I-port Advance MMT-100TRecalls & 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
Quick summary
This Unomedical I-port Advance MMT-100T is a single-use injection port placed under the skin for subcutaneous injection. The 33 reports mostly describe the port coming apart too early or on its own, plus material twisting or bending, fluid or blood leaking from it, and the port blocking completely so nothing could be injected. Nine reports mention injuries; no deaths are described. There are no recalls naming this device. Reports rose sharply, from 3 in the previous 12 months to 27 in the most recent 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
- 15
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05705244009356), received between Jun 5, 2017 and Jul 4, 2026 — classified as 2 injuries, 13 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
- Leak/Splash3
- Fluid/Blood Leak2
- Loss of or Failure to Bond2
- Material Twisted/Bent2
- Bent1
- Complete Blockage1
- Device Handling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Hyperglycemia3
- Hemorrhage/Blood Loss/Bleeding1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 4, 2026Fluid/Blood Leak
IT WAS REPORTED THAT PATIENT EXPERIENCED AN INJECTION PORT LEAK AT THE INSERTION SITE/ADHESIVE PAD WHILE DELIVERING INSULIN EVENT ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25709565 ↗InjuryJun 27, 2026Complete Blockage; Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE DUE TO BENT CANNULA ON (B)(6) 2026. AND INSULIN WAS ADMINISTERED TO TREAT HIGH BLOOD GLUCOSE.
Patient problems: Hyperglycemia
MAUDE report 25645143 ↗MalfunctionJun 17, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET ADHESIVE NOT STICKING AT SITE WHEN APPLYING ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25528625 ↗MalfunctionJun 12, 2026Premature Separation
IT WAS REPORTED THAT PATIENT FACED ISSUES WITH INFUSION SET LOSS OF ADHESIVENESS ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25484771 ↗MalfunctionJun 12, 2026Premature Separation
IT WAS REPORTED THAT PATIENT FACED ISSUES WITH INFUSION SET LOSS OF ADHESIVENESS ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25484233 ↗MalfunctionJun 12, 2026Premature Separation
IT WAS REPORTED THAT PATIENT FACED ISSUES WITH INFUSION SET LOSS OF ADHESIVENESS ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25484232 ↗MalfunctionMay 15, 2026Leak/Splash
IT WAS REPORTED THAT PATIENT FACED AN EVENT WHERE INFUSION SET WAS LEAKING FROM SEPTUM ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25182215 ↗MalfunctionApr 7, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LEAKAGE EVENT ON 09 MAR 2026, AS THE CUSTOMER STATED THAT IPORT LEAKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24802386 ↗MalfunctionApr 6, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED THE TAPE NOT STICKING EVENT ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787589 ↗MalfunctionOct 17, 2025Material Perforation; Material Perforation
REFERENCE NUMBER (B)(4) EVENT OCCURRED IN BRAZIL. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET DAMAGED CANNULA EVENT ON (B)(6) 2025. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23322453 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN BRAZIL. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET LEAKAGE EVENT ON (B)(6) 2025. THE LEAKAGE WAS AT THE TOP OF THE SEPTUM. BLOOD GLUCOSE LEVEL WAS DISPLAYED HIGH AT THE TIME OF THE EVENT. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Hyperglycemia
MAUDE report 22696816 ↗MalfunctionNov 8, 2024Material Twisted/Bent; Material Twisted/Bent
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 30-SEPTEMBER-2024, IT WAS REPORTED BY THE PATIENT THAT INFUSION SET CANNULA WAS KINKED AND BLOOD IN THE CANNULA WITHIN TWO DAYS OF USE. INFUSION SET WAS PLACED IN ABDOMEN. 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: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20637834 ↗MalfunctionOct 16, 2024Device Handling Problem; Device Handling Problem
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN BRAZIL. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED ISSUE WITH NEEDLE GUARD. THE PATIENT WAS TREATED WITH MEDICATION BEING ADMINISTERED VIA THE INJECTION. NO FURTHER INFORMATION.
Patient problems: Hyperglycemia
MAUDE report 20460470 ↗MalfunctionMay 25, 2024Leak/Splash; Leak/Splash
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAK EVENT ON 22-APR-2024. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19398183 ↗InjuryJun 5, 2017Bent
THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 488 MG/DL. THE CUSTOMER IS USING AN IPORT AND IS HAVING HIGH BLOOD GLUCOSE. PER THE CUSTOMER'S MOTHER THE CUSTOMER RECEIVED THE IPORT AS SAMPLE, THIS IS THE FIRST TIME USING IT AND THAT THE SITE DOES NOT LOOK DAMAGE AND FULLY INSERTED INTO THE SKIN HOWEVER, AFTER THE IPORT WAS REMOVED FOUND THE CANNULA WAS BENT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6611250 ↗
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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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