PowerPort M.R.I. 1859660Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00801741027222), received between Oct 12, 2018 and Mar 23, 2026 — classified as 1 death, 15 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Component Missing” (19 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 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 24659432 ↗
• InjuryFeb 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 24439213 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT ISP M.R.I. POST PROCEDURE AFTER CHEMOTHERAPY INFUSION, THE PATIENT ALLEGEDLY EXPERIENCED PAIN. ON (B)(6) 2025, THE DEVICE WAS REMOVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pain

  MAUDE report 24267467 ↗
• InjuryJan 13, 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 AND EXPERIENCED CHEST PAIN. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Chest Pain; Unspecified Infection

  MAUDE report 24058131 ↗
• InjuryDec 23, 2025Fluid/Blood Leak; Material Puncture/Hole; Obstruction of Flow; Fluid/Blood Leak; Material Puncture/Hole; Obstruction of Flow

  A PATIENT UNDERWENT PORT PLACEMENT PROCEDURE USING THE MRI POWERPORT ISP ON (B)(6) 2024. IT WAS REPORTED THAT ON (B)(6) 2025 POST THE PORT PLACEMENT IN THE RIGHT CHEST WALL VIA INTERNAL JUGULAR VEIN, THE PORT WAS ALLEGEDLY FOUND LEAKING ON THE BACK PLATE. IT WAS FURTHER REPORTED THAT PATIENT ALLEGEDLY EXPERIENCED PAIN AND SKIN ULCERATION AND PAIN, SKIN ULCERATION OCCURRED BECAUSE EXTRAVASATION OF THE CHEMOTHERAPY. ON (B)(6) 2025, THE DEVICE WAS REMOVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Extravasation; Pain; Ulcer

  MAUDE report 23874980 ↗
• InjurySep 2, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PORT CATHETER FRACTURED. THE PATIENT ALSO DEVELOPED WITH UNSPECIFIED INFECTION AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22935653 ↗
• MalfunctionJul 24, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PORT WAS CLOTTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586506 ↗
• InjuryJul 16, 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 WAS ALLEGEDLY DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22520417 ↗
• InjuryJul 15, 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 THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22505655 ↗
• InjuryJun 19, 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 22292008 ↗
• InjuryMay 23, 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 WAS ALLEGEDLY DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22075984 ↗
• InjuryOct 1, 2024Migration; Migration

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

  Patient problems: Unspecified Infection

  MAUDE report 20341073 ↗
• DeathSep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY NINE MONTHS TWENTY-EIGHT DAYS LATER POST PORT PLACEMENT PROCEDURE FOR INTRAVENOUS ACCESS, THE PATIENT ALLEGEDLY DIAGNOSED WITH BACTEREMIA. IT WAS FURTHER REPORTED THAT PATIENT DEVELOPED SEPSIS AND SEPTIC SHOCK AND WAS TREATED WITH ANTIBIOTICS. HOWEVER, THE PATIENT WAS EXPIRED AND THE CAUSE OF DEATH WAS SEPTIC SHOCK AND METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS BACTEREMIA.

