PowerPort ClearVUE 5678300Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741110818), received between Feb 15, 2021 and Aug 26, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 reports).

2 FDA recall records 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-1770-2018 · Root cause: Error in labeling · 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-1771-2018 · 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.

• InjuryAug 26, 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 was unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50447964 ↗
• InjuryAug 21, 2026Device Appears to Trigger Rejection

  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 50364261 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026, a patient underwent a port placement procedure using a PowerPort ClearVue Slim. Post the procedure on (b)(6) 2026, the patient observed a rash near the neck incision and beneath the port body incision in the areas where dressing tape had been applied. The patient reported that the rash was not associated with itching, redness, drainage, or swelling. The patient applied hydrocortisone cream and believed the reaction was caused by the dressing tape. There was no reported patient injury.

  Patient problems: Rash

  MAUDE report 50097615 ↗
• InjuryApr 17, 2026Fracture; Material Separation; Migration

  ON (B)(6) 2026, THE PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE POWERPORT CLEARVUE SLIM. DURING THE PROCEDURE, THE DISTAL END OF THE CATHETER BROKE OFF AND BECAME LODGED IN THE PATIENTS VENA CAVA. AS A RESULT, THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM IN THE MAIN HOSPITAL, WHERE THE SEPARATED CATHETER SEGMENT WAS SUCCESSFULLY REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 24907488 ↗
• 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 24209633 ↗
• InjuryDec 24, 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 WAS DIAGNOSED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23886378 ↗
• InjuryOct 28, 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 WAS DIAGNOSED WITH THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23402980 ↗
• MalfunctionSep 30, 2025Material Puncture/Hole; Deformation Due to Compressive Stress; Material Puncture/Hole; Deformation Due to Compressive Stress

  ON (B)(6) 2025, A PATIENT WAS PREPARED FOR A PORT PLACEMENT PROCEDURE USING CLEARVUE POWERPORT, PRIOR TO THE PROCEDURE, DURING THE PREPARATION, IT WAS REPORTED THAT THE SHEATH WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE DISTAL TIP WAS FOUND TO HAVE A KINK OR A HOLE IN THE DILATOR. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23177952 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIMES POST A PORT PLACEMENT, THE PATIENT ALLEGEDLY HAD SOME BUMPS ON HIS FEET AND LEGS. IT WAS FURTHER REPORTED THAT THE BUMPS WERE NOTED LAST NIGHT BUT DOES NOT HAVE BUMPS ANYWHERE ELSE ON HIS BODY. ADDITIONALLY, HE DESCRIBES THEM AS "ITCHY". CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Itching Sensation; Swelling/ Edema

  MAUDE report 21580482 ↗
• InjurySep 20, 2024Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME POST PORT PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Chest Pain; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20270199 ↗
• InjuryOct 12, 2023Expulsion; Expulsion

  IT WAS REPORTED THAT APPROXIMATELY TEN MONTHS POST A PORT PLACEMENT, THE PORT ALLEGEDLY ERODED THROUGH THE SKIN. REPORTEDLY, THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Skin Erosion

  MAUDE report 17918514 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST PORT IMPLANT, THE PATIENT ALLEGEDLY EXPERIENCED YEAST INFECTION WHICH WAS TRACED BACK TO THE IMPLANTED PORT DEVICE. THE DEVICE WAS REMOVED OFF THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Fungal Infection

  MAUDE report 11326639 ↗