PowerPort M.R.I., Groshong 4808561Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741027352), received between Jul 18, 2019 and Jan 6, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryJan 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE MONTH AND EIGHTEEN DAYS POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED SMALL CLUSTER OF PORT INFECTIONS. REPORTEDLY, THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18461135 ↗
• InjuryJan 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO MONTHS AND TWENTY-TWO DAYS POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED SMALL CLUSTER OF PORT INFECTIONS. REPORTEDLY, THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18461126 ↗
• InjuryJan 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE PORT ALLEGEDLY HAD SMALL CLUSTER OF INFECTION. REPORTEDLY, THE PORT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 18461123 ↗
• InjuryFeb 18, 2021Fracture; Material Separation; Deformation Due to Compressive Stress; Fracture; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING PORT PLACEMENT PROCEDURE, THE FLUOROSCOPE DEMONSTRATED THAT THE PORT ALLEGEDLY BROKE AND GUIDE WIRE FRACTURED. IT WAS FURTHER REPORTED THAT BROKEN PIECES RETAINED IN SVC/RIGHT ATRIUM WERE REMOVED FROM THE PATIENT. REPORTEDLY ADDITIONAL FLUOROSCOPE TECHNIQUE WAS USED TO REMOVE THE CATHETER FROM THE PATIENT. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11341804 ↗
• MalfunctionJul 18, 2019Break; Break

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 4808561. IMPLANTABLE PORT ALLEGEDLY EXPERIENCED BREAK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT IS 77 YEARS OF AGE, THE GENDER IS MALE; HOWEVER, THE WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8803043 ↗