PowerPort M.R.I., Groshong 1878000Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00801741027246), received between Jul 12, 2018 and Jul 10, 2026 — classified as 2 deaths, 24 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (21 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 37 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT PROCEDURE, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25777051 ↗
• InjuryMar 30, 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 24724968 ↗
• InjuryFeb 26, 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 PULMONARY EMBOLUS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pulmonary Embolism

  MAUDE report 24451302 ↗
• InjuryDec 23, 2025Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING POWERPORT MRI. POST A PORT PLACEMENT PROCEDURE, IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY DETACHED FROM PORT AND LODGED INTO RIGHT ATRIUM. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 23875215 ↗
• MalfunctionNov 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT POST PORT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY MALFUNCTIONED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657350 ↗
• InjurySep 18, 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 AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 23081581 ↗
• MalfunctionJul 30, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663351 ↗
• InjuryJul 11, 2025Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  A PATIENT UNDERWENT FOR PORT PLACEMENT PROCEDURE USING POWERPORT MRI 8GS, INT. W SP, ATT S/L. IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE PORT WAS ALLEGEDLY FOUND FRACTURED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A CARDIAC CATH TO REMOVE THE FRACTURED PIECE FROM THE ATRIUM AND VENTRICLE OF THE HEART. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 22476961 ↗
• InjuryJul 11, 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. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22476611 ↗
• InjuryMay 22, 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 22067567 ↗
• InjuryMay 6, 2025Fracture; Fracture

  ON (B)(6) 2016, PATIENT UNDERWENT A PROCEDURE USING THE BARD MRI POWERPORT IMPLANTABLE PORT FOR UNKNOWN MEDICAL CONDITION. SOMETIME POST PORT PLACEMENT PROCEDURE, THE PORT CATHETER FRACTURED AND PATIENT DEVELOPED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21965948 ↗
• InjuryMay 6, 2025Fracture; Fracture

  ON (B)(6) 2016, PATIENT UNDERWENT A PROCEDURE USING THE BARD MRI POWERPORT IMPLANTABLE PORT FOR UNKNOWN MEDICAL CONDITION. SOMETIME POST PORT PLACEMENT PROCEDURE, THE PORT CATHETER FRACTURED AND PATIENT DEVELOPED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21965946 ↗
• InjuryMay 6, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PORT ALLEGEDLY DEVELOPED WITH CATHETER FRACTURE AND PATIENT DEVELOPED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21965944 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME AFTER PORT PLACEMENT PROCEDURE, PATIENT WAS DIAGNOSED WITH THROMBOSIS AND PULMONARY EMBOLISM. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 21924454 ↗
• InjuryJan 10, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME LATER POST A PORT PLACEMENT PROCEDURE, THE PORT CATHETER WAS 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 21123122 ↗
• InjuryDec 5, 2024Entrapment of Device; Fracture; Material Separation; Migration; Entrapment of Device; Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER POST PORT PLACEMENT PROCEDURE, THE PORT ALLEGEDLY DEVELOPED WITH CATHETER FRACTURE. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 20850643 ↗
• MalfunctionOct 28, 2024Fracture; Material Separation; Migration; Fracture

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

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

  MAUDE report 20542678 ↗
• InjurySep 30, 2024Fluid/Blood Leak; Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn; Fluid/Blood Leak; Fracture; Material Separation; Deformation Due to Compressive Stress; Naturally Worn

  IT WAS REPORTED THAT SEVEN MONTHS AND FOUR DAYS POST A PORT PLACEMENT, THE PORT CATHETER WAS ALLEGEDLY BROKEN IN PATIENT. IT WAS FURTHER REPORTED THAT A FLUID LEAK WAS ALSO ALLEGEDLY OBSERVED. FURTHERMORE, AFTER THE INSTALLATION OF CONTRAST, CONTRAST WAS IDENTIFIED AT THE TIP OF THE CATHETER; HOWEVER, AT THE INTERSECTION OF THE FIRST RIB AND THE CLAVICLE, A FRACTURE WAS ALLEGEDLY IDENTIFIED WITH CONTRAST EXTRAVASATION TRACKING RETROGRADE ALONG THE CATHETER INTO THE PORT RESERVOIR UNDER X-RAY EXAMINATION. MOREOVER, THE PATIENT ALLEGEDLY EXPERIENCED SHOULDER PAIN. REPORTEDLY, A SURGERY WAS PERFORMED TO REMOVE THE PORT CATHETER. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Extravasation; Pain

  MAUDE report 20331370 ↗
• InjuryJul 15, 2024Fluid/Blood Leak; Fracture; Material Separation; Migration; Fluid/Blood Leak; Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY ONE MONTH AND THIRTEEN DAYS LATER POST PORT PLACEMENT FOR THE CHEMOTHERAPY TREATMENT, THE PORT CATHETER ALLEGEDLY HAD FRACTURE, FLUID LEAK AND THE FRACTURED CATHETER MIGRATED INTO THE MAIN PULMONARY ARTERY. REPORTEDLY, THE FRACTURED CATHETER AND THE PORT WAS REMOVED AND NEW PORT HAS BEEN IMPLANTED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 19747046 ↗
• DeathJul 8, 2024Fracture; Fracture

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

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

  MAUDE report 19698081 ↗
• DeathJul 8, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

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

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

  MAUDE report 19689031 ↗
• InjuryApr 11, 2024Difficult to Flush; Fracture; Material Separation; Suction Problem; Migration; Difficult to Flush; Fracture; Material Separation; Suction Problem; Migration

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, THE PORT WAS ALLEGEDLY NOT WORKING. IT WAS FURTHER REPORTED THAT WHEN REMOVING THE PORT AND THE CATHETER, THE CATHETER WAS NOT INTACT AS A WHOLE AND THE DISTAL END OF THE CATHETER WAS ALLEGEDLY FOUND TO BE BROKEN OFF. FURTHERMORE, THE BROKEN PIECE OF THE CATHETER HAD TRAVELED THROUGH THE RIGHT ATRIUM ACROSS THE TRICUPSID VALVE THROUGH THE RIGHT VENTRICLE AND ALLEGEDLY GOT LODGED AT THE PULMONARY ARTERY. REPORTEDLY, THE PATIENT HAD TO GO TO THE CATHETERIZATION LABORATORY FOR REMOVAL OF THE DISTAL END OF THE CATHETER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 19085932 ↗
• InjuryMar 5, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

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

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

  MAUDE report 18835620 ↗
• InjuryJan 24, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY SOMETIME POST A PORT PLACEMENT, THE CATHETER ALLEGEDLY FRACTURED AND MIGRATED TO THE HEART. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 18569513 ↗
• MalfunctionDec 13, 2023Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY BROKE OFF. REPORTEDLY, THE PORT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18317291 ↗