PowerPort M.R.I. 1809661Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741027161), received between Apr 15, 2020 and Sep 25, 2026 — classified as 1 death, 6 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• DeathSep 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. It was further reported that the patient eventually expired. However, the cause of death was not reported.

  Patient problems: Unspecified Infection

  MAUDE report 50894474 ↗
• MalfunctionMay 25, 2026Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PORT A CATH ALLEGEDLY DID NOT FUNCTION PROPERLY. HOWEVER, THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25269175 ↗
• InjuryMar 19, 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 IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24636071 ↗
• MalfunctionNov 20, 2025Deformation Due to Compressive Stress; Material Integrity Problem; Deformation Due to Compressive Stress; Material Integrity Problem

  A PATIENT UNDERWENT PORT PLACEMENT PROCEDURE USING MRI POWER PORT. IT WAS REPORTED THAT UPON OPENING A PORT KIT, THEY OBSERVED THAT THE PEEL-APART SHEATH WAS DENTED/BENT, WHILE ALL OTHER COMPONENTS IN THE KIT APPEARED INTACT. NO ADDITIONAL ISSUES WERE NOTED AT THE TIME OF INSPECTION. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23602144 ↗
• InjuryNov 6, 2025Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHEMOTHERAPY BY USING POWERPORT MRI ISP. PRIOR TO THE INJECTION OF THE CONTRAST, IT WAS NOTED THROUGH THE FLUOROSCOPY, THE CATHETER OF THE PORT WAS BROKEN HALF AND MIGRATED INTO THE LEFT PULMONARY ARTERY AND THE BROKEN PART WAS RETRIEVED BY THE RADIOLOGIST. FURTHER PATIENT WENT THROUGH SERIOUS PAIN. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 23483501 ↗
• InjuryOct 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT DIAGNOSED WITH UNSPECIFIED INFECTION, THROMBOSIS AND FIBRIN SHEATH FORMATION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23366283 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION AND METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Drug Resistant Bacterial Infection; Unspecified Infection

  MAUDE report 22881737 ↗
• MalfunctionAug 14, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801907 ↗
• InjuryJan 17, 2025Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE CATHETER FRACTURED, MATERIAL SEPARATED, MALPOSITIONED AND MIGRATED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 21177016 ↗
• InjuryJun 12, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT ONE MONTH AND THREE DAYS POST A PORT PLACEMENT IN THE LEFT SUBCLAVIAN VEIN, THE MID CATHETER WAS ALLEGEDLY FOUND TO BE FRACTURED UNDER COMPUTED TOMOGRAPHY AND X-RAY EXAMINATION. IT WAS FURTHER REPORTED THAT THE BROKEN CATHETER HAD ALLEGEDLY MIGRATED INTO THE PATIENT'S HEART. REPORTEDLY, THE PORT WAS SURGICAL REMOVED WHILE THE BROKEN CATHETER PIECE WAS REMOVED UNDER FLUORO AND WAS TO BE REPLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 19518297 ↗
• MalfunctionJun 14, 2023Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE PORT ALLEGEDLY BROKE APART. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17124674 ↗
• MalfunctionJun 1, 2023Loss of or Failure to Bond; Fluid/Blood Leak; Fracture; Material Separation; Obstruction of Flow; Failure to Advance; Deformation Due to Compressive Stress; Loss of or Failure to Bond; Fluid/Blood Leak; Fracture; Material Separation; Obstruction of Flow; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, WHEN TRIED TO REMOVE THE INNER SHEATH PART OF THE LUER-LOCK PIECE THAT IS ATTACHED TO THE OUTER GREY SHEATH ALLEGEDLY BROKE OFF AND BLOOD ALLEGEDLY STARTED TO SHOOT OUT. IT WAS FURTHER REPORTED THAT THE GUIDE WIRE WAS ALLEGEDLY DID NOT ENTER THROUGH THE OUTER SHEATH AND IT ALLEGEDLY OCCLUDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039749 ↗
• MalfunctionDec 1, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE PLASTIC PART OF THE TUNNELER BROKE INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT THE BROKEN SEGMENT WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908095 ↗
• MalfunctionApr 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF REPORTED INFORMATION INDICATES THAT MODEL 1809661, IMPLANTABLE PORT, ALLEGEDLY EXPERIENCED A FLUID LEAK. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A FEMALE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9963164 ↗