PowerPort ClearVUE 1608062Recalls & reported problems

Summary

The FDA's MAUDE database contains 571 adverse event reports that list this exact device (DI 00801741026430), received between May 4, 2017 and Sep 30, 2026 — classified as 18 deaths, 362 injuries, 191 malfunctions.

The most frequently reported specific device problem is “Fracture” (95 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 571 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Suction Problem; Obstruction of Flow; Blocked Connection

  It was reported through the litigation process that, sometime after the port placement, the port allegedly malfunctioned, including failure to access, poor blood return, and inability to draw blood from or flush the port. Additionally, the device allegedly occluded and occlusion treatment was required. However, no patient injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947213 ↗
• InjurySep 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 was unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50945158 ↗
• MalfunctionSep 29, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929318 ↗
• MalfunctionSep 29, 2026Obstruction of Flow

  It was reported through the litigation process that, sometime after the port placement, the catheter and port body or reservoir allegedly became occluded. However, there was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927851 ↗
• InjurySep 28, 2026Device Appears to Trigger Rejection; Migration

  It was reported through the litigation process that, sometime after the port placement, the catheter tip allegedly migrated. Additionally, the patient was diagnosed with thrombosis and pulmonary embolism. However, the current status of the patient is unknown.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 50911166 ↗
• InjurySep 25, 2026Device Appears to Trigger Rejection

  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 was unknown.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50896369 ↗
• MalfunctionSep 24, 2026Fracture; Deformation Due to Compressive Stress

  A patient underwent a port placement procedure using the PowerPort ClearVUE ISP. During use, the puncture needle tip was bent, and the junction of the needle tip was broken. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881317 ↗
• InjurySep 24, 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 50880547 ↗
• 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, thrombosis and sepsis. However, the current status of the patient was unknown.

  Patient problems: Sepsis; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 50880025 ↗
• InjurySep 23, 2026Device Appears to Trigger Rejection

  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 was unknown.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50868151 ↗
• MalfunctionSep 8, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674217 ↗
• InjurySep 3, 2026Device Appears to Trigger Rejection; Obstruction of Flow

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

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 50587842 ↗
• DeathAug 26, 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. It was further reported that the patient eventually expired. However, the cause of death was not reported.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 50454725 ↗
• DeathAug 26, 2026Device Appears to Trigger Rejection

  It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with thrombosis. It was further reported that the patient eventually expired. However, the cause of death was not reported.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50454706 ↗
• DeathAug 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 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 50451501 ↗
• DeathAug 20, 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. It was further reported that the patient eventually expired. However, the cause of death was not reported.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 50345830 ↗
• InjuryAug 19, 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 50316672 ↗
• InjuryAug 18, 2026Device Appears to Trigger Rejection

  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 was unknown.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50298558 ↗
• MalfunctionAug 18, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50298262 ↗
• DeathAug 18, 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 50295966 ↗
• InjuryAug 17, 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 50270102 ↗
• InjuryAug 14, 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 embolism. However, the current status of the patient was unknown.

  Patient problems: Pulmonary Embolism

  MAUDE report 50249885 ↗
• 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 septic pulmonary embolism. However, the current status of the patient is unknown.

  Patient problems: Pulmonary Embolism; Sepsis; Unspecified Infection

  MAUDE report 50232649 ↗
• InjuryAug 12, 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 sepsis. However, the current status of the patient was unknown.

  Patient problems: Sepsis; Thrombosis/Thrombus

  MAUDE report 50219281 ↗
• InjuryAug 5, 2026Fracture; Material Separation; Migration

  It was reported through the litigation process that, sometime after the port placement, the catheter had allegedly fractured, and the fractured fragment migrated to the right atrium and right ventricle. However, the current status of the patient was unknown.

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

  MAUDE report 50137945 ↗