Reported Oct 9, 2024 · Ongoing
MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF:…
Medtronic MiniMed, Inc.
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 MiniMed, Inc. · 18000 Devonshire St · Northridge, CA · 91325-1219
Is this the product you have?
- MiniMed 630G Insulin Pump
- REF
MMT-1515MMT-1714MMT-1715MMT-1754MMT-1755MiniMed 700G Insulin Pump
- REF
MMT-1800MMT-1801MMT-1805MMT-1850MMT-1851
- Lot codes and dates
7 of 7 products
Products covered by this recall # Barcodes Product as published 1 0064316978239600763000253059MMT-1714/00643169782396, 00763000253059 2 0064316987384100763000190446006431697527266431698738340076300031759100763000316655763000367053763000316655763000316655037630001904397630003166317630001665197630000725207630003166550176300025680776300009019764316965684076300031668600643169656840007630000901970076300019043900763000316631MMT-1715/00643169873841, 00763000190446, 00643169752726, 643169873834, 00763000317591, 00763000316655, 763000367053, 763000316655, 76300031665503, 763000190439, 763000316631, 763000166519, 763000072520, 76300031665501, 763000256807, 763000090197, 643169656840, 763000316686, 00643169656840, 00763000090197, 00763000190439, 00763000316631 3 6431697527266431698738417630001904467630001015277630003175910076300031759176300036709176300017963276300031762164316987864876300015704376300031759103006431697527267630003175910176300031762103763000317621010076300010152700763000190446MMT-1755/643169752726, 643169873841, 763000190446, 763000101527, 763000317591, 00763000317591, 763000367091, 763000179632, 763000317621, 643169878648, 763000157043, 76300031759103, 00643169752726, 76300031759101, 76300031762103, 76300031762101, 00763000101527, 00763000190446 4 00763000531157MMT-1801/00763000531157 5 00763000561680MMT-1805/00763000561680 6 00763000552541MMT-1850/00763000552541 7 0076300085473700763000541323MMT-1851/00763000854737, 00763000541323. All serial numbers. - Amount recalled
- 24,595
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Stop using this product now
Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.
Using this product could cause serious injury, illness or death — stop using it now.
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