PowerPort M.R.I., ChronoFlex 1808002Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00801741026997), received between Jul 23, 2019 and Sep 29, 2026 — classified as 20 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Deformation Due to Compressive Stress

  It was reported through the litigation process that, sometime after the port placement, catheter kinking was noted in the subclavian region. However, there was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929891 ↗
• InjuryAug 18, 2026Difficult to Flush; Fracture; Device Appears to Trigger Rejection

  It was reported through the litigation process that, sometime after the port placement, the catheter allegedly fractured without migration. Additionally, the port could neither be flushed nor aspirated. It was further reported that the patient was diagnosed with fibrin sheath formation. However, the current status of the patient is unknown.

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

  MAUDE report 50296275 ↗
• InjuryApr 20, 2026Malposition of Device; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER ALLEGEDLY MIGRATED AND WAS MALPOSITIONED. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24921812 ↗
• InjuryMar 25, 2026Obstruction of Flow

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

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 24685103 ↗
• InjuryFeb 27, 2026Fracture

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME AFTER THE PORT PLACEMENT, A SMALL KNICK WAS IDENTIFIED IN THE CATHETER. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION AND THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 24466144 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24066894 ↗
• InjuryNov 10, 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 23508807 ↗
• InjuryAug 14, 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 ALLEGEDLY DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22801622 ↗
• InjuryAug 4, 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 ALLEGEDLY DEVELOPED WITH THROMBOSIS AND WAS DIAGNOSED WITH AFIBRILLATION OF HEART, ALSO THE PORT HAD MALFUNCTIONED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Atrial Fibrillation; Thrombosis/Thrombus

  MAUDE report 22698891 ↗
• InjuryJul 24, 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 ALLEGEDLY DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22589276 ↗
• MalfunctionJul 24, 2025Migration; Migration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584957 ↗
• InjuryJul 15, 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 22510943 ↗
• InjuryJul 11, 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 22477653 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIMES POST A PORT PLACEMENT, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22334224 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22085942 ↗
• 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, THE PATIENT WAS DIAGNOSED WITH INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21924645 ↗
• 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, MALPOSITIONED AND MIGRATED. IT WAS FURTHER REPORTED THAT PATIENT ALLEGEDLY DEVELOPED WITH THROMBOSIS. 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 21177588 ↗
• MalfunctionNov 4, 2024Disconnection; Disconnection

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20596640 ↗
• InjuryAug 26, 2024Fluid/Blood Leak; Fracture; Obstruction of Flow; Fluid/Blood Leak; Fracture; Obstruction of Flow

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT ONE YEAR, THREE MONTHS AND THREE DAYS POST A PORT PLACEMENT, THE PORT CATHETER ALLEGEDLY DEVELOPED FRACTURE AND EXTRAVASATION. IT WAS FURTHER REPORTED THAT CATHETER OCCLUDED AND PATIENT DEVELOPED WITH INFECTION, THROMBOSIS, EROSION AND PAIN. REPORTEDLY, THE PORT WAS REMOVED AND NEW PORT HAS BEEN IMPLANTED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Extravasation; Pain; Skin Erosion; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 20062931 ↗
• InjuryAug 26, 2024Fracture; Fracture

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY TWO MONTHS AND FOURTEEN DAYS POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH NECK PAIN AND THROMBOSIS. IT WAS FURTHER REPORTED THAT PATIENT WAS DEVELOPED WITH BACTEREMIA, BACTERIAL INFECTION AND SEPSIS. REPORTEDLY, THE PORT WAS REMOVED AND NEW PORT HAS BEEN IMPLANTED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacteremia; Bacterial Infection; Neck Pain; Sepsis; Thrombosis/Thrombus

  MAUDE report 20062888 ↗
• MalfunctionMay 14, 2024Difficult to Flush; Fracture; Suction Problem; Difficult to Flush; Fracture; Suction Problem

  IT WAS REPORTED THAT TWENTY EIGHT DAYS POST A PORT PLACEMENT, THE PORT WAS ALLEGEDLY NOT WORKING. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY FOUND TO BE FRACTURED UPON PORTOGRAM. REPORTEDLY, THE PORT WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19307695 ↗
• InjuryMay 1, 2024Fluid/Blood Leak; Fracture; Suction Problem; Fluid/Blood Leak; Fracture; Suction Problem

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER SECTION WAS ALLEGEDLY FOUND TORN LONGITUDINALLY ABOUT ONE-FOURTH INCH IN LENGTH UPON REMOVAL. IT WAS FURTHER REPORTED THAT THE BLOOD WAS ALLEGEDLY DIFFICULT TO BE ASPIRATED. FURTHERMORE, THE PORT ALLEGEDLY LEAKED AND IT WAS FOUND THAT THE PATIENT REPORTEDLY EXPERIENCED EXTRAVASATION OF FLUID LEAK UNDER COMPUTED TOMOGRAPHY EXAMINATION. REPORTEDLY, THE DEFECTIVE PORT WAS REMOVED AND REPLACED WITH A NEW PORT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 19227021 ↗
• InjuryMar 22, 2024Suction Problem; Suction Problem

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, THE DEVICE ALLEGEDLY HAD BLOOD ASPIRATION DIFFICULTIES. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY HAD A BUMP OVER THE PORT ACCESS SITE AND PEROXIDE WAS APPLIED OVER THE AREA. REPORTEDLY, THE PATIENT EXPERIENCED PAIN AFTER PUTTING THE PEROXIDE OVER THE AREA. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 18958526 ↗
• MalfunctionDec 24, 2021Difficult to Flush; Suction Problem; Difficult to Flush; Suction Problem

  IT WAS REPORTED THAT SOMETIMES POST PORT PLACEMENT PROCEDURE, THE PORT ALLEGEDLY HAD ISSUES IN ASPIRATING BLOOD AND INFUSING MEDICATIONS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13083345 ↗
• InjuryApr 15, 2021Obstruction of Flow; Material Deformation; Material Twisted/Bent; Migration; Obstruction of Flow; Material Deformation; Material Twisted/Bent; Migration

  IT WAS REPORTED THAT SOME POST PORT PLACEMENT, THE DEVICE MIGRATED FROM CAROTID ARTERY TO DOWN INTO THE CHEST. REPORTEDLY PATIENT EXPERIENCED PAIN. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED AND REPLACED. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Pain

  MAUDE report 11669854 ↗