PowerPort ClearVUE 5676301Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741110795), received between May 23, 2019 and Aug 17, 2026 — classified as 1 death, 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Flush” (2 reports).

1 FDA recall record name this device's identifier.

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. Feb 8, 2018Class IICompleted

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

   Z-1769-2018 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268886 ↗
• InjuryApr 13, 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. HOWEVER, THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24861566 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE THROUGH 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 24686793 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24684886 ↗
• DeathJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING 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 24197508 ↗
• MalfunctionJun 10, 2022Difficult to Flush; Suction Problem; Difficult to Flush; Suction Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY ONE-MONTH NINETEEN DAYS POST INDEX PROCEDURE USING A POWERPORT CATHETER AT RIGHT SIDE OF CHEST, THE PORT CATHETER WAS ALLEGEDLY FAILED TO ASPIRATE BLOOD, DIFFICULT TO FLUSH AND WAS SUCCESSFULLY TREATED WITH LOW ARTIFACT POWER PORT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14651796 ↗
• InjuryJun 9, 2022Migration; Migration

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY FOUR DAYS POST INDEX PROCEDURE USING A LOW ARTIFACT POWER PORT AT RIGHT SIDE OF CHEST, THE TIP OF THE PORT CATHETER WAS ALLEGEDLY MIGRATED INTO RIGHT SUBCLAVIAN AND WAS NOT SUCCESSFULLY TREATED. THE CURRENT STATUS OF THE PATIENT IS NOT PROVIDED.

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

  MAUDE report 14641024 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY ONE MONTH POST PORT CATHETER PLACEMENT PROCEDURE THROUGH THE INTERNAL JUGULAR VEIN APPROACH ON THE RIGHT CHEST, THE PATIENT HAD AN ADVERSE EVENT OF PORT INFECTION. IT WAS FURTHER REPORTED THAT THE THE DEVICE WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 14641021 ↗
• MalfunctionJun 3, 2022Difficult to Flush; Suction Problem; Malposition of Device; Difficult to Flush; Suction Problem; Malposition of Device

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY THREE DAYS POST PORT CATHETER PLACEMENT PROCEDURE, THE PATIENT HAD AN ADVERSE EVENT OF CATHETER ALLEGEDLY FAILED TO INFUSE AND FAILED TO ASPIRATE BLOOD. IT WAS FURTHER REPORTED THAT THE TIP OF THE CATHETER WAS ALLEGEDLY MALPOSITIONED. REPORTEDLY, THE DEVICE WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14586676 ↗
• MalfunctionJun 1, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS EIGHT DAYS POST PORT PLACEMENT VIA INTERNAL JUGULAR VEIN APPROACH ON THE LEFT CHEST, THE PATIENT HAD AN ADVERSE EVENT OF PAIN AT THE PORT SITE DUE TO NEEDLE BENT. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS REPLACED AND THE PAIN WAS RECOVERED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14562712 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST PORT PLACEMENT, THE TISSUE SURROUNDING PORT IS INFECTED AND REMOVED. THE PATIENT STATUS WAS UNKNOWN.

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

  MAUDE report 10754377 ↗
• InjuryMay 23, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ONE DAY POST PORT PLACEMENT, THERE WAS ALLEGEDLY REDNESS AT THE PORT SITE. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER PRESCRIBED MEDICATIONS (BENADRYL, STEROID AND ANTIBIOTIC) FOR THE ALLEGED SYMPTOM; HOWEVER, THERE WAS NO DEVICE DEFICIENCY. THE PATIENT REPORTS TO BE IN STABLE CONDITION.

  Patient problems: Erythema

  MAUDE report 8638779 ↗