  Patient problems: Bacteremia; Sepsis; Septic Shock

  MAUDE report 20134001 ↗
• MalfunctionNov 21, 2023Adverse 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 PATIENT ALLEGEDLY EXPERIENCED PAIN IN PENIS. IT WAS FURTHER REPORTED THAT PAIN HAS BEEN SUBSIDED BUT THE PAIN STILL EXISTS. FURTHERMORE, THERE IS NO INFORMATION PROVIDED REGARDING THE MEDICAL INTERVENTION PERFORMED OR MEDICATION PRESCRIBED TO TREAT THE PAIN IN PENIS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18179596 ↗
• MalfunctionAug 14, 2023Loss of or Failure to Bond; Fracture; Difficult to Insert; Material Separation; Loss of or Failure to Bond; Fracture; Difficult to Insert; Material Separation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, ONE HALF OF THE PLASTIC RING OF THE SHEATH ALLEGEDLY BROKE OFF. IT WAS REPORTED THAT IT WAS ALLEGEDLY DIFFICULT TO INSERT INTO THE SHEATH AND VEIN. REPORTEDLY, THE CATHETER WAS ABLE TO GET INTO THE VEIN AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17539076 ↗
• MalfunctionMar 4, 2023Loss of or Failure to Bond; Fracture; Material Separation; Deformation Due to Compressive Stress; Difficult or Delayed Separation; Loss of or Failure to Bond; Fracture; Material Separation; Deformation Due to Compressive Stress; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, WHEN PEELING THE SHEATH AWAY, THE PLASTIC RING ALLEGEDLY BROKE IN TWO PIECES AND FELL OFF OF WHITE PLASTIC PART OF SHEATH MAKING IT DIFFICULT FOR RADIOLOGIST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483339 ↗
• InjuryFeb 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PORT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD A LEAK. IT WAS FURTHER REPORTED THAT THE DEVICE HAD TO BE REMOVED. REPORTEDLY, THE PATIENT EXPERIENCED PAIN AND VISION CHANGES. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT PATIENT STATUS WAS UNKNOWN.

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

  MAUDE report 16377493 ↗
• MalfunctionAug 2, 2022Fracture; Deformation Due to Compressive Stress; Difficult or Delayed Separation; Premature Separation; Fracture; Deformation Due to Compressive Stress; Difficult or Delayed Separation; Premature Separation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE PEEL AWAY SHEATH ALLEGEDLY HAD FALL APART WHILE INSERTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15144162 ↗
• MalfunctionAug 2, 2022Difficult or Delayed Separation; Premature Separation; Difficult or Delayed Separation; Premature Separation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE PEEL AWAY SHEATH ALLEGEDLY HAD FALL APART WHILE INSERTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15143458 ↗
• InjuryApr 13, 2022Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST PORT PLACEMENT VIA RIGHT SUBCLAVIAN, THE PIECE OF THE CATHETER WAS ALLEGEDLY HAD BROKEN FROM THE CATHETER. IT WAS FURTHER REPORTED THAT PORTION OF THE CATHETER WAS ALLEGEDLY STILL IN THE PATIENT HEART. REPORTEDLY, THE PATIENT WAS TRANSFERRED TO IR FOR REMOVAL OF THE BROKEN CATHETER. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED EMBOLISM. AFTER REMOVAL OF THE PORT, THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS STABLE.

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

  MAUDE report 14098824 ↗
• MalfunctionAug 15, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING PORT PLACEMENT PROCEDURE, THE MATERIAL WAS ALLEGEDLY FRAGMENTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12322328 ↗
• InjuryAug 11, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE ALLEGEDLY HAD A MATERIAL FRAGMENTATION. IT WAS FURTHER REPORTED THAT FRAGMENTED MATERIAL REMAINS IN THE PATIENT BODY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 12306001 ↗
• InjuryDec 1, 2020Break; Fracture; Material Separation; Separation Failure; Break; Fracture; Material Separation; Separation Failure

  IT WAS REPORTED THAT DURING PORT PLACEMENT, THE DEVICE ALLEGEDLY BROKE WHILE BEING REMOVED FROM THE PEEL APART SHEATH. IT WAS FURTHER REPORTED THAT AN AIR EMBOLISM OCCURRED IN THE PATIENT AND THE RADIOLOGIST STILL MANAGED TO GET THE CATHETER INTO THE PATIENT. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Air Embolism

  MAUDE report 10926106 ↗
• MalfunctionApr 8, 2020Fracture; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1859660 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED FRACTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941818 ↗
• MalfunctionApr 19, 2019Component Missing; Component Missing

  THIS REPORT SUMMARIZES SEVEN MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL 1859660 IMPLANTABLE PORT EXPERIENCED A COMPONENT MISSING. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL SEVEN REPORTED EVENTS DID NOT INVOLVE A PATIENT. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR ANY OF THE EVENTS.

  Patient problems: No Patient Involvement

  MAUDE report 8531614 ↗