Reported Dec 11, 2019 · Terminated

Synchromed II programmable pump, Model numbers 8637-20 and 8637-40

Medtronic Neuromodulation

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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?

  • Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
Lot codes and dates
  • Product Number 8637-20 Serial Numbers

    2,713 of 2,713 codes

    • NGP000003H
    • NGP000008H
    • NGP000009H
    • NGP000011H
    • NGP000013H
    • NGP000014H
    • NGP000017H
    • NGP000018H
    • NGP000019H
    • NGP000020H
    • NGP000023H
    • NGP000024H
    • NGP000026H
    • NGP000027H
    • NGP000029H
    • NGP000031H
    • NGP000032H
    • NGP000033H
    • NGP000034H
    • NGP000035H
    • NGP000036H
    • NGP000037H
    • NGP000038H
    • NGP000039H
    • NGP000040H
    • NGP000046H
    • NGP000048H
    • NGP000071H
    • NGP000076H
    • NGP000086H
    • NGP000106H
    • NGP000107H
    • NGP000111H
    • NGP000119H
    • NGP000128H
    • NGP000138H
    • NGP000142H
    • NGP000143H
    • NGP000145H
    • NGP000150H
    • NGP000159H
    • NGP000160H
    • NGP000163H
    • NGP000176H
    • NGP000178H
    • NGP000184H
    • NGP000197H
    • NGP000198H
    • NGP000199H
    • NGP000204H
    • NGP000242H
    • NGP000245H
    • NGP000249H
    • NGP000251H
    • NGP000252H
    • NGP000253H
    • NGP000254H
    • NGP000255H
    • NGP000256H
    • NGP000257H
    NGP
Amount recalled
10820 units

Why it was recalled

Stop using this product now

There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 15, 2023 · Data as of Sep 19, 5:22 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.