The Recall Desk
HighFDA (Devices)·Z-0855-2022·Announced 2022-04-06

Medtronic MiniMed insulin pumps may not deliver basal insulin without configuration

Medtronic MiniMed insulin pumps may be used without programmed basal rates, causing insulin under-delivery and potentially severe high blood sugar. Patients must configure and save basal settings before use, but labeling doesn't clearly explain this requirement.

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 an FDA Class II recall involving a serious potential hazard—insulin under-delivery can cause severe hyperglycemia and diabetic ketoacidosis. However, the source text documents no reported illnesses or injuries, making the risk theoretical rather than realized. Per the rubric, theoretical risks of serious harm without reported incidents score as High (3).

Plain-English summary

Medtronic is recalling certain MiniMed insulin pump models (630G, 670G, 770G, and international variants 620G, 640G, 720G, 780G) distributed across all US states and in Australia, Japan, Korea, New Zealand, Taiwan, and Vietnam. Approximately 175,801 units are affected.

New or replacement pumps are not pre-programmed with basal insulin rates. Patients who receive a pump without realizing it must be configured before use may inadvertently operate it with the default 0.0 units/hour basal rate, receiving no insulin throughout the day. This can cause severe high blood sugar (hyperglycemia) and may lead to diabetic ketoacidosis, a serious condition requiring emergency care.

The device labeling does not clearly state that pumps can operate with a default 0.0 units/hour basal setting with no alarm or error message. The labeling also fails to adequately explain that configuring and saving basal rates requires multiple specific steps, and that incomplete execution of these steps will not save the new settings. Instructions for setting basal profiles and related parameters used by the bolus calculator are similarly unclear.

If you use one of these MiniMed pumps, confirm with your healthcare provider or pump manufacturer that your basal rates and other settings are properly programmed and saved before using the device. Review your pump settings immediately and do not use the pump if you are unsure whether your basal rates have been correctly configured.

The recalled product

Product
MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed 770G: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 620G (OUS Only): MMT-1750; MiniMed 640G (OUS O
Manufacturer
Medtronic MiniMed
Category
Medical Device — Insulin Pump
Hazard
  • insulin-under-delivery
  • hyperglycemia
  • diabetic-ketoacidosis
  • labeling-error

Distribution

Distributed in 53 states:

  • AK
  • AL
  • AR
  • AZ
  • CA
  • CO
  • CT
  • DC
  • DE
  • FL
  • GA
  • HI
  • IA
  • ID
  • IL
  • IN
  • KS
  • KY
  • LA
  • MA
  • MD
  • ME
  • MI
  • MN
  • MO
  • MS
  • MT
  • NC
  • ND
  • NE
  • NH
  • NJ
  • NM
  • NV
  • NY
  • OH
  • OK
  • OR
  • PA
  • PR
  • RI
  • SC
  • SD
  • TN
  • TX
  • UT
  • VA
  • VI
  • VT
  • WA
  • WI
  • WV
  • WY

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