Medtronic SynchroMed EL Programmable Pump, Model 8627L-10. 10 mL Reservoir. The contents [STERILE] of the inner package

FDA device recall Z-0588-2009 · posted 2009-01-26 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Medtronic issued a letter to healthcare professionals providing important safety information regarding MRI (magnetic resonance imaging) effects on SynchroMed EL and SynchroMed II implantable infusion pumps. As stated in product labeling, the magnetic field of an MRI will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration of MRI exposure for all SynchroMed pump

Action taken

An Urgent Medical Device Correction, Important Information on Potential MRI Effects letter, dated August 2008, was sent to health care professionals beginning August 25, 2008. The letter described the issue, provided patient management recommendations and included enclosures: Roller Study Procedure to confirm pump function, Post MRI Pump Interrogation Guidelines and New Information Regarding Potential MRI Effects.

Root cause

Labeling Change Control

Status

Terminated

Product code

LKK

Quantity affected

Approx 76,253 of all devices.

Distribution

Worldwide Distribution --- USA including Washington D.C., and Puerto Rico, and countries of Algeria, Aruba, Austria, Belarus, Belgium, Croatia, Cyprus Czech Republic, Denmark, Egypt, Finland, France,

Date initiated

2008-08-25

Date posted

2009-01-26

Date terminated

2012-05-17

Location

Minneapolis, MN