Soft-Cell PC Dialysis Catheter Kit 12.5 F x 23 cm 5533230Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741012402), received between Mar 30, 2017 and Jul 22, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE DEVICE ALLEGEDLY LEAKED AT THE CONNECTION PART OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12208160 ↗
• InjuryMar 30, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A FEVER AND WAS DIAGNOSED AS INFECTION. THE CATHETER WAS REMOVED, BUT THE CUFF REMAINED IN THE PATIENT'S BODY. THE PATIENT RECOVERED FROM THE INFECTION AS OF (B)(6) 2017. ANOTHER CATHETER WAS IMPLANTED VIA THE LEFT SUBCLAVIAN VEIN. ON 3/21/2017 - THE CATHETER WAS IN PLACE FOR APPROXIMATELY 3 YEARS AND 8 MONTHS. ADDITIONAL INFORMATION REGARDING THE REPORTED INFECTION WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 6446360 ↗