PowerPort ClearVUE 5608062Recalls & reported problems

Summary

The FDA's MAUDE database contains 542 adverse event reports that list this exact device (DI 00801741027369), received between Sep 14, 2016 and Sep 30, 2026 — classified as 31 deaths, 389 injuries, 122 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (39 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 542 reports, in the reporter's own words as published by the FDA.

• 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 50945162 ↗
• InjurySep 29, 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 50929876 ↗
• InjurySep 28, 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 50912189 ↗
• InjurySep 28, 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 50911168 ↗
• InjurySep 28, 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 50910842 ↗
• InjurySep 25, 2026Device Appears to Trigger Rejection; Material Twisted/Bent; Migration

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

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50898248 ↗
• MalfunctionSep 24, 2026Fracture; Suction Problem

  On (b)(6), 2022, a patient underwent a port placement procedure using the PowerPort ClearVUE isp. On (b)(6), 2026, the port was removed following completion of treatment and due to a loss of blood return. During the removal procedure, the catheter segment located in the subclavian vein was found to be fractured. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881887 ↗
• MalfunctionSep 23, 2026Insufficient Device Problem Information

  It was reported through the litigation process that, sometime after port placement, the port allegedly malfunctioned or experienced a mechanical failure. However, no patient injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868153 ↗
• 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 50868133 ↗
• InjurySep 23, 2026Expulsion

  It was reported through the litigation process that, sometime after the port placement, the patient was diagnosed with an unspecified infection, erosion and wound complications at port body site. However, the current status of the patient was unknown.

  Patient problems: Skin Erosion; Unspecified Infection

  MAUDE report 50868125 ↗
• InjurySep 1, 2026Fracture; Obstruction of Flow

  It was reported through the litigation process that, sometime after the port placement procedure, the catheter had allegedly fractured. It was additionally reported that the patient was diagnosed with occlusion. However, the current status of the patient remains unknown.

  Patient problems: Obstruction/Occlusion

  MAUDE report 50543386 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50540235 ↗
• InjuryAug 27, 2026Device Appears to Trigger Rejection; Migration

  It was reported through the litigation process that, sometime after the port placement, the device migrated and the patient was diagnosed with fibrin sheath. However, the current status of the patient was unknown.

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

  MAUDE report 50472962 ↗
• InjuryAug 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. However, the current status of the patient was unknown.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50446972 ↗
• 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 50296572 ↗
• InjuryAug 17, 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, thrombosis, pulmonary embolism. Additionally, the patient was diagnosed with sepsis secondary to infection. However, the current status of the patient remains unknown.

  Patient problems: Pulmonary Embolism; Sepsis; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 50271909 ↗
• 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 an unspecified infection, thrombosis, pulmonary embolism and sepsis. However, the current status of the patient was unknown.

  Patient problems: Pulmonary Embolism; Sepsis; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 50249387 ↗
• InjuryAug 12, 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 50220186 ↗
• InjuryAug 12, 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, holes in chest and allergic reaction. However, the current status of the patient was unknown.

  Patient problems: Cardiac Perforation; Hypersensitivity/Allergic reaction; Unspecified Infection

  MAUDE report 50218517 ↗
• InjuryAug 5, 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 submucosal edema. However, the current status of the patient was unknown.

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 50137949 ↗
• InjuryAug 5, 2026Fluid/Blood Leak; Fracture

  It was reported through the litigation process that, sometime after the port placement, the catheter allegedly fractured and fluid leaked into chest cavity. However, the current status of the patient is unknown.

  Patient problems: Extravasation

  MAUDE report 50137939 ↗
• InjuryAug 5, 2026Fluid/Blood Leak; Fracture

  It was reported through the litigation process that, sometime after the port placement, the catheter allegedly fractured and fluid leaked into chest cavity. However, the current status of the patient is unknown.

  Patient problems: Extravasation

  MAUDE report 50137936 ↗
• InjuryAug 5, 2026Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  Approximately eight years ago, a patient underwent a port placement procedure using a Power Port Clear VUE ISP. On (b)(6) 2026, following treatment administration through the port, the patient removed the dressing and observed blood on it. It was further reported that there was yellowish green discoloration of the skin, consistent with a healing bruise, along with pain at the site. The current patient condition is unknown.

  Patient problems: Bruise/Contusion; Pain; Skin Discoloration

  MAUDE report 50137670 ↗
• InjuryJul 27, 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 50032833 ↗
• InjuryJul 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 50021964 ↗