PowerPort ClearVUE 1618001Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741026492), received between Oct 18, 2019 and Sep 1, 2026 — classified as 2 deaths, 8 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Device Appears to Trigger Rejection; Migration

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

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50539172 ↗
• MalfunctionJul 29, 2026Fluid/Blood Leak; Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50065508 ↗
• DeathJun 1, 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. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 25353009 ↗
• InjuryMar 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 IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24725380 ↗
• InjuryMar 30, 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 24725215 ↗
• MalfunctionFeb 25, 2026Fracture

  A PATIENT WAS PREPPED FOR A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE SLIM PORT. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE BASE IS CRACKED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24440147 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pulmonary Embolism

  MAUDE report 24330378 ↗
• InjuryJan 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 IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24197609 ↗
• DeathDec 25, 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. IT WAS FURTHER REPORTED THAT THE PATIENT EVENTUALLY EXPIRED. HOWEVER, THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 23891822 ↗
• MalfunctionOct 27, 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 23390547 ↗
• MalfunctionAug 28, 2025Packaging Problem; Packaging Problem

  ON (B)(6) 2025, A PATIENT PREPPED FOR A PORT PLACEMENT PROCEDURE USING CHRONOFLEX SINGLE-LUMEN POWER PORT. PRIOR TO THE PROCEDURE IT WAS NOTED THAT THE PACKAGE RECEIVED WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910911 ↗
• MalfunctionAug 28, 2025Packaging Problem; Packaging Problem

  ON (B)(6) 2025, A PATIENT PREPPED FOR A PORT PLACEMENT PROCEDURE USING CHRONOFLEX SINGLE-LUMEN POWER PORT. PRIOR TO THE PROCEDURE IT WAS NOTED THAT THE PACKAGE RECEIVED WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910907 ↗
• InjuryAug 4, 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 22697279 ↗
• InjuryJun 5, 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 THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22148528 ↗
• MalfunctionMay 28, 2025Difficult to Remove; Suction Problem; Difficult to Remove; Suction Problem

  A PATIENT UNDERWENT THE PORT PLACEMENT PROCEDURE USING LOW ARTIFACT POWER PORT. DURING THE PREPARATION OF PORT PLACEMENT PROCEDURE, THE DEVICE BASE COULD NOT BE RETRACTED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094156 ↗
• MalfunctionAug 19, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOMETIMES POST PORT PLACEMENT PROCEDURE, THE NEEDLE WAS ALLEGEDLY WENT THROUGH THE BACK SIDE OF THE PORT CAUSING LEAKING OF FLUID FROM INFUSION. THE PORT WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15256560 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT AN IMPLANTABLE PORT WAS IMPLANTED SUCCESSFULLY. THE DEVICE WAS REMOVED. THE PATIENT WAS DIAGNOSED WITH LINE SEPSIS AND INITIAL ENCOUNTER OF CELLULITIS OF CHEST WALL; HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Cellulitis; Sepsis

  MAUDE report 12099651 ↗
• MalfunctionApr 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 1618001 IMPLANTABLE PORT ALLEGEDLY HAD INSUFFICIENT INFORMATION. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE A PATIENT WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9962607 ↗
• MalfunctionOct 18, 2019Suction Problem; Suction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL 1618001 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED A SUCTION PROBLEM AND WAS UNABLE TO ASPIRATE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9209884 ↗