Medtronic Neuromodulation Medtronic SynchroMed II Programmable Pump, Model 8637-20. 20 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed II programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories. Medtronic, Inc., 710 Medtronic Parkway, Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic SynchroMed II Programmable Pump, Model 8637-20. 20 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed II programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories. Medtronic, Inc., 710 Medtronic Parkway,
Brand
Medtronic Neuromodulation
Lot Codes / Batch Numbers
All SynchroMed EL and SynchroMed II pumps.
Products Sold
All SynchroMed EL and SynchroMed II pumps.
Medtronic Neuromodulation is recalling Medtronic SynchroMed II Programmable Pump, Model 8637-20. 20 mL Reservoir. The contents [STERILE] due to Medtronic issued a letter to healthcare professionals providing important safety information regarding MRI (magnetic resonance imaging) effects on Syn. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
WA, PR
Page updated: Jan 10, 2026