PowerPort ClearVUE 1618070Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00801741026508), received between Jun 1, 2020 and Sep 28, 2026 — classified as 1 death, 25 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported through the litigation process that, sometime after the port placement, the port allegedly malfunctioned. It was further reported that contrast extravasation occurred at the port body site with swelling in the surrounding subcutaneous tissue, resulting in a nonfunctional port. Additionally, the patient was diagnosed with bacteremia (bloodstream infection). The port was subsequently removed. However, the current status of the patient was unknown.

  Patient problems: Bacteremia; Extravasation; Swelling/ Edema

  MAUDE report 50913803 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacteremia; Extravasation; Swelling/ Edema

  MAUDE report 50913799 ↗
• MalfunctionSep 25, 2026Unsealed Device Packaging

  On (b)(6) 2026, a patient was prepped for a port placement procedure using the PowerPort ClearVUE Slim. During the preparation for use, the outer package cover was reportedly adhered to the inner cover containing the port, resulting in both covers opening simultaneously when the package was opened. Since the inside of the package was stuck to the outside of the package, when they opened it up, it all flew everywhere which caused it to fall on the ground and compromise its sterility. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894168 ↗
• InjuryJul 6, 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 25713247 ↗
• MalfunctionJun 8, 2026Deformation Due to Compressive Stress; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT PROCEDURE, THE PORT CATHETER HAD ALLEGEDLY KINKED AND RETRACTED. HOWEVER, THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25423268 ↗
• MalfunctionApr 2, 2026Fracture; Deformation Due to Compressive Stress

  A PATIENT WAS PREPPED FOR A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE SLIM. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE DEVICE WAS RECEIVED WITH A BENT TIP. FURTHER FRACTURE WAS DISCOVERED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764285 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24543697 ↗
• DeathFeb 13, 2026Device Appears to Trigger Rejection; Obstruction of Flow

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT, SOMETIME AFTER PORT PLACEMENT, THE PORT CATHETER HAD OBSTRUCTION TO FLOW, AND THE PATIENT WAS DIAGNOSED WITH THROMBOSIS AND OCCLUSION. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 24331422 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24001384 ↗
• InjuryDec 10, 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 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 23767375 ↗
• InjuryDec 2, 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 THROMBOSIS AND PULMONARY EMBOLISM. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 23692046 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT POST PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH INFECTION AND HEMORRHAGING OR INTERNAL BLEEDING. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 23578132 ↗
• InjuryNov 17, 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 23566784 ↗
• MalfunctionOct 24, 2025Fracture; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE SLIM IMPLANTABLE PORT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE WHITE PIECE WAS ALLEGEDLY FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380742 ↗
• MalfunctionSep 3, 2025Fracture; Fracture

  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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22950464 ↗
• InjuryAug 25, 2025Migration; Migration

  IT WAS REPORTED THAT POST PORT PLACEMENT, THE PORT WAS ALLEGEDLY MOVED DOWN ON CHEST FROM THE PLACE IT WAS ORIGINALLY PLACED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 22881869 ↗
• InjuryAug 12, 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 UNSPECIFIED INFECTION AND DIAGNOSED WITH DVT PROPHYLAXIS, AND PULMONARY EMBOLISM. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 22780335 ↗
• MalfunctionJul 31, 2025Migration; Migration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673965 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY TWO YEARS EIGHT MONTHS AND SIXTEEN DAYS POST PORT PLACEMENT PROCEDURE THROUGH THE RIGHT INTERNAL JUGULAR VEIN APPROACH, THE PATIENT DEVELOPED WITH CHEST PAIN, PALPITATIONS AND ARRHYTHMIA. REPORTEDLY, THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 22606632 ↗
• InjuryJun 20, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY ONE WEEK AND TWO DAYS POST A PORT PLACEMENT FOR VASCULAR ACCESS FOR CHEMOTHERAPY TREATMENT, THE NURSES ARE UNABLE TO DE-ACCESS THE PORT, IT WAS FURTHER REPORTED THAT PATIENT DEVELOPED PAIN AROUND THE PORT SITE. REPORTEDLY, THE PORT WAS REMOVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pain

  MAUDE report 22294736 ↗
• InjuryJun 19, 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 PLACEMENT, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22291830 ↗
• MalfunctionApr 28, 2025Disconnection; Fracture; Material Separation; Suction Problem; Disconnection; Fracture; Material Separation; Suction Problem

  IT WAS REPORTED THAT POST PORT PLACEMENT PROCEDURE THE PORT ALLEGEDLY SEPARATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917559 ↗
• InjuryApr 1, 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 DEVELOPED WITH UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacteremia; Bacterial Infection; Embolism/Embolus; Purulent Discharge; Sepsis; Unspecified Infection

  MAUDE report 21737676 ↗
• MalfunctionMar 3, 2025Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING THE PREPARATION OF A PORT PLACEMENT PROCEDURE, THE PORT STEM WAS ALLEGEDLY KINKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509767 ↗
• InjuryNov 13, 2024Adverse 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 PROCEDURE, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20671146 ↗