PowerPort ClearVUE 5676300Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741110771), received between Apr 19, 2019 and Aug 11, 2026 — classified as 1 death, 7 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (3 reports).

2 FDA recall records name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 15, 2020Class IIOpen, Classified

   The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.

   Z-1964-2020 · Root cause: Employee error · Recall details · FDA record ↗

2. Feb 8, 2018Class IICompleted

   The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

   Z-1768-2018 · Root cause: Error in labeling · Recall details · FDA record ↗

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.

• MalfunctionAug 11, 2026Difficult to Flush; Obstruction of Flow

  On July 22, 2026, a patient underwent a port placement procedure using the PowerPort ClearVUE Slim. Post the procedure, the catheter was allegedly clogged and could not be flushed. The procedure was completed using another device. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50205612 ↗
• InjuryMar 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 IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24679349 ↗
• MalfunctionFeb 3, 2026Fracture

  ON (B)(6) 2026, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE SLIM. DURING THE PREPARATION IT WAS NOTED THAT THE CATHETER WAS FRAYED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24243860 ↗
• InjuryJan 20, 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 THROMBOSIS, AND EXPERIENCED PAIN AND DISCOMFORT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Discomfort; Pain; Thrombosis/Thrombus

  MAUDE report 24114157 ↗
• InjuryOct 29, 2025Expulsion; Expulsion

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT ABOUT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PORT ERODED, AND THE PATIENT WAS ALLEGEDLY DEVELOPED WITH SKIN EROSION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Skin Erosion

  MAUDE report 23411099 ↗
• InjurySep 12, 2025Difficult to Flush; Improper or Incorrect Procedure or Method; Difficult to Flush; Improper or Incorrect Procedure or Method

  ON (B)(6) 2025, A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE SLIM IMPLANTABLE PORT. IT WAS REPORTED THAT POST THE PROCEDURE, THE PORT WAS ALLEGEDLY NOT FLUSHED. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED A VEIN STICKING OUT OF HER CHEST ABOVE THE PORT DEVICE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 23035690 ↗
• InjuryMay 19, 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 DEVELOPED WITH UNSPECIFIED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22041592 ↗
• InjuryFeb 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 ALLEGEDLY DEVELOPED INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21442138 ↗
• MalfunctionApr 14, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE GUIDEWIRE WAS ALLEGEDLY FOUND TO BE LOADED IN THE DEVICE BACKWARDS. THE PROCEDURE WAS COMPLETED USING ANOTHER GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102985 ↗
• MalfunctionAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED REDNESS AND ITCHINESS IN THE CHEST. REPORTEDLY, THERE IS NO ADDITIONAL INTERVENTION PERFORMED OR MEDICATION PRESCRIBED TO TREAT REDNESS AND ITCHINESS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17448117 ↗
• MalfunctionMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT, THE PATIENT EXPERIENCED DISCOMFORT AROUND PORT. IT WAS FURTHER REPORTED THAT NO ADDITIONAL INTERVENTION OR MEDICATION REQUIRED. THE PATIENT WAS SENT TO THE HOSPITAL AND THE PORT WAS FLUSHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14446177 ↗
• MalfunctionApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST PORT PLACEMENT PROCEDURE, THE PATIENT REPORTEDLY HAD STINGING ISSUE AFTER THE REMOVAL OF PORT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13974906 ↗
• DeathOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO DAYS POST PORT PLACEMENT, THE PATIENT ALLEGEDLY DECEASED.

  Patient problems: Insufficient Information

  MAUDE report 12705033 ↗
• InjuryMar 11, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS POST PORT IMPLANT, THE PORT INSERTION SITE ALLEGEDLY TURNED GREEN AND WOUND OPENED UP WITH PUS AROUND THE SITE. THEREFORE, PATIENT WAS HOSPITALIZED AND HEALTHCARE PROVIDER ALLEGEDLY IDENTIFIED INFECTION. REPORTEDLY, TREATMENT FOR THE INFECTION WAS PROVIDED AND THE DEVICE WAS REMOVED. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 9821003 ↗
• MalfunctionJan 15, 2020Nonstandard Device; Fitting Problem; Component Misassembled; Nonstandard Device; Fitting Problem; Component Misassembled

  IT WAS REPORTED THAT THE PORT CATHETER LOCK WAS ALLEGEDLY TOO LARGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591793 ↗
• MalfunctionJan 15, 2020Nonstandard Device; Fitting Problem; Component Misassembled; Nonstandard Device; Fitting Problem; Component Misassembled

  IT WAS REPORTED THAT THE PORT CATHETER LOCK WAS ALLEGEDLY TOO LARGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591787 ↗
• MalfunctionOct 18, 2019Component Incompatible; Component Missing; Component Incompatible; Component Missing

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 5676300 PORT AND CATHETER ALLEGEDLY EXPERIENCED INCOMPATIBLE COMPONENT AND MISSING COMPONENTS. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9211268 ↗
• MalfunctionOct 18, 2019Component Missing; Component Missing

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 5676300 PORT AND CATHETER ALLEGEDLY EXPERIENCED A MISSING COMPONENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9211267 ↗
• MalfunctionApr 19, 2019Component Missing; Component Missing

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 5676300 PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR THE INCORRECT SIZE WAS ALLEGEDLY IDENTIFIED. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. OF THE ONE EVENT, DID NOT INVOLVE PATIENT. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8533002 ↗