, Medtronic is not re

Status: Terminated

Product Quantity: 195,198 pumps (146,435 US, 48,763 OUS)

Code Information:

This Medical Device Correction notification affects all SynchroMed II pumps.

Distribution Pattern:

Worldwide Distribution - All states in USA. OUS: List not provided at this time.

Voluntary or Mandated:

Voluntary: Firm initiated