Reported Jan 2, 2019 · Ongoing

Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G…

Medtronic Inc.

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 Inc. · 18000 Devonshire St · Northridge, CA · 91325-1219

Is this the product you have?

  • Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
Lot codes and dates
  • Serial Numbers

    2,716 of 2,716 codes

    • NG1330099H
    • NG1330154H
    • NG1329859H
    • NG1330107H
    • NG1330110H
    • NG1330113H
    • NG1330122H
    • NG1330133H
    • NG1330136H
    • NG1330140H
    • NG1330142H
    • NG1330143H
    • NG1330145H
    • NG1330160H
    • NG1330143H
    • NG1330142H
    • NG1330140H
    • NG1330136H
    • NG1330133H
    • NG1330122H
    • NG1330113H
    • NG1330110H
    • NG1330107H
    • NG1329859H
    • NG1330145H
    • NG1330160H
    • NG1330160H
    • NG1330145H
    • NG1330143H
    • NG1330142H
    • NG1330140H
    • NG1330136H
    • NG1330133H
    • NG1330122H
    • NG1330113H
    • NG1330110H
    • NG1330107H
    • NG1329859H
    • NG1399727H
    • NG1399183H
    • NG1399310H
    • NG1400412H
    • NG1399761H
    • NG1399740H
    • NG1399750H
    • NG1400409H
    • NG1400138H
    • NG1400067H
    • NG1400445H
    • NG1400080H
    • NG1400332H
    • NG1400078H
    • NG1400458H
    • NG1400416H
    • NG1400350H
    • NG1400420H
    • NG1400003H
    • NG1399926H
    • NG1400448H
    • NG1400674H
Amount recalled
142889

Where it was sold

Why it was recalled

Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:51 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.