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U.S. Department of Health and Human Services

Class 1 Device Recall Medtronic SynchroMed II

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  Class 1 Device Recall Medtronic SynchroMed II see related information
Date Initiated by Firm July 05, 2011
Date Posting Updated August 29, 2011
Recall Status1 Terminated 3 on August 24, 2012
Recall Number Z-3043-2011
Recall Event ID 59317
PMA Number P860004S056 
Product Classification implantable infusion pump - 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, and catheter accessories.
Code Information serial numbers: NGP000370R thru NGP002152R, NGP000565N thru NGP034132N, NGP005103H thru NGP350081H, NGP350083H, NGP350086H thru NGP350092H

NGP350094H thru NGP350414H, NGP350416H, NGP350417H, NGP350418H, NGP350419H, NGP350421H, NGP350422H, NGP350423H, NGP350424H, NGP350425H, NGP350427H, NGP350428H, NGP350429H, NGP350431H thru NGP350464H, NGP350466H, NGP350468H thru NGP350506H, NGP350509H thru NGP350576H, NGP350578H, NGP350579H, NGP350580H, NGP350581H, NGP350582H, NGP350583H, NGP350585H thru NGP350599H, NGP350601H, NGP350602H, NGP350603H, NGP350604H, NGP350606H thru NGP350814H, NGP350816H thru NGP350837H, NGP350839H thru NGP350852H, NGP350860H thru NGP350880H, NGP350882H thru NGP350905H, NGP350907H thru NGP350916H, NGP350918H thru NGP351197H, NGP351199H thru NGP351229H, NGP351231H thru NGP351258H, NGP351260H thru NGP351302H, NGP351304H thru NGP351337H, NGP351339H thru NGP351396H, NGP351398H thru NGP351456H, NGP351458H, NGP351459H, NGP351460H, NGP351461H, NGP351463H, NGP351464H, NGP351465H, NGP351467H thru NGP351497H, NGP351499H thru NGP351601H, NGP351603H thru NGP351617H, NGP351619H thru NGP351651H, NGP351653H, NGP351654H, NGP351656H thru NGP351800H, NGP351802H thru NGP351809H, NGP351811H thru NGP351824H, NGP351826H thru NGP351863H, NGP351865H, NGP351866H, NGP351868H thru NGP351904H, NGP351906H thru NGP351919H, NGP351921H thru NGP351996H, NGP351998H, NGP351999H, NGP352000H, NGP352001H, NGP352002H, NGP352003H, NGP352004H, NGP352005H, NGP352007H, NGP352009H thru NGP352149H, NGP352151H thru NGP352221H, NGP352223H thru NGP352250H, NGP352252H thru NGP352279H, NGP352281H thru NGP352403H, NGP352405H thru NGP352417H, NGP352419H thru NGP352442H, NGP352444H thru NGP352473H, NGP352475H, NGP352476H, NGP352477H, NGP352478H, NGP352480H thru NGP352548H, NGP352550H thru NGP352558H, NGP352560H, NGP352561H, NGP352562H, NGP352564H thru NGP352756H, NGP352758H thru NGP352778H, NGP352780H thru NGP352896H, NGP352898H thru NGP352918H, NGP352920H thru NGP353016H, NGP353018H thru NGP353085H, NGP353087H thru NGP353252H, NGP353254H thru NGP353296H, NGP353298H, NGP353299H, NGP353300H, NGP353301H, NGP353302H, NGP353303H, NGP353304H, NGP353305H, NGP353306H, NGP353308H thru NGP353364H, NGP353366H, NGP353367H, NGP353368H, NGP353369H, NGP353371H thru NGP353477H, NGP353479H, NGP353480H, NGP353481H, NGP353482H, NGP353484H thru NGP353505H, NGP353507H thru NGP353531H, NGP353533H thru NGP353599H, NGP353601H thru NGP353637H, NGP353639H, NGP353640H, NGP353641H, NGP353642H, NGP353643H, NGP353644H, NGP353645H, NGP353646H, NGP353647H, NGP353648H, NGP353649H, NGP353651H thru NGP353664H, NGP353666H thru NGP353739H, NGP353741H thru NGP353750H, NGP353752H, NGP353753H, NGP353754H, NGP353755H, NGP353756H, NGP353757H, NGP353758H, NGP353759H, NGP353760H, NGP353761H, NGP353763H thru NGP353789H, NGP353791H thru NGP353821H, NGP353823H, NGP353824H, NGP353825H, NGP353826H, NGP353827H, NGP353828H, NGP353830H, NGP353832H thru NGP353923H, thru NGP353947H, NGP353949H, NGP353951H, NGP353952H, NGP353953H, NGP353954H, NGP353956H, NGP353957H, NGP353958H, NGP353959H, NGP353960H, NGP353961H, NGP353962H, NGP353964H, NGP353965H, NGP353966H, NGP353967H, NGP353968H, NGP353969H, NGP353970H, NGP353971H, NGP353972H, NGP353973H, NGP353974H, NGP353976H, NGP353977H, NGP353978H, NGP353979H, NGP353980H, NGP353981H, NGP353982H, NGP353984H, NGP353985H, NGP353986H, NGP353987H, NGP353988H, NGP353989H, NGP353990H, NGP353991H, NGP353992H, NGP353993H, NGP353994H, NGP353995H, NGP353996H, NGP353999H, NGP354000H, NGP354001H, NGP354003H, NGP354004H, NGP354005H, NGP354006H, NGP354008H, NGP354010H thru NGP354031H, NGP354034H, NGP354035H, NGP354036H, NGP354037H, NGP354039H, NGP354040H, NGP354041H, NGP354042H, NGP354043H, NGP354044H, NGP354045H, NGP354046H, NGP354047H, NGP354048H, NGP354050H thru NGP354084H, NGP354086H thru NGP354174H, NGP354176H thru NGP354227H, NGP354229H thru NGP354236H, NGP354238H thru NGP354330H, NGP354332H thru NGP354343H, NGP354345H, NGP354346H, NGP354347H, NGP354348H, NGP354349H, NGP354351H
Recalling Firm/
Medtronic, Inc. - Neuromodulation
7000 Central Ave NE
Minneapolis MN 55432-3568
For Additional Information Contact Medtronic Patient Services
Manufacturer Reason
for Recall
Medtronic is updating information regarding the potential for reduced battery performance that can lead to sudden loss of therapy in a small percentage of Medtronic Model 8647 SynchroMed II pumps that was communicated with Healthcare providers in July 2009. The purpose of the current communication is to provide updated information regarding the scope and occurrence of this issue and to emphasize
FDA Determined
Cause 2
Component design/selection
Action Medtronic Neuromodulation notified physicians with an Urgent Medical Device Correction letter beginning July 05, 2011. A press was issued July 08, 2011. The letter described the issue, severity, recommendations if they notice issue, and patient management recommendations. UPDATE: in November 2011, MDT began to exchange unused pumps in inventory with pumps that contained the new battery. A letter dated November 2011 was left behind at locations in which the MDT representative swapped out the devices.
Quantity in Commerce 139,653 (105,002 US, 34,61 OUS)
Distribution Worldwide including USA, Puerto Rico, Algeria, Aruba, Australia, Austria, Belarus, Belgium, Brazil, Chile. Colombia. Costa Rica. Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, India, Iran Iraq, Ireland, Israel Italy, Jordan, Kuwait, Lebanon, Lithuania, Luxembourg, Malta, Martinique, Mexico, Morocco, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Norway, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Uruguay.
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.