PowerPort M.R.I., ChronoFlex 5829500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741027390), received between Oct 17, 2023 and Feb 26, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT M.R.I. DUO. SOMETIMES POST THE PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24453213 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22780338 ↗
• MalfunctionOct 17, 2023Material Integrity Problem; Material Protrusion/Extrusion; Material Integrity Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE DIAPHRAGM FOR RIGHT-SIDED LUMEN HAD BEEN PARTIALLY PULLED OUT/SEPARATED FROM THE RESERVOIR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949902 ↗