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, Minneapolis, MN 55432-5604, USA. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the follosing drugs or fluids: -chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of preservative-free morphine sulfate sterile solution. - chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of serve chronic pain. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of preservative-free ziconotide sterile solution after the initial fill of the pump with this drug. -chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of Lioresal Intrathecal (baclofen Injection). -Chronic intravascular infusion of floxuridine, (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Bacteriostatic water or preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of chemotherapy drugs or to flush the pump reservoir. Saline or heparinized saline (unless contraindicated) may be used during an interruption in chemotherapy to maintain pump and catheter patency.

Recall number

Z-0591-2009

Recalling firm

Medtronic Neuromodulation

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, Minneapolis, MN 55432-5604, USA. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the follosing drugs or fluids: -chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of preservative-free morphine sulfate sterile solution. - chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of serve chronic pain. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of preservative-free ziconotide sterile solution after the initial fill of the pump with this drug. -chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of Lioresal Intrathecal (baclofen Injection). -Chronic intravascular infusion of floxuridine, (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Bacteriostatic water or preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of chemotherapy drugs or to flush the pump reservoir. Saline or heparinized saline (unless contraindicated) may be used during an interruption in chemotherapy to maintain pump and catheter patency.

Status

Terminated

Initiated

2008-08-25

Posted

2009-01-26

Terminated

2012-05-17

Reason

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

Root cause

Labeling Change Control

Action

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.

Quantity

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, French Polynesia, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy , Jordan Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia and Montenegro, Slovakia, Slovenia, Sough Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City State, New Caledonia, Brazil, Dominican Republic, Mexico, Hong Kong, Singapore, Canada, Australia and Japan.

Lot, serial or model codes

All SynchroMed EL and SynchroMed II pumps.

510(k) numbers

not on file

PMA numbers

["P860004S056"]

Product code

LKK

Firm FEI

2182207

Firm city

Minneapolis

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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