Minimed™ Mio™ MMT-975ARecalls & reported problems
Unomedical A/S · Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use. · Class 2
All models of MiniMed Infusion Sets (58) · Minimed Mio (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a MiniMed Mio MMT-975A, a single-use infusion set for subcutaneous insulin delivery. The 76 reports mostly describe the soft tubing twisting or bending, infusion or flow problems, and parts coming apart or leaking at the insertion site, which several patients say led to high blood sugar, ketones, or diabetic ketoacidosis needing treatment with an insulin pen. No deaths and 33 injuries were reported. No recalls name this device. Reports in the last 12 months (8) are far fewer than the 33 in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 80
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 05705244020160), received between Jun 25, 2020 and Sep 18, 2026 — classified as 36 injuries, 44 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (20 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent20
- Infusion or Flow Problem14
- Detachment of Device or Device Component11
- Adverse Event Without Identified Device or Use Problem9
- Leak/Splash9
- No Apparent Adverse Event8
- Device Handling Problem3
- Loss of or Failure to Bond3
Patient problems
- Hyperglycemia25
- No Clinical Signs, Symptoms or Conditions25
- Elevated Ketones/ Diabetic Ketoacidosis23
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Hypoglycemia3
- Fatigue2
- Vomiting2
- Dizziness1
Recent adverse event reports
The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Loss of or Failure to Bond; Leak/Splash; Premature Separation
Patient problems: Hyperglycemia
MAUDE report 50821080 ↗MalfunctionSep 5, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50628828 ↗InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient was hospitalized due to elevated blood glucose levels of 200 mg/dl and elevated ketone levels event on (b)(6) 2026 and was treated with intravenous insulin.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50537901 ↗InjuryAug 25, 2026Leak/Splash
Patient reported infusion set was leaking at site led to high blood glucose event and was treated with pump event occurred on(b)(6) 2024.
Patient problems: Hyperglycemia
MAUDE report 50430810 ↗InjuryAug 21, 2026Leak/Splash
It was reported that patient faced an infusion set leak at site events on (b)(6) 2024 which led to high blood glucose and it was treated with insulin pump.
Patient problems: Hyperglycemia
MAUDE report 50370603 ↗InjuryAug 18, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set tubing was leaking at site of insertion on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50294189 ↗InjuryAug 11, 2026Complete Blockage
Patient problems: Hyperglycemia
MAUDE report 50207037 ↗InjuryAug 8, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50185073 ↗InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient had high blood glucose and treated with insulin pen on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50151503 ↗InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient had high blood glucose and treated with insulin pen on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50151490 ↗InjuryAug 5, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient faced an event where soft cannula was found bent after removal from the infusion site, which led to high blood glucose above 400 mg/dL, which was managed using the pump on (b)(6) 2025.
Patient problems: Hyperglycemia
MAUDE report 50145860 ↗InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD HIGH BLOOD GLUCOSE LEVELS AND WAS TREATED WITH INSULIN PEN ON (B)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 24936019 ↗InjuryOct 12, 2025Material Twisted/Bent; Material Twisted/Bent
