PowerPort ClearVUE 5616000Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00801741027376), received between May 25, 2018 and Sep 29, 2026 — classified as 1 death, 36 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 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 50 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Material Deformation

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

  Patient problems: Unspecified Infection

  MAUDE report 50929316 ↗
• DeathSep 1, 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 50545787 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  A patient underwent port placement procedure using the PowerPort ClearVUE Slim. Post the procedure on (b)(6) 2026, during infusion the patient allegedly experienced bruised, swollen and tightness around the port site. The current status of the patient is unknown.

  Patient problems: Bruise/Contusion; Swelling/ Edema

  MAUDE report 50208842 ↗
• InjuryApr 21, 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 REMAINS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24935010 ↗
• InjuryMar 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 THROMBOSIS. FURTHER, FIBRIN SHEATH FORMATION WAS OBSERVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24629478 ↗
• InjuryFeb 24, 2026Fracture; Device Appears to Trigger Rejection

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DEVELOPED 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 24424918 ↗
• InjuryFeb 20, 2026Fracture; Device Appears to Trigger Rejection

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME AFTER THE PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED, AND FIBRIN SHEATH FORMATION WAS OBSERVED. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 24398719 ↗
• InjuryJan 30, 2026Failure to Advance; Deformation Due to Compressive Stress

  ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE SLIM. DURING THE PROCEDURE, RINGS WERE OBSERVED ON THE AIRGUARD INTRODUCER THAT INTERFERED WITH INSERTION AND PREVENTED THE DEVICE FROM BEING USED AS INTENDED. AS A RESULT, THE PORT COULD NOT BE IMPLANTED. AND ALSO, PATIENT EXPERIENCED BLEEDING. THE CURRENT STATUS OF PATIENT IS FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219574 ↗
• InjuryJan 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 IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24209122 ↗
• InjuryDec 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 DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23825507 ↗
• InjuryDec 16, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PORT CATHETER FRACTURED. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23813753 ↗
• InjuryDec 9, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PORT CATHETER FRACTURED. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23755147 ↗
• InjuryNov 27, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT, THE PORT CATHETER FRACTURED. IT WAS FURTHER REPORTED THAT EXTRAVASATION WAS OBSERVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 23663594 ↗
• InjuryOct 23, 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 23365521 ↗
• InjuryOct 23, 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 23365397 ↗
• InjuryOct 8, 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 23242438 ↗
• MalfunctionAug 20, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING POWERPORT CLEARVUE SLIM IMPLANTABLE PORT. DURING THE PLACEMENT PROCEDURE, IT WAS REPORTED THAT THE PORT CATHETER WAS ALLEGEDLY FOUND KINKED AT THE HUB. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849497 ↗
• InjuryAug 8, 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 DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22748157 ↗
• InjuryJul 25, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY FRACTURED. THE PATIENT DEVELOPED WITH NUMBNESS AND PAIN IN HANDS AND FEET. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Numbness; Pain

  MAUDE report 22607273 ↗
• InjuryJul 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 DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacterial Infection; Erythema; Purulent Discharge; Unspecified Infection

  MAUDE report 22492551 ↗
• InjuryJun 23, 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 DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22305343 ↗
• InjuryJun 20, 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 22296950 ↗
• InjuryJun 20, 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 ALLEGEDLY DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22295106 ↗
• InjuryJun 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 POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY DEVELOPED WITH UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22182322 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT FOR A PORT PLACEMENT PROCEDURE USING POWERPORT CLEARVUE SLIM IMPLANTABLE PORT. AFTER THE PROCEDURE, SOMETIME THE PATIENT ALLEGEDLY HAD "BURNING SENSATION" DURING THE INFUSION. FURTHER IT WAS REPORTED THAT IT WAS SWOLLEN IN THE AREA OF THE PORT DELIVERING THE INFUSION. ADDITIONALLY, TYLENOL AND COLD PACK WAS PROVIDED TO THE PATIENT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Burning Sensation; Swelling/ Edema

  MAUDE report 22000948 ↗