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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic SynchroMed II Programmable Pump

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  Class 2 Device Recall Medtronic SynchroMed II Programmable Pump see related information
Date Initiated by Firm May 01, 2008
Date Posted September 03, 2008
Recall Status1 Terminated 3 on December 11, 2011
Recall Number Z-2182-2008
Recall Event ID 48635
Product Classification Pump, programmable - Product Code LKK
Product Medtronic Synchromed II Programmable Pump , Medtronic Inc., Minneapolis, MN 55432-5604
40 ml Pumps Model 8637-40
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.
Code Information NGV300002H - NGV405839H  NGV405840H NGV405842H NGV405843H NGV405844H NGV405848H NGV405849H NGV405850H NGV405853H NGV405854H NGV405856H NGV405858H NGV405859H NGV405860H NGV405861H NGV405862H NGV405870H NGV405871H NGV405873H NGV405874H NGV405875H NGV405877H NGV405879H NGV405880H NGV405883H NGV405884H NGV405888H NGV405890H NGV405896H NGV405897H NGV405898H NGV405899H NGV405900H NGV405901H NGV405902H NGV405903H NGV405904H NGV405905H NGV405906H NGV405907H NGV405908H NGV405909H NGV405911H NGV405913H NGV405915H NGV405916H NGV405917H NGV405919H NGV405920H NGV405922H NGV405928H NGV405929H NGV405930H NGV405931H NGV405932H NGV405934H NGV405935H NGV405936H NGV405937H NGV405939H NGV405942H NGV405943H NGV405944H NGV405946H NGV405947H NGV405949H NGV405951H NGV405952H NGV405957H NGV405959H NGV405961H NGV405963H NGV405964H NGV405965H NGV405967H NGV405968H NGV405969H NGV405970H NGV405971H NGV405972H NGV405973H NGV405974H NGV405975H NGV405976H NGV405978H NGV405979H NGV405980H NGV405981H NGV405982H NGV405983H NGV405985H NGV405990H NGV405992H NGV405994H NGV405995H NGV405996H NGV405997H NGV405999H NGV406001H NGV406002H NGV406006H NGV406008H NGV406010H NGV406011H NGV406012H NGV406013H NGV406014H NGV406015H NGV406016H NGV406017H NGV406018H NGV406021H NGV406022H NGV406023H NGV406024H NGV406025H NGV406028H NGV406029H NGV406030H NGV406031H NGV406032H NGV406033H NGV406034H NGV406037H NGV406038H NGV406039H NGV406040H NGV406041H NGV406044H NGV406046H NGV406047H NGV406048H NGV406049H NGV406050H NGV406051H NGV406052H NGV406053H NGV406054H NGV406055H NGV406056H NGV406058H NGV406059H NGV406060H NGV406061H NGV406062H NGV406063H NGV406064H NGV406066H NGV406067H NGV406068H NGV406069H NGV406071H NGV406072H NGV406073H NGV406075H NGV406076H NGV406078H NGV406080H NGV406082H NGV406083H NGV406084H NGV406085H NGV406086H NGV406087H NGV406089H NGV406090H NGV406091H NGV406092H NGV406094H NGV406095H NGV406096H NGV406097H NGV406099H NGV406100H NGV406101H NGV406104H NGV406105H NGV406106H NGV406107H NGV406108H NGV406109H NGV406110H NGV406112H NGV406113H NGV406114H NGV406117H NGV406118H NGV406119H NGV406122H NGV406123H NGV406125H NGV406126H NGV406127H NGV406128H NGV406129H NGV406131H NGV406132H NGV406133H NGV406134H NGV406135H NGV406137H NGV406164H NGV406169H NGV406174H NGV406187H NGV406227H NGV406627H NGV406747H NGV407899H NGV407906H, and NGV408059H. 
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
800 53rd Ave NE
PO Box 1250
Minneapolis MN 55440-1250
For Additional Information Contact
763-514-5174
Manufacturer Reason
for Recall		 SynchroMed II pumps (non-implanted) may have been manufactured without propellant.
FDA Determined
Cause 2		 Process control
Action Consignees were contacted by "Medtronic Urgent: Medical Device Recall" letters dated May 2008. The SynchoMed II pumps may have been manufactured without propellant. This device is limited to non-implanted SynchoMedl II pumps. Physcians should not impant these potentially affected pumps. The notifcation provides information on how to identify Pumps Without Propellant, Patient Management Recommendations and Additional Resources. A separate letter was issued to Inventory/Risk Mangers. The letter described the product and problem and included a section on the Product Recall, Returning Product and Accounting for Lost Inventory Product. Contact Medtronic at 1-800-707-0933.
Quantity in Commerce 6047
Distribution AK, AL, AR, AZ, CA, DO, CT, DC, DE, FL, GA, HI, IA, ID, IL IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, HY, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, DS, TN, TX, UT, VA, VT, WA, WI, WV, WY, Australia, Canada ,Austria, Belgium, Cyprus, Russian Federation, Czech Republic, Denmark, Finland, France, French Polynesia, Germany, Greece, Hungary, Iceland, India, Ireland, Italy, Kuwait, Luxembourg, Netherlands, Norway, Poland, Portugal, Reunion, San Marino, Slovenia, South Africa, Spain, Sweden Switzerland, Turkey, United Arab Emirates, United Kingdom, Vatican City, Saudi Arabia, Hong Kong, Latin America, Brazil, Puerto Rico, and Dominican Republic.
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.
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