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U.S. Department of Health and Human Services

Class 1 Device Recall Medtronic IsoMed

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  Class 1 Device Recall Medtronic IsoMed see related information
Date Initiated by Firm January 16, 2008
Date Posted March 22, 2008
Recall Status1 Terminated 3 on June 06, 2011
Recall Number Z-1154-2008
Recall Event ID 46685
PMA Number P860004 P990034 
Product Classification Implanted programmable infusion pump - Product Code LKK
Product Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-60. The contents of the inner package have been sterilized by ethylene oxide gas. Reservoir size: 60 mL. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic IsoMed Constant-Flow Infusion Pump is part of the IsoMed Constant-Flow Infusion System designed to contain and administer parenteral drugs to a specific site. The components of the IsoMed Constant-Flow Infusion System include the pump, Medtronic catheter, catheter accessories, Medtronic Refill kit, and Medtronic catheter access port kit. IsoMed pumps are implantable devices that store and dispense drugs according to a constant flow rate set during the manufacturing process.
Code Information all serial numbers
Recalling Firm/
Medtronic Neuromodulation
800 53rd Ave NE
PO Box 1250
Minneapolis MN 55440-1250
For Additional Information Contact Technical Services
Manufacturer 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
FDA Determined
Cause 2
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, 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LKK and Original Applicant = MEDTRONIC Inc.