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BENT CANNULA EVENT ON (B)(6) 2024 AND FURTHER WENT TO AN EMERGENCY ROOM (ER) AND EVENTUALLY GOT HOSPITALIZED DUE TO HYPERGLYCEMIA AND HIGH KETONES. BLOOD GLUCOSE LEVEL WAS 570 MG/DL AT THE TIME OF THE EVENT AND PATIENT GOT TREATED WITH INTRAVENOUS INSULIN (IV). THE DURATION OF HOSPITALIZATION WAS TWO DAYS. THE INSERTION SITE WAS THIGH. THE INFUSION SET WAS IN USE FOR TWO DAYS. KETONE LEVEL WAS 3 MMOL/L. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 23275081 ↗MalfunctionSep 12, 2025Infusion or Flow Problem; Infusion or Flow Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23034932 ↗InjuryAug 8, 2025Material Twisted/Bent; Material Twisted/Bent
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BENT CANNULA ON (B)(6) 2025 LEADING TO HIGH BLOOD GLUCOSE (425 MG/DL) AND EMERGENCY ROOM VISIT. THE DURATION OF STAY WAS LESS THAN ONE HOUR. PATIENT REPORTED SYMPTOMS OF STOMACHACHE AND THROWING UP. DURING HOSPITALIZATION, PATIENT RECEIVED MANUAL INJECTION AS A CORRECTIVE TREATMENT. COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 22746541 ↗MalfunctionAug 7, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22735359 ↗InjuryJul 21, 2025Leak/Splash; Leak/Splash
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED ARAB EMIRATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6) 2025 THE LEAKAGE WAS IN THE CANNULA SITE. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT WAS TREATED WITH CORRECTION BOLUS VIA PUMP. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Hyperglycemia
MAUDE report 22552688 ↗MalfunctionJul 18, 2025Infusion or Flow Problem; Infusion or Flow Problem
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT FACED AN INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22539203 ↗InjuryJul 17, 2025No Apparent Adverse Event; No Apparent Adverse Event
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 22528106 ↗InjuryJun 18, 2025Material Twisted/Bent; Material Twisted/Bent
REFERENCE NUMBER (B)(4) EVENT OCCURRED IN UNITED ARAB EMIRATES. IT WAS REPORTED THAT PATIENT WENT TO AN EMERGENCY ROOM AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA EVENT AND BENT CANNULA EVENT. INFUSION SET WAS USED FOR ONE DAY. THE INSERTION SITE WAS THE ABDOMEN. BLOOD GLUCOSE LEVEL WAS 399 MG/DL AT THE TIME OF THE EVENT. THE DURATION OF HOSPITALIZATION WAS LESS THAN 24 HOURS. PATIENT GOT TREATED WITH INSULIN VIA MANUAL INJECTION. PATIENT WAS ALSO EXPERIENCED THE SYMPTOMS OF SICK/UNWELL AT THE TIME OF THE EVENT. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 22257630 ↗MalfunctionMay 27, 2025Leak/Splash; Leak/Splash
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EVENT OF INFUSION SET LEAKAGE ON (B)(6) 2025 LEADING TO HIGH BLOOD GLUCOSE. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Hyperglycemia
MAUDE report 22085602 ↗InjuryMay 22, 2025Material Twisted/Bent; Material Twisted/Bent
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT GOT HOSPITALIZED ON (B)(6)2025 DUE TO BENT CANNULA LEADING TO HYPERGLYCEMIA. THE BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INSULIN PEN AND SOLUTION. COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 22068767 ↗MalfunctionMay 13, 2025Device Handling Problem; Device Handling Problem
REFERENCE NUMBER (B)(4). EVENT OCCURED IN THE UNITED ARAB EMIRATES. ON (B)(6) 2025, THE PATIENT REPORTED THAT THE CANNULA OF THEIR INFUSION SET WAS TRIGGERED PREMATURELY, ACTIVATING BEFORE IT COULD BE PROPERLY INSERTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22007901 ↗MalfunctionMay 9, 2025Device Handling Problem; Device Handling Problem
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED THAT INFUSION SET CANNULA WAS FIRED BEFORE INSERTION WHICH OCCURRED ON (B)(6) 2025. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21992201 ↗MalfunctionApr 30, 2025Material Twisted/Bent; Material Twisted/Bent
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED ARAB EMIRATES. IT WAS REPORTED THAT THE CHILD PATIENT EXPERIENCED AN EVENT OF INFUSION SET BENT CANNULA ON (B)(6) 2025. THE INSERTION SITE WAS ABDOMEN. THE INFUSION SET WAS IN USE FOR LESS THAN ONE DAY. THE BLOOD GLUCOSE LEVEL WAS 500 MG/DL AND THE PATIENT WAS TREATED WITH INSULIN PUMP. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Hyperglycemia
MAUDE report 21932091 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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