PowerPort ClearVUE 1676301Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741110788), received between May 18, 2021 and Apr 23, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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-1763-2018 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 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 24964788 ↗
• MalfunctionMar 16, 2026Component Missing; Packaging Problem

  IT WAS REPORTED THAT THE CUSTOMER DID NOT RECEIVE THE PRODUCT POWERPORT CLEARVUE SLIM IMPLANTABLE PORT IN THE PACKAGE. THEY RECEIVED THE PACK SLIP, BUT THE ITEM ITSELF WAS MISSING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603354 ↗
• MalfunctionJul 25, 2024Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE GUIDEWIRE ALLEGEDLY GOT CAUGHT INSIDE THE RIGHT ATRIUM AND ALLEGEDLY WOULD NOT BE RELEASED EASILY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824805 ↗
• MalfunctionJul 25, 2024Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE GUIDEWIRE ALLEGEDLY GOT CAUGHT INSIDE THE RIGHT ATRIUM AND ALLEGEDLY WOULD NOT BE RELEASED EASILY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824574 ↗
• InjuryMay 18, 2021Adverse 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 BLEEDING, PAIN AND ITCHING. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Itching Sensation; Pain

  MAUDE report 11840476 ↗