PowerPort M.R.I. 1859661Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741027239), received between Feb 5, 2019 and Apr 14, 2026 — classified as 7 injuries, 2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 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 THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24872037 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT DEVELOPED PULMONARY EMBOLISM, SEPSIS, AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pulmonary Embolism; Sepsis; Thrombosis/Thrombus

  MAUDE report 24065877 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT APPROXIMATELY TWO YEARS AND THIRTY DAYS AFTER A PORT PLACEMENT, VIA THE INTERNAL JUGULAR VEIN FOR LONG-TERM IV THERAPY AND BLOOD TRANSFUSIONS, THE PATIENT WAS DIAGNOSED WITH AN INFECTED PORT. IT WAS FURTHER REPORTED THAT THE INFECTED PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24051838 ↗
• InjuryMar 19, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE PORT CATHETER ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21640097 ↗
• MalfunctionMay 14, 2024Difficult or Delayed Positioning; Difficult or Delayed Separation; Difficult or Delayed Positioning; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, WHEN SEPERATING THE BREAK AWAY SHEATH, IT ALLEGEDLY WOULD NOT BREAK OR SEPERATE. REPORTEDLY, THE PHYSICIAN HAD TO CUT IT WITH SCISSORS TO GET IT TO SEPERATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309794 ↗
• MalfunctionMar 4, 2024Fracture; Reflux within Device; Fracture; Reflux within Device

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE THE PLASTIC VALVE ON THE SHEATH WAS ALLEGEDLY FRACTURED RESULTING IN BACK BLEEDING WHICH WAS CONTROLLED WITH MANUAL PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825154 ↗
• InjuryNov 26, 2020Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT SOMETIMES POST PORT PLACEMENT, THE CATHETER ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY MIGRATED INTO THE HEART. REPORTEDLY, THE PORT WAS REMOVED. THE PATIENT IS STABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10911022 ↗
• InjuryFeb 5, 2019Break; Break

  IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS AFTER PORT-A-CATHETER PLACEMENT DURING INFUSION; THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND SWELLING. IT WAS FURTHER REPORTED THAT UNDER EVALUATION WITH RADIOLOGIST THE CATHETER ALLEGEDLY DEMONSTRATED A FRACTURE AND THE BROKEN SEGMENT WAS LOCATED IN THE SUPERIOR VENA CAVA. REPORTEDLY, A WEEK POST EVALUATION THE SEGMENT WAS REMOVED. THE FOLLOWING DAY THE PORT WAS REMOVED AND REPLACED WITHOUT COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME WITH INSTRUCTIONS TO FOLLOW UP WITH ONCOLOGIST.

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 8308460 ↗
• InjuryFeb 5, 2019Break; Break

  IT WAS REPORTED THAT APPROXIMATELY EIGHT MONTHS AFTER PORT-A-CATHETER PLACEMENT DURING A CHEST X-RAY; THE X-RAY DEMONSTRATED THE LEFT SUBCLAVIAN PORT-A-CATHETER WAS FRACTURED WITH THE DISTAL HALF OF THE CATHETER OVER THE RIGHT CARDIAC BORDER. IT WAS FURTHER REPORTED THE PORT AND THE PROXIMAL CATHETER IN LEFT CHEST WAS REMOVED WITHOUT COMPLICATIONS. REPORTEDLY, THE DISTAL SEGMENT WAS RETAINED IN THE RIGHT ATRIUM AND WAS REMOVED A FEW DAYS AFTER THE PORT WAS REMOVED. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 8308451 ↗