I-port Advance MMT-101Recalls & reported problems
Unomedical A/S · Single use injection port for subcutaneous injection. The injection port must be used as described in the Instruction for Use. · Class 2
All models of I-port Advance (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05705244009417), received between Jun 7, 2024 and May 15, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (5 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
- Premature Separation5
- Device Handling Problem4
- Loss of or Failure to Bond3
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2026Premature Separation
IT WAS REPORTED THAT THE PATIENT FACED AN EVENT ON (B)(6) 2026, WHERE PATIENT FACED ADHESIVE ISSUES SINCE SET FELL OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25180003 ↗MalfunctionApr 22, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT INFUSION SET TAPE WAS NOT STICKING EVENT ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24949583 ↗MalfunctionApr 22, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT INFUSION SET TAPE WAS NOT STICKING EVENT ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24949425 ↗MalfunctionApr 22, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT INFUSION SET TAPE WAS NOT STICKING EVENT ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24949377 ↗MalfunctionApr 22, 2026Premature Separation
IT IS REPORTED THAT THE PATIENT FACED AN ADHESIVE ISSUE ON (B)(6) 2026 AS TAPE WAS NOT STICKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24949160 ↗MalfunctionJan 27, 2025Device Handling Problem; Device Handling Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21238428 ↗MalfunctionJun 7, 2024Device Handling Problem; Device Handling Problem
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED KINGDOM. IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT EXPERIENCED AN ISSUE WITH THE I-PORT NOT BEING INSERTED PROPERLY AND NOT STAYING IN PLACE. THE PATIENT IS USING THE I-PORT ADVANCE TO DELIVER INSULIN FOR TREATING DIABETES MELLITUS. THE I-PORT ADVANCE HAS BEEN IN USE FOR 2 HOURS. THE PATIENT REPORTED THAT THE I-PORT HAS A SLIGHT BEND. THE PATIENT WAS ADVISED THAT A LONGER CANNULA MAY BEND AGAINST MUSCLE ON LEAN PATIENTS AND THAT IF THE NEEDLE IS REMOVED WHEN THE INJECTION PORT IS NOT FLUSH WITH THE SKIN, IT CAN LOSE RIGIDITY AND SUPPORT FOR THE CANNULA. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19491731 ↗MalfunctionJun 7, 2024Device Handling Problem; Device Handling Problem
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED KINGDOM. ON (B)(6) 2024, IT WAS REPORTED THAT INFUSION SET CANULA WAS NOT INSERTED PROPERLY . NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19491430 ↗MalfunctionJun 7, 2024Device Handling Problem; Device Handling Problem
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED KINGDOM. ON 07-MAY-2024, IT WAS REPORTED THAT INFUSION SET CANULA WAS NOT INSERTED PROPERLY . NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19486355 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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