The Recall Desk
HighFDA (Devices)·Z-1771-2021·Announced 2021-06-09

MiniMed 780G Insulin Pump Software Fault Risks Overdose

A software design flaw in the MiniMed 780G Insulin Pump can cause insulin over-delivery. If users deliver an additional bolus without knowing their active insulin level, they risk receiving too much insulin.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a medical device with a known software defect creating a risk of insulin over-delivery. FDA Class II recall with no reported illnesses or injuries, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

The MiniMed 780G Insulin Pump is being recalled due to a software design issue. Approximately 15,682 pumps were distributed in the U.S. for clinical use, with additional units distributed internationally. A software fault can occur when a large bolus (insulin dose) is delivered at quick bolus speed.

If the user is not aware of their current active insulin level and delivers an additional bolus after this fault occurs, there is a risk of insulin over-delivery.

The recalled product

Product
MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL;¿ KIT MMT-1896WW MM780G 6.5W BLE SF MG;¿ PUMP MMT-1884XC 780G V6.5 CLIN US MG;¿ PUMP MMT-1885XC 780G V6.5 CLIN MM;¿ PUMP MMT-18
Manufacturer
Medtronic Minimed
Category
Medical Device — Insulin Pump
Hazard
  • insulin-overdose
  • software-fault

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model#(CFN)/UDI-DI(GTIN): MMT-1885/00763000384258
  • ¿ MMT-1886/00763000384265
  • ¿ MMT-1895WW/00763000384272
  • ¿ MMT-1896WW/00763000384289
  • ¿ MMT-1884XC/ 00763000455613
  • ¿ MMT-1885XC/00763000421939
  • ¿ MMT-1886XC/00763000421946
  • ¿ MMT-1885L/00763000441432
  • ¿ MMT-1886L/00763000441449
  • ¿ MMT-1896ES/00763000454296
  • ¿ MMT-1896WWA/00763000411541
  • ¿ KIT MMT-1895WWA/00763000411374
  • ¿ KIT MMT-1895WWA/00763000411381
  • ¿ KIT MMT-1895WWA/00763000411398
  • ¿ KIT MMT-1895WWA/00763000411404
  • ¿ KIT MMT-1895WWA/00763000411411
  • ¿ KIT MMT-1895WWA/00763000411428
  • ¿ KIT MMT-1895WWA/00763000411435
  • ¿ KIT MMT-1895WWA/00763000411459
  • ¿ KIT MMT-1895WWA/00763000411466

Distribution

Distributed in 12 states:

  • AR
  • CA
  • CO
  • CT
  • FL
  • GA
  • ID
  • MI
  • MN
  • TN
  • TX
  • WA

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