PowerPort M.R.I., Groshong 1808551Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741027109), received between May 18, 2018 and Sep 29, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Flush” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2025Fluid/Blood Leak; Difficult to Flush; Fracture; Material Separation; Migration; Fluid/Blood Leak; Difficult to Flush; Fracture; Material Separation; Migration

  ON (B)(6) 2024, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING POWERPORT ISP M.R.I. IMPLANTABLE PORT. SOMETIME LATER POST PORT PLACEMENT, IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY EXPERIENCED ISSUES WITH FLUSHING. IT WAS FURTHER REPORTED THAT THE CATHETER WAS FOUND TO BE FRACTURED. REPORTEDLY, THE CATHETER WAS MIGRATED INTO THE PATIENT'S HEART. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Extravasation; Pain; Swelling/ Edema

  MAUDE report 23164831 ↗
• InjurySep 29, 2025Difficult to Flush; Fracture; Material Separation; Migration; Difficult to Flush; Fracture; Material Separation; Migration

  ON (B)(6) 2024, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING POWERPORT ISP M.R.I. IMPLANTABLE PORT. SOMETIME LATER POST PORT PLACEMENT, IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY EXPERIENCED ISSUES WITH FLUSHING. IT WAS FURTHER REPORTED THAT THE CATHETER WAS FOUND TO BE FRACTURED. REPORTEDLY, THE CATHETER WAS MIGRATED INTO THE PATIENT'S HEART. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Swelling/ Edema

  MAUDE report 23164806 ↗
• InjuryAug 8, 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 22748255 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT FIVE YEARS, ONE MONTH, AND TWENTY-SEVEN DAYS POST A PORT PLACEMENT, BLOOD CULTURE TEST SHOWED THAT THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH A BACTERIAL BLOOD INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT WAS STARTED ON A ROUND OF ANTIBIOTICS TO TREAT THE INFECTION; HOWEVER, THE INFECTION DID NOT CLEARED. FURTHERMORE, THE BLOOD CULTURES DRAWN FROM THE PATIENT'S PORT ALLEGEDLY REMAINED POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS BACTEREMIA. REPORTEDLY, THE PATIENT UNDERWENT REMOVAL OF THE INFECTED PORT AND WAS TREATED WITH ANOTHER ROUND OF ANTIBIOTICS TO CLEAR THE INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 19453949 ↗
• MalfunctionNov 4, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY MISPLACED. IT WAS FURTHER REPORTED THAT ARTERY WAS ALLEGEDLY ACCESSED MISTAKENLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15725450 ↗
• MalfunctionOct 18, 2019Component Missing; Component Missing

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1808551 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED A MISSING COMPONENT. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. NO PATIENTS WERE INVOLVED AND PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9211144 ↗
• MalfunctionMay 18, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE TUNNELER WAS SEALED INTO THE PLASTIC. THE DEVICE WAS NOT USED ON A PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 7526458 ↗