PowerPort ClearVUE 1678301Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741110825), received between May 14, 2024 and Jan 29, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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-1766-2018 · 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-1765-2018 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT, SOMETIME AFTER THE PORT PLACEMENT, THE PATIENT DEVELOPED AN UNSPECIFIED INFECTION. HOWEVER, THE PATIENT¿S CURRENT STATUS REMAINS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24208711 ↗
• InjurySep 30, 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: Thrombosis/Thrombus

  MAUDE report 23177727 ↗
• InjuryMay 2, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ON (B)(6) 2024, A 49 YEARS OLD FEMALE PATIENT UNDERWENT A PORT IMPLANTATION PROCEDURE USING A LOW ARTIFACT POWER PORT. SOMETIME POST A PORT PLACEMENT PROCEDURE, THERE WAS A 1.5 CM FRACTURE LINEAR IN ORIENTATION TO THE LONG AXIS OF THE CATHETER THAT WAS ALLEGEDLY NOTED, AND THE PORT ALLEGEDLY WAS LEAKING AT THE AREA OF THE SUBCLAVIAN VEIN INSERTION JUST UNDERNEATH THE CLAVICLE AND IMPLANTED PORT-A-CATH WAS REMOVED SURGICALLY AFTER RADIOGRAPHIC EVIDENCE. THE PORT WAS REMOVED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 21949180 ↗
• InjuryMay 14, 2024Fluid/Blood Leak; Difficult to Flush; Fracture; Suction Problem; Fluid/Blood Leak; Difficult to Flush; Fracture; Suction Problem

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THE PORT WAS ALLEGEDLY DIFFICULT TO BE FLUSHED. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY HAD DIFFICULTY WITH BLOOD RETURN AND WAS ALLEGEDLY FOUND TO BE FRACTURED AT THE LEFT INFRACLAVICULAR REGION. IT WAS ALSO REPORTED THAT THE CONTRAST ALLEGEDLY LEAKED IN THE LEFT INFRACLAVICULAR SPACE. REPORTEDLY, THE PORT WAS REMOVED AND HAD TO BE REPLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 19307615 ↗