MiniMed Mio AdvanceRecalls & reported problems across all models

We found 12 models of MiniMed Mio Advance by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 11,094 adverse event reports in the FDA's MAUDE database, received between Jun 2, 2020 and Sep 30, 2026 — classified as 24 deaths, 2,722 injuries, 8,348 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4,689 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported MiniMed Mio Advance problems

MiniMed Mio Advance models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MiniMed™ Mio™ Advance MMT-242A

  Set, Administration, Intravascular
  15 deaths8,164 reports
• MiniMed™ Mio™ Advance MMT-243A

  Set, Administration, Intravascular
  3 deaths1,563 reports
• MiniMed™ Mio™ Advance MMT-213A

  Set, Administration, Intravascular
  4 deaths532 reports
• MiniMed™ Mio™ Advance MMT-244A

  Set, Administration, Intravascular
  1 death391 reports
• MiniMed™ Mio™ Advance MMT-242AT

  Set, Administration, Intravascular
  298 reports
• MiniMed™ Mio™ Advance MMT-243AT

  Set, Administration, Intravascular
  81 reports
• MiniMed™ Mio™ Advance MMT-242

  Set, Administration, Intravascular
  1 death50 reports
• MiniMed™ Mio™ Advance MMT-242T

  Set, Administration, Intravascular
  6 reports
• MiniMed™ Mio™ Advance MMT-213

  Set, Administration, Intravascular
  5 reports
• MiniMed™ Mio™ Advance MMT-243

  Set, Administration, Intravascular
  2 reports
• MiniMed™ Mio™ Advance MMT-231

  Set, Administration, Intravascular
  1 report
• MiniMed™ Mio™ Advance MMT-242

  Set, Administration, Intravascular
  1 report

Recent MiniMed Mio Advance adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  It was reported by the patient that the tape not sticking due to sweating on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951640 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951639 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  It was reported by the patient that the tape not sticking on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951633 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  It was reported that patient faced an event where tape was not sticking due to weather on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951064 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951058 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951048 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  It was reported that patient faced an event where infusion set fell off due to tape was not sticking on (b)(6)2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951047 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950861 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950650 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950493 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950486 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  It was reported that patient experienced an event on (b)(6) 2026 in which infusion set tape was not sticking and fell off.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950468 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient experienced high blood glucose event on (b)(6) 2026 and treated it with manual injection.

  Patient problems: Hyperglycemia

  MAUDE report 50950463 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  It was reported that patient experienced an event on (b)(6) 2026 in which infusion set tape was not located at the insertion site.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950462 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  It was reported that patient experienced an event on (b)(6) 2026 in which infusion set fell off due to exposed to moisture while taking a bath.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950457 ↗

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