I-port AdvanceRecalls & reported problems across all models

We found 4 models of I-port Advance by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 184 adverse event reports in the FDA's MAUDE database, received between Jun 5, 2017 and Jul 4, 2026 — classified as 16 injuries, 168 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (60 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported I-port Advance problems

I-port Advance models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• I-port Advance MMT-100

  Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
  141 reports
• I-port Advance MMT-101T

  Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
  19 reports
• I-port Advance MMT-100T

  Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
  15 reports
• I-port Advance MMT-101

  Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
  9 reports

Recent I-port Advance adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 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 ↗
• 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 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 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 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 ↗
• 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 ↗

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