Reported Jun 3, 2015 · Terminated

Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable…

Medtronic Neuromodulation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568

Is this the product you have?

  • Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile
  • Product UsageThe implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter
Lot codes and dates
  • US Serial Number

    1,576 of 1,576 codes

    • NGP411628H
    • NGP411629H
    • NGP411685H
    • NGP411704H
    • NGP411801H
    • NGV501193H
    • NGP410146H
    • NGP410147H
    • NGP410148H
    • NGP410149H
    • NGP410151H
    • NGP410153H
    • NGP410156H
    • NGP410160H
    • NGP410162H
    • NGP410163H
    • NGP410169H
    • NGP410171H
    • NGP410175H
    • NGP410177H
    • NGP410178H
    • NGP410179H
    • NGP410181H
    • NGP410182H
    • NGP410183H
    • NGP410184H
    • NGP410186H
    • NGP410188H
    • NGP410189H
    • NGP410190H
    • NGP410191H
    • NGP410196H
    • NGP410197H
    • NGP410198H
    • NGP410200H
    • NGP410201H
    • NGP410204H
    • NGP410206H
    • NGP410213H
    • NGP410215H
    • NGP410216H
    • NGP410217H
    • NGP410219H
    • NGP410220H
    • NGP410221H
    • NGP410223H
    • NGP410230H
    • NGP410231H
    • NGP410233H
    • NGP410234H
    • NGP410237H
    • NGP410240H
    • NGP410241H
    • NGP410244H
    • NGP410950H
    • NGP410956H
    • NGP410964H
    • NGP410968H
    • NGP410969H
    • NGP410970H
    OUS Serial Number

    325 of 325 codes

    • NGP410145H
    • NGP410155H
    • NGP410157H
    • NGP410158H
    • NGP410159H
    • NGP410165H
    • NGP410166H
    • NGP410174H
    • NGP410187H
    • NGP410194H
    • NGP410203H
    • NGP410209H
    • NGP410212H
    • NGP410224H
    • NGP410225H
    • NGP410226H
    • NGP410227H
    • NGP410228H
    • NGP410229H
    • NGP410232H
    • NGP410243H
    • NGP411106H
    • NGP411109H
    • NGP411112H
    • NGP411115H
    • NGP411116H
    • NGP411119H
    • NGP411121H
    • NGP411122H
    • NGP411124H
    • NGP411125H
    • NGP411126H
    • NGP411130H
    • NGP411137H
    • NGP411140H
    • NGP411141H
    • NGP411145H
    • NGP411148H
    • NGP411150H
    • NGP411151H
    • NGP411152H
    • NGP411153H
    • NGP411156H
    • NGP411160H
    • NGP411166H
    • NGP411167H
    • NGP411168H
    • NGP411170H
    • NGP411172H
    • NGP411173H
    • NGP411174H
    • NGP411175H
    • NGP411177H
    • NGP411180H
    • NGP411181H
    • NGP411182H
    • NGP411184H
    • NGP411185H
    • NGP411188H
    • NGP411190H
Amount recalled
1901 (1576 US, 325 OUS)

Where it was sold

Why it was recalled

Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm could cease to function.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 23, 2015 · Data as of Sep 19, 5:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.