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U.S. Department of Health and Human Services

Class 1 Device Recall SynchroMed II Implantable Infusion Pump

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  Class 1 Device Recall SynchroMed II Implantable Infusion Pump see related information
Date Initiated by Firm June 03, 2013
Date Posted June 25, 2013
Recall Status1 Terminated 3 on November 16, 2015
Recall Number Z-1579-2013
Recall Event ID 65443
PMA Number P860004S056 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
Product Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II infusion system include the pump, catheter,r and catheter accessories

The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of drugs or fluids:
Code Information all SynchroMed II pumps
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave NE
Minneapolis MN 55432-3568
For Additional Information Contact Technical Services
800-707-0933
Manufacturer Reason
for Recall		 Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therapy which may result in the return of und
FDA Determined
Cause 2		 Device Design
Action Medtronic sent an Urgent Medical Device Correction letter dated May 2013, to all affected customers. The letter described the issue of the pump's potentially shorting, how to identify if a pump is affected, and provided ongoing patient management recommendations. The Medtronic Rep would complete a Physician Notification Confirmation Form. A copy of the recall notification letter and the completed Confirmation Form is to be left with the physician. Customers with questions were instructed to call 1-800-707-0933. For questions regarding this recall call 763-526-9738.
Quantity in Commerce 261,109 total devices estimated implanted Worldwide
Distribution worldwide
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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