SlimPort, ChronoFlex 0655510Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741026317), received between Aug 6, 2019 and Sep 25, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Infuse” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2023Fluid/Blood Leak; Fracture; Suction Problem; Fluid/Blood Leak; Fracture; Suction Problem

  IT WAS REPORTED THAT ONE YEAR, THREE MONTHS, AND EIGHTEEN DAYS POST PORT PLACEMENT, WHILE ACCESSING THE PORT, FLUID WAS ALLEGEDLY FOUND UNDER THE SKIN IN THE AREA DIRECTLY SURROUNDING THE PORT AND WAS FOUND THAT THERE WAS LEAKAGE OF SALINE ALLEGEDLY COMING FROM THE CATHETER TRACT WHEN THE PORT WAS FLUSHED. IT WAS FURTHER REPORTED THAT A FRACTURE WAS ALLEGEDLY FOUND UNDER THE PROXIMAL CATHETER. FURTHERMORE, BLOOD RETURN WAS NOT ALLEGEDLY OBTAINED AT THE TIME OF ACCESS. REPORTEDLY, THE PORT WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17805895 ↗
• InjuryAug 6, 2019Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS POST PORT PLACEMENT VIA LEFT INTERNAL JUGULAR VEIN IN THE RIGHT CHEST THE CATHETER WAS ALLEGEDLY OCCLUDED. REPORTEDLY, DURING THE PORT REMOVAL PROCEDURE IT WAS IDENTIFIED THE CATHETER ALLEGEDLY ADHERED TO THE TISSUE FROM THE LEFT INNOMINATE VEIN TO THE SUPERIOR VENA CAVA . THE PORT HUB WAS ABLE TO BE REMOVED, BUT THE CATHETER REMOVAL WAS UNSUCCESSFUL. IT WAS FURTHER REPORTED, APPROXIMATELY ONE YEAR POST PORT HUB REMOVAL THE CATHETER ERODED THROUGH THE SKIN AND A THORACOTOMY WAS PERFORMED TO REMOVE THE CATHETER. THE PATIENT REMAINS IN THE HOSPITAL RECOVERING FROM THE SURGICAL PROCEDURE.

  Patient problems: Injury; Occlusion

  MAUDE report 8865415 ↗