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U.S. Department of Health and Human Services

Class 1 Device Recall Medtronic SynchroMed EL

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  Class 1 Device Recall Medtronic SynchroMed EL see related information
Date Initiated by Firm June 06, 2006
Date Posted October 20, 2006
Recall Status1 Terminated 3 on July 06, 2010
Recall Number Z-0022-2007
Recall Event ID 35595
PMA Number P860004S042 
Product Classification Programmable implanted infusion pump - Product Code LKK
Product Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.
Code Information Model 8627-10, serial numbers: NGE000001 - NGE000242R .  Model 8627-18, serial numbers: NGF000001 - NGF003266R.  Model 8627L-10, serial numbers: NGG000001R - NGG000068R,  Model 8627L-18, serial numbers: NGH000001R - NGH001780R.
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
800 53rd Ave NE
PO Box 1250
Minneapolis MN 55440-1250
Manufacturer Reason
for Recall		 The Catheter Access Port (CAP) on SynchroMed EL pumps manufactured between March and July 1999 may detach from the main body of the pump, which can interrupt drug flow to the target site.
FDA Determined
Cause 2		 Process design
Action An Urgent medical Device Recall letter was sent to healthcare providers beginning June 06, 2006. The letter describes the issue, patient risk, identifies affected devices, and provides patient Management recommendations. The letter also asks for a response card to be returned to Medtronic. Patients may contact Medtronic Neurological Patient Services at 1-800-510-6735.
Quantity in Commerce 4,317 pumps
Distribution Worldwide distribution ---- including USA, Argentina, Barbados, Canada, Germany, India, Ireland, Italy, Mexico, The Netherlands, Spain, Switzerland, and United Kingdom.
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.
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