PowerPort ClearVUE 5666362Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741110733), received between Oct 18, 2018 and Mar 5, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Fracture

  A FEMALE PATIENT OF 4-YEAR-OLD PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP. SOMETIMES LATER POST PLACEMENT, ON (B)(6) 2026, IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516882 ↗
• MalfunctionJan 30, 2026Difficult to Flush; Deformation Due to Compressive Stress

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX, 6F. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS ALLEGEDLY KINKED AND COULD NOT BE FLUSHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219808 ↗
• InjuryAug 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE DEVICE MALFUNCTIONED AND THE PATIENT ALLEGEDLY DEVELOPED TACHYCARDIA. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Tachycardia

  MAUDE report 19957154 ↗
• InjuryAug 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE DEVICE MALFUNCTIONED AND THE PATIENT ALLEGEDLY DEVELOPED TACHYCARDIA. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Tachycardia

  MAUDE report 19957153 ↗
• MalfunctionNov 30, 2023Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF A PORT PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN OFF, WHEN THE PHYSICIAN ATTEMPTED TO ATTACH THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236169 ↗
• MalfunctionAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY POST PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY HAD FLUID FILLED BUMP ON THE SKIN ABOVE THE TAPE OF PORT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17649067 ↗
• MalfunctionAug 22, 2023Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT DURING THE PREPARATION OF A PORT PLACEMENT PROCEDURE, THE PORT HUB ALLEGEDLY BROKE OFF WHEN ATTEMPTED TO ATTACH THE CATHETER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17594523 ↗
• MalfunctionOct 18, 2018Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE PATIENT'S ID CARD DOES NOT STATE ANYTHING CONCERNING THE USE OF HEPARIN FLUSH AND ALSO STATES THE INCORRECT FLUSH FREQUENCY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7980026 ↗