Soft-Cell PC Dialysis Catheter Kit 12.5 F x 19 cm 5533190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741012396), received between Jul 7, 2017 and Apr 14, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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

• MalfunctionApr 14, 2020Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  WAS REPORTED THAT SOME TIME POST DIALYSIS CATHETER PLACEMENT, EXTERNAL LEAK WAS ALLEGEDLY FOUND DUE TO SUSPECTED CATHETER TIP DAMAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9959670 ↗
• MalfunctionFeb 18, 2020Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY NINE MONTHS POST DIALYSIS CATHETER PLACEMENT, THE CLAMP WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9721244 ↗
• MalfunctionJul 25, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT THERE WAS AN ALLEGED TEAR IN THE TUNNELER PRIOR TO PATIENT USE. HOWEVER, THE HEALTHCARE PROFESSIONAL USED THE DEVICE AND ALLEGEDLY THE SIZE OF THE TEAR INCREASED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7720314 ↗
• MalfunctionMay 23, 2018Material Frayed; Material Frayed

  IT WAS REPORTED THAT AFTER INSERTING THE GUIDEWIRE THROUGH THE NEEDLE, THE DISTAL TIP OF THE GUIDEWIRE WAS ALLEGEDLY ENTANGLED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7539339 ↗
• MalfunctionJul 7, 2017Material Frayed; Difficult to Remove

  IT WAS REPORTED THAT THE INTRODUCER NEEDLE COULD NOT BE PULLED OUT FOR REMOVING AFTER THE INSERTION OF GUIDE WIRE FOLLOWING THE ACCESSING TO THE VEIN BY THE PUNCTURE NEEDLE. ON 6/15/2017 - RETURNED WIRE IS FRAYED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6692568 ↗