PowerPort M.R.I., ChronoFlex 1808000Recalls & reported problems

Summary

The FDA's MAUDE database contains 513 adverse event reports that list this exact device (DI 00801741000430), received between Aug 26, 2016 and Sep 29, 2026 — classified as 19 deaths, 374 injuries, 120 malfunctions.

The most frequently reported specific device problem is “Fracture” (63 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 513 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Fracture; Material Separation; Obstruction of Flow; Malposition of Device; Blocked Connection; Material Deformation; Migration

  It was reported through the litigation process that, sometime after the port placement, the catheter allegedly occluded. Additionally, a catheter kink or hairpin turn deformity caused port dysfunction and difficulty accessing the port. The catheter was reported to have been positioned deep and nearly central in the chest with a sharp turn near the subclavian stick site. It was further reported that the port body was positioned excessively deep (almost to the chest wall) with a skewed orientation, resulting in difficulty with access and port dysfunction. Additionally, a catheter fragment allegedly migrated to an unknown location. The patient reportedly experienced pain radiating to the neck and left upper quadrant (LUQ). However, the current status of the patient was unknown.

  Patient problems: Pain

  MAUDE report 50929888 ↗
• InjurySep 29, 2026Device Appears to Trigger Rejection; Obstruction of Flow

  It was reported through the litigation process that, sometime after the port placement, the catheter, port body, and reservoir allegedly occluded. Additionally, port catheter dysfunction with clotting or occlusion resulted in a nonfunctioning port, and port dysfunction was reported. It was further reported that the patient was diagnosed with thrombosis. The port was subsequently removed. However, the current status of the patient was unknown.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50928167 ↗
• InjurySep 24, 2026Device Appears to Trigger Rejection

  It was reported through the litigation process that, sometime after the port placement, 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 50880550 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported through the litigation process that, sometime after the port placement, the device allegedly malfunctioned. Additionally, the patient was diagnosed with an unspecified infection. However, the current status of the patient remains unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50867887 ↗
• MalfunctionSep 23, 2026Migration

  It was reported through the litigation process that, sometime after the port placement, the port allegedly malfunctioned, and the catheter was displaced and dislodged. However, there was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864546 ↗
• DeathSep 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 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 50864169 ↗
• InjurySep 1, 2026Device Appears to Trigger Rejection

  It was reported through the litigation process that, sometime after the port placement procedure, the patient was diagnosed with an unspecified infection and thrombosis. However, the current status of the patient remains unknown.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 50540225 ↗
• InjuryAug 27, 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 was unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50472960 ↗
• InjuryAug 18, 2026Expulsion

  It was reported through the litigation process that, sometime after the port placement, the port allegedly malfunctioned and became exposed. Additionally, the patient experienced pain at the port site. However, the current status of the patient is unknown.

  Patient problems: Pain; Skin Erosion

  MAUDE report 50298932 ↗
• InjuryAug 18, 2026Expulsion

  It was reported through the litigation process that, sometime after the port placement, the port allegedly malfunctioned and became exposed. Additionally, the patient experienced pain at the port site. However, the current status of the patient is unknown.

  Patient problems: Pain; Skin Erosion

  MAUDE report 50293436 ↗
• InjuryAug 18, 2026Fracture; Device Appears to Trigger Rejection

  It was reported through the litigation process that, sometime after the port placement, the catheter allegedly fractured. Additionally, the patient was diagnosed with an unspecified infection and thrombosis. However, the current status of the patient is unknown.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 50292960 ↗
• MalfunctionAug 18, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50292948 ↗
• InjuryAug 17, 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 sepsis. However, the current status of the patient was unknown.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 50270398 ↗
• InjuryAug 17, 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 sepsis. However, the current status of the patient was unknown.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 50270310 ↗
• InjuryAug 17, 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 was unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50270104 ↗
• InjuryAug 14, 2026Device Appears to Trigger Rejection; Migration

  It was reported through the litigation process that, sometime after the port placement, the device allegedly migrated. Additionally, the patient was diagnosed with an unspecified infection and thrombosis. However, the current status of the patient remains unknown.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 50251986 ↗
• InjuryAug 14, 2026Device Appears to Trigger Rejection; Migration

  It was reported through the litigation process that, sometime after the port placement, the device allegedly migrated. Additionally, the patient was diagnosed with an unspecified infection and thrombosis. However, the current status of the patient remains unknown.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 50251857 ↗
• InjuryAug 14, 2026Device Appears to Trigger Rejection

  It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with thrombosis and superior vena cava (SVC) syndrome. However, the current status of the patient remains unknown.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50248457 ↗
• InjuryAug 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 sepsis. However, the current status of the patient was unknown.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 50232997 ↗
• InjuryAug 13, 2026Fracture; Device Appears to Trigger Rejection; Obstruction of Flow

  It was reported through the litigation process that, sometime after the port placement, the catheter allegedly fractured. Additionally, the patient was diagnosed with thrombosis and occlusion. However, the current status of the patient was unknown.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 50232939 ↗
• DeathAug 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. It was further reported that the patient eventually expired. However, the cause of death was not reported.

  Patient problems: Unspecified Infection

  MAUDE report 50232801 ↗
• InjuryAug 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. However, the current status of the patient was unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50232575 ↗
• InjuryAug 11, 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 was unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50206371 ↗
• InjuryAug 10, 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 was unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50190211 ↗
• InjuryJul 10, 2026Device Appears to Trigger Rejection

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT PROCEDURE, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS, PULMONARY EMBOLISM, SUPERIOR VENA CAVA SYNDROME, PULMONARY EMBOLISM INDUCED SYSTEMIC INFLAMMATORY RESPONSE SYNDROME, AND SYSTOLIC HEART FAILURE. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Heart Failure/Congestive Heart Failure; Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 25777049 ↗