I-port Advance MMT-101TRecalls & 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
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 05705244009370), received between Feb 20, 2025 and May 24, 2026 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (14 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
- Material Twisted/Bent14
- Partial Blockage11
- Leak/Splash4
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 24, 2026Fluid/Blood Leak
IT WAS REPORTED THAT PATIENT EXPERIENCED LEAKAGE ISSUE ON (B)(6) 2026, MEDICATION LEAKED AT TOP OF THE SEPTUM AND THE LEAK IN THE TRANSPARENT BODY OF DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25266988 ↗MalfunctionMay 23, 2026Leak/Splash
IT WAS REPORTED THAT THERE WAS LEAKAGE AT TOP OF THE SEPTUM IN THE TRANSPARENT BODY OF THE DEVICE ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264894 ↗MalfunctionMay 23, 2026Leak/Splash
IT WAS REPORTED THAT THERE WAS LEAKAGE AT TOP OF THE SEPTUM IN THE TRANSPARENT BODY OF THE DEVICE ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264867 ↗MalfunctionMay 23, 2026Leak/Splash
IT WAS REPORTED THAT THERE WAS LEAKAGE AT TOP OF THE SEPTUM IN THE TRANSPARENT BODY OF THE DEVICE ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264829 ↗MalfunctionApr 21, 2026Partial Blockage; Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BENT CANNULA AND LEAKAGE AT THE ADHESIVE ON 23 MAR 2026 AS THE LEAKAGE OCCURRED DUE TO THE BENT CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24935269 ↗MalfunctionApr 21, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BENT CANNULA AND LEAKAGE AT THE ADHESIVE ON (B)(6) 2026 AS THE LEAKAGE OCCURRED DUE TO THE BENT CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24935182 ↗MalfunctionApr 21, 2026Partial Blockage; Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BENT CANNULA AND LEAKAGE AT THE ADHESIVE ON (B)(6) 2026 AS THE LEAKAGE OCCURRED DUE TO THE BENT CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24935179 ↗MalfunctionApr 21, 2026Partial Blockage; Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BENT CANNULA AND LEAKAGE AT THE ADHESIVE ON (B)(6) 2026 AS THE LEAKAGE OCCURRED DUE TO THE BENT CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24935175 ↗MalfunctionApr 21, 2026Partial Blockage; Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BENT CANNULA AND LEAKAGE AT THE ADHESIVE ON (B)(6) 2026 AS THE LEAKAGE OCCURRED DUE TO THE BENT CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24935107 ↗MalfunctionApr 21, 2026Partial Blockage; Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BENT CANNULA AND LEAKAGE AT THE ADHESIVE ON 23 MAR 2026 AS THE LEAKAGE OCCURRED DUE TO THE BENT CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24935103 ↗MalfunctionApr 21, 2026Partial Blockage; Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BENT CANNULA AND LEAKAGE AT THE ADHESIVE ON (B)(6) 2026 AS THE LEAKAGE OCCURRED DUE TO THE BENT CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24935099 ↗MalfunctionApr 21, 2026Partial Blockage; Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BENT CANNULA AND LEAKAGE AT THE ADHESIVE ON (B)(6) 2026 AS THE LEAKAGE OCCURRED DUE TO THE BENT CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24935093 ↗MalfunctionApr 21, 2026Partial Blockage; Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BENT CANNULA AND LEAKAGE AT THE ADHESIVE ON (B)(6) 2026 AS THE LEAKAGE OCCURRED DUE TO THE BENT CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24935021 ↗MalfunctionApr 21, 2026Partial Blockage; Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BENT CANNULA AND LEAKAGE AT THE ADHESIVE ON (B)(6) 2026 AS THE LEAKAGE OCCURRED DUE TO THE BENT CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24934959 ↗MalfunctionApr 21, 2026Partial Blockage; Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BENT CANNULA AND LEAKAGE AT THE ADHESIVE ON (B)(6) 2026 AS THE LEAKAGE OCCURRED DUE TO THE BENT CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24934889 ↗MalfunctionApr 21, 2026Partial Blockage; Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BENT CANNULA AND LEAKAGE AT THE ADHESIVE ON (B)(6) 2026 AS THE LEAKAGE OCCURRED DUE TO THE BENT CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24934824 ↗MalfunctionApr 21, 2026Material Twisted/Bent
IT WAS REPORTED THAT PATIENT FACED BENT CANNULA ISSUE, LEADING TO LEAKAGE ON 23-MAR-2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24934669 ↗MalfunctionApr 21, 2026Material Twisted/Bent
IT WAS REPORTED THAT PATIENT FACED BENT CANNULA ISSUE, LEADING TO LEAKAGE ON 23-MAR-2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24934638 ↗MalfunctionFeb 20, 2025Leak/Splash; Leak/Splash
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN NETHERLANDS IT WAS REPORTED THAT PATIENT FACED INJECTION PORT LEAK EVENT ON (B)(6) 2025. THE LEAKAGE WAS FROM THE BODY DEVICE. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21418392 ↗
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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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