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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-2181-2008
Recall Event ID 48635
PMA Number P860004S056 
Product Classification Pump, programmable - Product Code LKK
Product Medtronic Synchromed II Programmable Pump , Medtronic Inc., Minneapolis, MN 55432-5604
20 ml Pumps Model 8637-20
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 NGP300011H- NGP307363H  NGP307409H NGP307456H NGP307464H NGP307466H NGP307467H NGP307473H NGP307481H NGP307482H NGP307485H NGP307486H NGP307487H NGP307488H NGP307489H NGP307490H NGP307491H NGP307493H NGP307494H NGP307495H NGP307496H NGP307499H NGP307500H NGP307501H NGP307502H NGP307503H NGP307504H NGP307505H NGP307506H NGP307507H NGP307508H NGP307509H NGP307510H NGP307511H NGP307518H NGP307519H NGP307520H NGP307522H NGP307523H NGP307525H NGP307532H NGP307539H NGP307542H NGP307547H NGP307550H NGP307553H NGP307554H NGP307556H NGP307558H NGP307559H NGP307562H NGP307564H NGP307566H NGP307567H NGP307568H NGP307570H NGP307572H NGP307574H NGP307575H NGP307577H NGP307579H NGP307581H NGP307582H NGP307583H NGP307584H NGP307587H NGP307591H NGP307593H NGP307594H NGP307595H NGP307596H NGP307597H NGP307598H NGP307600H NGP307602H NGP307603H NGP307604H NGP307606H NGP307608H NGP307609H NGP307612H NGP307614H NGP307616H NGP307618H NGP307619H NGP307620H NGP307621H NGP307623H NGP307624H NGP307625H NGP307626H NGP307627H NGP307628H NGP307629H NGP307633H NGP307634H NGP307636H NGP307640H NGP307642H NGP307643H NGP307644H NGP307645H NGP307646H NGP307647H NGP307648H NGP307649H NGP307652H NGP307654H NGP307655H NGP307657H NGP307658H NGP307659H NGP307660H NGP307662H NGP307663H NGP307853H NGP309113H, and NGP309162H. 
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 7468
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.
PMA Database PMAs with Product Code = LKK and Original Applicant = MEDTRONIC Inc.
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