PowerPort ClearVUE 1616001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741026454), received between Aug 21, 2020 and Sep 24, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Flush” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Fracture

  A patient underwent a port placement procedure using the PowerPort ClearVUE Slim. During use, the puncture needle ruptured at the junction. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881890 ↗
• MalfunctionDec 10, 2024Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE PIPELINE WAS ALLEGEDLY NOT SMOOTH. IT WAS FURTHER REPORTED THAT THE NORMAL SALINE ALLEGEDLY COULD NOT BE INJECTED SMOOTHLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20889299 ↗
• MalfunctionMay 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST PORT PLACEMENT PROCEDURE, PATIENT ALLEGEDLY EXPERIENCED EXTREME SENSITIVITY AND PAIN IN THE PORT SITE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14332439 ↗
• InjuryAug 21, 2020Inadequate User Interface; Inadequate User Interface

  IT WAS REPORTED SOME TIME POST PORT IMPLANTATION PROCEDURE, THE PALPATION BUMPS OF THE PORT ALLEGEDLY CANNOT BE FELT. IT WAS FURTHER REPORTED THAT, THE PATIENT WAS HOSPITALIZED AND COMPLETED ANTIBIOTIC TREATMENT. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Edema

  MAUDE report 10435512 ↗