I-port Advance MMT-100Recalls & 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 injection port has 168 reports, with no deaths and 15 injuries. Many reports describe leaks, bent cannulas or needles, and adhesive that did not stick or came apart early. Some mention high blood sugar after a leak. No recalls name this device, and reports rose from 50 in the prior 12 months to 82 in the latest 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
- 141
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 141 adverse event reports that list this exact device (DI 05705244009394), received between Jun 6, 2017 and Jun 27, 2026 — classified as 14 injuries, 127 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (53 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
- Leak/Splash53
- Loss of or Failure to Bond46
- Premature Separation35
- Material Twisted/Bent19
- Device Handling Problem4
- Fluid/Blood Leak4
- Adverse Event Without Identified Device or Use Problem2
- Complete Blockage2
Patient problems
- No Clinical Signs, Symptoms or Conditions91
- Hyperglycemia34
- Elevated Ketones/ Diabetic Ketoacidosis10
- Nausea5
- Pain4
- Abdominal Pain3
- Dyspnea2
- Headache2
Recent adverse event reports
The 25 most recent of 141 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT TAPE NOT STICKING ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25645516 ↗InjuryJun 26, 2026Complete Blockage
IT WAS REPORTED THAT PATIENT FACED PATIENT HAD HIGH BLOOD GLUCOSE AND HAD SYMPTOMS OF VOMITING, NAUSEA AND PATIENT WAS NOT ADMITTED AS AN INPATIENT FOR MEDICAL TREATMENT AND CANNULA WAS BENT ON (B)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 25638197 ↗MalfunctionJun 26, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT FACED AN EVENT WHERE TAPE DID NOT STICK ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25636088 ↗MalfunctionJun 22, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE INFUSION SET TAPE DID NOT STICK TO THE SITE ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25579803 ↗InjuryJun 22, 2026Complete Blockage
IT WAS REPORTED THAT PATIENT EXPERIENCED BENT CANNULA EVENT ON (B)(6) 2026 AND HAD HIGH BLOOD GLUCOSE LEVEL AND IT WAS ADDRESSED BY INSULIN PENS.
Patient problems: Hyperglycemia
MAUDE report 25573383 ↗MalfunctionJun 16, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT HAD AN ISSUE WITH BENT CANNULA AND EXPERIENCED SYMPTOMS OF NAUSEA, VOMITING, ABDOMINAL PAIN, AND DIFFICULTY BREATHING ON (B)(6) 2025 ASSOCIATED WITH HIGH BLOOD GLUCOSE AND POSITIVE KETONES.
Patient problems: Abdominal Pain; Dyspnea; Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Nausea; Vomiting
MAUDE report 25514388 ↗MalfunctionJun 7, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE INFUSION SET TAPE FAILED TO ADHERE AND FELL FROM THE BODY ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25421740 ↗MalfunctionJun 7, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE INFUSION SET TAPE FAILED TO ADHERE AND FELL FROM THE BODY ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25421704 ↗MalfunctionJun 7, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE INFUSION SET TAPE FAILED TO ADHERE AND FELL FROM THE BODY ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25421669 ↗MalfunctionJun 7, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE INFUSION SET TAPE FAILED TO ADHERE AND FELL FROM THE BODY ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25421633 ↗MalfunctionMay 23, 2026Material Twisted/Bent
IT WAS REPORTED THAT PATIENT FACED INFUSION SET CANNULA BENT EVENT ON (B)(6) 2026. THE BLOOD GLUCOSE LEVEL WAS HIGH.
Patient problems: Hyperglycemia
MAUDE report 25264125 ↗MalfunctionMay 20, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT PATIENT REPORTED AN EVENT WHERE INFUSION SET TAPE IS NOT STICKING ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25237613 ↗MalfunctionMay 14, 2026Leak/Splash
IT WAS REPORTED THAT INJECTION PORT LEAKAGE AT TOP OF SEPTUM AND PATIENT HAD HIGH BLOOD GLUCOSE LEVELS ON (B)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 25170301 ↗MalfunctionMay 7, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT FACED SIX INFUSION SETS WERE UNTAPED BACK TO BACK AFTER TWENTY FOUR HOURS OF WEAR EVENT ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25108718 ↗MalfunctionMay 7, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT FACED SIX INFUSION SETS WERE UNTAPED BACK-TO-BACK AFTER TWENTY-FOUR HOURS OF WEAR EVENT ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25108714 ↗MalfunctionMay 7, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT FACED SIX INFUSION SETS WERE UNTAPED BACK TO BACK AFTER TWENTY FOUR HOURS OF WEAR EVENT ON 30 MAR 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25108712 ↗MalfunctionMay 7, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT FACED SIX INFUSION SETS WERE UNTAPED BACK-TO-BACK AFTER TWENTY-FOUR HOURS OF WEAR EVENT ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25108711 ↗MalfunctionMay 7, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT FACED SIX INFUSION SETS WERE UNTAPED BACK TO BACK AFTER TWENTY FOUR HOURS OF WEAR EVENT ON 30 MAR 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25108709 ↗MalfunctionMay 7, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT FACED SIX INFUSION SETS WERE UNTAPED BACK TO BACK AFTER TWENTY FOUR HOURS OF WEAR EVENT ON 30 MAR 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25108704 ↗MalfunctionMay 7, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIX INFUSION SETS DETACHED IN TWENTY FOUR HOURS DUE TO TAPE NOT STICKING ISSUE EVENT ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25108181 ↗MalfunctionMay 7, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIX INFUSION SETS DETACHED BACK TO BACK IN TWENTY FOUR HOURS DUE TO TAPE NOT STICKING ISSUE EVENT ON 01 APR 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25108179 ↗MalfunctionMay 7, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIX INFUSION SETS DETACHED IN TWENTY FOUR HOURS DUE TO TAPE NOT STICKING ISSUE EVENT ON 03 APR 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25108174 ↗MalfunctionMay 7, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIX INFUSION SETS DETACHED BACK TO BACK IN TWENTY FOUR HOURS DUE TO TAPE NOT STICKING ISSUE EVENT ON (B)(6) 2026.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25108172 ↗MalfunctionApr 24, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT REPORTED TAPE WAS NOT STICKING DUE TO NOT ENOUGH STICK AND KEEP FALLING OFF ON (B)(6) 2026, HENCE NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24984417 ↗MalfunctionApr 24, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE INFUSION SET TAPE DID NOT ADHERE AS IT FELL OFF FROM THE BODY ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24977220 ↗
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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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