Medtronic Extended MMT-433AJRecalls & 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 Medtronic Extended (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05705244022980), received between Jul 7, 2024 and Sep 24, 2026 — classified as 2 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond3
- Premature Separation3
- Detachment of Device or Device Component2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Material Twisted/Bent1
Patient problems
- Hyperglycemia4
- No Clinical Signs, Symptoms or Conditions3
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50887644 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50887637 ↗InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced high blood glucose event on (b)(6) 2026 and it was corrected by insulin.
Patient problems: Hyperglycemia
MAUDE report 50469898 ↗InjuryApr 13, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED THE INSULIN FLOW BLOCK ALARM AND THIS HAD LED TO A HIGH BLOOD GLUCOSE EVENT ON (B)(6) 2026. THE HIGH BLOOD GLUCOSE HAD BEEN TREATED VIA BOLUS DELIVERY.
Patient problems: Hyperglycemia
MAUDE report 24858851 ↗MalfunctionMar 17, 2026Material Twisted/Bent
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED BENT CANNULA EVENT ON (B)(6) 2026.THE INFUSION SET WAS IN USE FOR ONE HOUR. THE PATIENT ALSO EXPERIENCED BLEEDING AT INFUSION INSERTION SITE. THE INSERTION SITE WAS ABDOMEN. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERY SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24614664 ↗MalfunctionMar 13, 2026Loss of or Failure to Bond; Premature Separation
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ADHESIVE FAILURE EVENT ON 24-FEB-2026, AS THE INFUION SET TAPE FELL OFF AFTER TAKING A SHOWER. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24589538 ↗MalfunctionJul 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON 27-OCT-2022, IT WAS REPORTED THAT PATIENT FACED EVENT OF INFUSION SET TUBING DETACHED FROM TUBING-TUBING CONNECTOR. THE BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF EVENT THEREFORE THE PATIENT WAS TREATED WITH CORRECTION BLOUS VIA PUMP. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Hyperglycemia
MAUDE report 19686363 ↗MalfunctionJul 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 27-OCT-2022, IT WAS REPORTED THAT PATIENT FACED EVENT OF INFUSION SET TUBING DETACHED FROM TUBING-TUBING CONNECTOR. THE BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF EVENT THEREFORE THE PATIENT WAS TREATED WITH CORRECTION BLOUS VIA PUMP. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Hyperglycemia
MAUDE report 19686347 ↗
Other Set, Administration, Intravascular devices
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- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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