Minimed Quick-setRecalls & reported problems across all models

We found 18 models of Minimed Quick-set by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 16,559 adverse event reports in the FDA's MAUDE database, received between Aug 5, 2020 and Sep 30, 2026 — classified as 46 deaths, 8,080 injuries, 8,433 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3,502 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 Quick-set problems

Minimed Quick-set models

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

• Minimed™ Quick-set™ MMT-399A

  Set, Administration, Intravascular
  9 deaths8,669 reports
• Minimed™ Quick-set™ MMT-397A

  Set, Administration, Intravascular
  19 deaths4,134 reports
• Minimed™ Quick-set™ MMT-396A

  Set, Administration, Intravascular
  10 deaths1,672 reports
• Minimed™ Quick-set™ MMT-398A

  Set, Administration, Intravascular
  3 deaths685 reports
• Minimed™ Quick-set™ MMT-387A

  Set, Administration, Intravascular
  468 reports
• Minimed™ Quick-set™ MMT-386A

  Set, Administration, Intravascular
  2 deaths411 reports
• Minimed™ Quick-set™ MMT-394A

  Set, Administration, Intravascular
  1 death274 reports
• Minimed™ Quick-set™ MMT-399A

  Set, Administration, Intravascular
  89 reports
• Minimed™ Quick-set™ MMT-397AT

  Set, Administration, Intravascular
  2 deaths77 reports
• Minimed™ Quick-set™ MMT-397A

  Set, Administration, Intravascular
  29 reports
• Minimed™ Quick-set™ MMT-396A

  Set, Administration, Intravascular
  18 reports
• Minimed™ Quick-set™ MMT-396AT

  Set, Administration, Intravascular
  10 reports
• Minimed™ Quick-set™ MMT-399A

  Set, Administration, Intravascular
  7 reports
• Minimed™ Quick-set™ MMT-398A

  Set, Administration, Intravascular
  7 reports
• Minimed™ Quick-set™ MMT-397A

  Set, Administration, Intravascular
  3 reports
• Minimed™ Quick-set™ MMT-396A

  Set, Administration, Intravascular
  3 reports
• Minimed™ Quick-set™ MMT-386A

  Set, Administration, Intravascular
  2 reports
• Minimed™ Quick-set™ MMT-394A

  Set, Administration, Intravascular
  1 report

Recent Minimed Quick-set adverse event reports

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

• InjurySep 30, 2026Fluid/Blood Leak

  Patient problems: Hyperglycemia

  MAUDE report 50951924 ↗
• InjurySep 30, 2026Fluid/Blood Leak

  Patient problems: Hyperglycemia

  MAUDE report 50951808 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951638 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951555 ↗
• InjurySep 30, 2026Fluid/Blood Leak

  Patient problems: Hyperglycemia

  MAUDE report 50951537 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951377 ↗
• 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)(4) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951374 ↗
• InjurySep 30, 2026Complete Blockage; Material Twisted/Bent

  It was reported that the patient experienced high blood glucose (BG) of 420 mg/dL after the cannula was found bent. The high blood sugar was managed and treated with insulin delivered via the insulin pump.

  Patient problems: Hyperglycemia

  MAUDE report 50951267 ↗
• InjurySep 30, 2026Complete Blockage; Material Twisted/Bent

  It was reported that the patient experienced high blood glucose of 437 mg/dL after the cannula was found bent on (b)(6) 2026. The high blood sugar was managed and treated with a correction bolus delivered via the insulin pump.

  Patient problems: Hyperglycemia

  MAUDE report 50951265 ↗
• InjurySep 30, 2026Complete Blockage; Material Twisted/Bent

  It was reported that the patient experienced a bent cannula event on (b)(6)2026 that resulted in high blood glucose. The high blood sugar was managed and treated with a bolus.

  Patient problems: Hyperglycemia

  MAUDE report 50951264 ↗
• InjurySep 30, 2026Complete Blockage; Material Twisted/Bent

  Patient problems: Hyperglycemia

  MAUDE report 50951262 ↗
• InjurySep 30, 2026Complete Blockage; Material Twisted/Bent

  Patient problems: Hyperglycemia

  MAUDE report 50951082 ↗
• InjurySep 30, 2026Complete Blockage; Material Twisted/Bent

  Patient problems: Hyperglycemia

  MAUDE report 50951079 ↗
• InjurySep 30, 2026Complete Blockage; Material Twisted/Bent

  Patient problems: Hyperglycemia

  MAUDE report 50951076 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950869 ↗

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