MiniMed Infusion SetsRecalls & reported problems across all models
Unomedical A/S · 58 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 30,240
- Deaths reported
- 80
- Injuries reported
- 11,649
- Recalls
- 0
We found 58 models of MiniMed Infusion Sets by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 30,240 adverse event reports in the FDA's MAUDE database, received between Jan 29, 2020 and Sep 30, 2026 — classified as 80 deaths, 11,649 injuries, 18,511 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (7,751 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
Reports received per month, all models
Most reported MiniMed Infusion Sets problems
Device problems
- Loss of or Failure to Bond7,751
- Premature Separation7,606
- Adverse Event Without Identified Device or Use Problem6,362
- Material Twisted/Bent3,914
- Leak/Splash2,531
- Detachment of Device or Device Component1,979
- Complete Blockage1,703
- Infusion or Flow Problem1,455
Patient problems
- No Clinical Signs, Symptoms or Conditions16,475
- Hyperglycemia9,748
- Elevated Ketones/ Diabetic Ketoacidosis2,125
- Hypoglycemia1,607
- Hemorrhage/Blood Loss/Bleeding246
- Vomiting233
- Headache125
- Nausea114
MiniMed Infusion Sets models
58 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Minimed™ Quick-set™ MMT-399ASet, Administration, Intravascular9 deaths8,669 reports
- MiniMed™ Mio™ Advance MMT-242ASet, Administration, Intravascular15 deaths8,164 reports
- Minimed™ Quick-set™ MMT-397ASet, Administration, Intravascular19 deaths4,134 reports
- Minimed™ Quick-set™ MMT-396ASet, Administration, Intravascular10 deaths1,672 reports
- MiniMed™ Mio™ Advance MMT-243ASet, Administration, Intravascular3 deaths1,563 reports
- MiniMed™ Sure T™ MMT-864ASet, Administration, Intravascular755 reports
- Minimed™ Quick-set™ MMT-398ASet, Administration, Intravascular3 deaths685 reports
- MiniMed™ Mio™ Advance MMT-213ASet, Administration, Intravascular4 deaths532 reports
- MiniMed™ Silhouette™ MMT-381ASet, Administration, Intravascular2 deaths496 reports
- Minimed™ Quick-set™ MMT-387ASet, Administration, Intravascular468 reports
- Minimed™ Quick-set™ MMT-386ASet, Administration, Intravascular2 deaths411 reports
- MiniMed™ Mio™ Advance MMT-244ASet, Administration, Intravascular1 death391 reports
- MiniMed™ Mio™ Advance MMT-242ATSet, Administration, Intravascular298 reports
- Minimed™ Quick-set™ MMT-394ASet, Administration, Intravascular1 death274 reports
- MiniMed™ Sure T™ MMT866ASet, Administration, Intravascular2 deaths234 reports
- MiniMed™ Sure T™ MMT-874ASet, Administration, Intravascular133 reports
- MiniMed™ Silhouette™ MMT-378ASet, Administration, Intravascular3 deaths131 reports
- Minimed™ Mio™ MMT-943ASet, Administration, Intravascular1 death108 reports
- MiniMed™ Silhouette™ MMT-382ASet, Administration, Intravascular93 reports
- Minimed™ Quick-set™ MMT-399ASet, Administration, Intravascular89 reports
- MiniMed™ Sure T™ MMT-876ASet, Administration, Intravascular85 reports
- MiniMed™ Mio™ Advance MMT-243ATSet, Administration, Intravascular81 reports
- Minimed™ Mio™ MMT-975ASet, Administration, Intravascular80 reports
- Minimed™ Quick-set™ MMT-397ATSet, Administration, Intravascular2 deaths77 reports
- MiniMed™ Sure T™ MMT-862ASet, Administration, Intravascular72 reports
- MiniMed™ Silhouette™ MMT-377ASet, Administration, Intravascular69 reports
- MiniMed™ Silhouette™ MMT-383ASet, Administration, Intravascular56 reports
- MiniMed™ Silhouette™ MMT-368ASet, Administration, Intravascular1 death52 reports
- MiniMed™ Mio™ Advance MMT-242Set, Administration, Intravascular1 death50 reports
- Minimed™ Mio™ MMT-923ASet, Administration, Intravascular1 death40 reports
- MiniMed™ Sure T™ MMT-886ASet, Administration, Intravascular31 reports
- Minimed™ Mio™ MMT-941A600Set, Administration, Intravascular30 reports
- Minimed™ Quick-set™ MMT-397ASet, Administration, Intravascular29 reports
- Minimed™ Mio™ MMT-943A600Set, Administration, Intravascular20 reports
- Minimed™ Mio™ MMT-921ASet, Administration, Intravascular19 reports
- Minimed™ Quick-set™ MMT-396ASet, Administration, Intravascular18 reports
- Minimed™ Mio™ MMT-965A600Set, Administration, Intravascular13 reports
- MiniMed™ Silhouette™ MMT-384ASet, Administration, Intravascular12 reports
- Minimed™ Mio™ MMT-941ASet, Administration, Intravascular10 reports
- Minimed™ Quick-set™ MMT-396ATSet, Administration, Intravascular10 reports
- Minimed™ Mio™ MMT-925ASet, Administration, Intravascular9 reports
- MiniMed™ Sure T™ MMT-884ASet, Administration, Intravascular8 reports
- Minimed™ Mio™ MMT-975A600Set, Administration, Intravascular8 reports
- Minimed™ Quick-set™ MMT-399ASet, Administration, Intravascular7 reports
- Minimed™ Quick-set™ MMT-398ASet, Administration, Intravascular7 reports
- Minimed™ Mio™ MMT-923A600Set, Administration, Intravascular7 reports
- MiniMed™ Mio™ Advance MMT-242TSet, Administration, Intravascular6 reports
- Minimed™ Mio™ MMT-945A600Set, Administration, Intravascular6 reports
- MiniMed™ Mio™ Advance MMT-213Set, Administration, Intravascular5 reports
- Minimed™ Mio™ MMT-965ASet, Administration, Intravascular5 reports
- Minimed™ Mio™ MMT-921A600Set, Administration, Intravascular5 reports
- Minimed™ Quick-set™ MMT-397ASet, Administration, Intravascular3 reports
- Minimed™ Quick-set™ MMT-396ASet, Administration, Intravascular3 reports
- MiniMed™ Mio™ Advance MMT-243Set, Administration, Intravascular2 reports
- Minimed™ Quick-set™ MMT-386ASet, Administration, Intravascular2 reports
- MiniMed™ Mio™ Advance MMT-231Set, Administration, Intravascular1 report
- Minimed™ Quick-set™ MMT-394ASet, Administration, Intravascular1 report
- MiniMed™ Mio™ Advance MMT-242Set, Administration, Intravascular1 report
Recent MiniMed Infusion Sets 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 50951641 ↗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
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951638 ↗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
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 ↗
Other Unomedical A/S products
- Autosoft XC11 models · 31,720 reports
- Medtronic Extended27 models · 22,785 reports
- Autosoft9021 models · 20,579 reports · 1 recall
- Minimed Quick-set18 models · 16,559 reports
- MiniMed Mio Advance12 models · 11,094 reports
- TruSteel5 models · 4,387 reports
- Autosoft307 models · 3,945 reports
- inset13 models · 2,869 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered, combining the brand names used for this product line.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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