Soft-Cell PC-2 Dialysis Catheter Kit 12.5 F x 23 cm 5534230Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741012457), received between Mar 16, 2016 and Aug 3, 2022 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2022Fracture; Fracture

  IT WAS REPORTED THAT FEW MONTHS POST CATHETER PLACEMENT, A PART OF THE CLAMP WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15154773 ↗
• MalfunctionNov 12, 2019Suction Problem; Suction Problem

  IT WAS REPORTED THAT SOME TIME POST DIALYSIS CATHETER PLACEMENT, THE BLUE LUER CONNECTOR OF THE DIALYSIS CATHETER ALLEGEDLY ASPIRATED AIR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9312705 ↗
• DeathMar 16, 2016Insufficient Device Problem Information

  ON (B)(6) 2016 - IT WAS REPORTED PER MEDICON THAT ON (B)(6) 2016 THE DEVICE WAS PLACED INTO THE PATIENT AND X-RAY REVEALED NO ABNORMALITIES. ON (B)(6) 2016 DIALYSIS BEGAN AND IT WAS SAID THE PATIENT TOOK A SUDDEN TURN FOR THE WORSE. THE PATIENT EXPIRED. DETAILS ARE CURRENTLY UNDER INVESTIGATION.

  Patient problems: Death

  MAUDE report 5504109 ↗