Z-1150-2008

Medtronic SynchroMed II Programmable Pump, model 8637-20. The contents of the inner package have been...

Name: Z-1150-2008 Medtronic SynchroMed II Programmable Pump, model 8637-20. The contents of the inner package have been...
Creator: Medtronic Neuromodulation
Published: 2008-01-16
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2008-01-16 / Terminated / root cause: design

FDA source

Medtronic Neuromodulation began a recall of Medtronic SynchroMed II Programmable Pump, model 8637-20. The contents of the inner package have been sterilized by ethylene oxide gas. 20 mL reservoir... on 2008-01-16. The reason FDA records is "Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1150-2008
Status: Terminated
Initiated: 2008-01-16
Posted: 2008-03-22
Terminated: 2011-06-06
Recalling firm: Medtronic Neuromodulation
Product: Medtronic SynchroMed II Programmable Pump, model 8637-20. The contents of the inner package have been sterilized by ethylene oxide gas. 20 mL reservoir. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. 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.
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 16, 2008, Medtronic sent a letter to doctors who implant these d
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent Medial Device Correction letter was sent January 16, 2008, to Health Care Professionals. The letter describes the incidences, symptoms and recommendations for patient management. Excerpts from the approved Medtronic Professional Labeling are also included with the letter. The firm has requested unreported inflammatory mass in a patient with a Medtroinc device to the firm and to the FDA MedWatch Program by phone at 1-800-FDA-1088. Additional assistance may be obtained by contacting Medtronic Neuromodulation Technical Services at 1-800-707-0933.
Quantity in commerce: ~102,792 worldwide. 90,330 within US and 12,462 OUS
Distribution: Worldwide Distribution -- USA including states of Washington D.C., Puerto Rico, and countries of Aruba, Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Faroe Islands, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Mexico, Netherlands, Netherlands Antilles, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City State.
Product codes and lots: all serial numbers

Product code LKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)