PowerPort M.R.I., ChronoFlex 1808071Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741027086), received between Sep 25, 2018 and Mar 25, 2026 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24684315 ↗
• InjuryJun 10, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT APPROXIMATELY FIVE YEARS, THREE MONTHS AND THIRTEEN DAYS POST PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED ACUTE EMBOLISM AND THROMBOSIS OF RIGHT INTERNAL JUGULAR VEIN. THE DEVICE WAS REMOVED FROM THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Embolism/Embolus; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22173722 ↗
• InjuryOct 1, 2024Expulsion; Expulsion

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED AN INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED SKIN EROSION AT THE PORT SITE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Skin Erosion; Unspecified Infection

  MAUDE report 20340983 ↗
• DeathDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT THREE MONTHS AND NINE DAYS POST A PORT PLACEMENT, THE PATIENT DEVELOPED INFECTION AND SEPSIS. IT WAS FURTHER REPORTED THAT PATIENT WAS EXPIRED. THE CAUSE OF THE PATIENT¿S DEATH WAS SEVERE SEPSIS WITH SEPTIC SHOCK AND INFECTED LEFT SUBCLAVIAN PORT. NO OTHER PERTINENT PATIENT, DEVICE OR MEDICAL INFORMATION WAS PROVIDED LEADING UP TO OR SURROUNDING THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacteremia; Sepsis; Septic Shock; Unspecified Infection

  MAUDE report 18388441 ↗
• MalfunctionSep 25, 2018Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PATIENT HAS A POWERPORT AND THE NURSE ATTEMPTED TO PERFORM ROUTINE FLUSHING, HOWEVER THE PORT WOULD NOT FLUSH AND THE NURSE WAS NOT ABLE TO GET BLOOD RETURN. THE PATIENT WAS SEEN AGAIN APPROXIMATELY TWO DAYS LATER AND HER POSITIONING WAS CHANGED FROM SUPINE TO SITTING AND THE PORT WAS ABLE TO BE FLUSHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7907941 ↗