Medtronic Neuromodulation: Medical Device Recall in 2012 - (Recall #: Z-0496-2013)

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:

SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter. The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual.

Product Classification:

Class I

Date Initiated: November 9, 2012

Date Posted: December 19, 2012

Recall Number: Z-0496-2013

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