Medtronic Neuromodulation: Medical Device Recall in 2012 - (Recall #: Z-0497-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

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, and catheter accessories.

Product Classification:

Class I

Date Initiated: November 9, 2012

Date Posted: December 19, 2012

Recall Number: Z-0497-2013

Event ID: 63712

Reason for Recall:

Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion. UPDATE 2/1/2016: Medtronic received approval to incorporate enhancements to the SynchroMed II pump which decreases the potential for internal electrical shorting and motor corrosion, and is retrieving any unused pumps.

Status: Terminated

Product Quantity: 174,700 devices total

Code Information:

All SynchroMed EL and SynchroMed II pumps

Distribution Pattern:

Worldwide distribution: USA (nationwide) and countries including: Canada and Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated