HemoSplit XK Long-Term Hemodialysis Catheter 5683730Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741012730), received between Aug 31, 2016 and Aug 26, 2019 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Kinked” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE COVERING THAT GOES OVER THE TUNNELER AND THE CATHETER PRIOR TO TUNNELING WAS ALLEGEDLY SPLIT PRIOR TO USE. REPORTEDLY, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8930905 ↗
• MalfunctionJul 30, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHEN THE DIALYSIS CATHETER CLAMPS WERE CLOSED, THIS HAD CAUSED AN ALLEGED KINK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7731593 ↗
• MalfunctionJul 27, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHEN THE DIALYSIS CATHETER CLAMPS WERE CLOSED, THIS HAD CAUSED AN ALLEGED KINK. IT WAS FURTHER ALLEGED THAT THE DECISION WAS MADE TO NOT CLAMP THE LINE AS IT WAS CLOSE TO THE ARTERIAL BRANCH. APPROXIMATELY SEVEN DAYS LATER, THE DEFECT WAS NO LONGER VISUALLY DETECTABLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7727810 ↗
• MalfunctionMay 25, 2018Kinked; Kinked

  IT WAS REPORTED THAT CLOSING THE CLAMP OF A DIALYSIS CATHETER ALLEGEDLY CAUSED A KINK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7546705 ↗
• MalfunctionMay 25, 2018Kinked; Kinked

  IT WAS REPORTED THAT CLOSING THE CLAMP OF A DIALYSIS CATHETER ALLEGEDLY CAUSED A KINK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7546703 ↗
• MalfunctionMay 25, 2018Kinked; Kinked

  IT WAS REPORTED THAT CLOSING THE CLAMP OF A DIALYSIS CATHETER ALLEGEDLY CAUSED A KINK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7546699 ↗
• MalfunctionMay 25, 2018Kinked; Kinked

  IT WAS REPORTED THAT CLOSING THE CLAMP OF A DIALYSIS CATHETER ALLEGEDLY CAUSED A KINK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7546659 ↗
• MalfunctionMay 25, 2018Kinked; Kinked

  IT WAS REPORTED THAT CLOSING THE CLAMP OF A DIALYSIS CATHETER ALLEGEDLY CAUSED A KINK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7546574 ↗
• MalfunctionMay 25, 2018Kinked; Kinked

  IT WAS REPORTED THAT CLOSING THE CLAMP OF A DIALYSIS CATHETER ALLEGEDLY CAUSED A KINK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7546467 ↗
• MalfunctionMay 25, 2018Kinked; Kinked

  IT WAS REPORTED THAT CLOSING THE CLAMP OF A DIALYSIS CATHETER ALLEGEDLY CAUSED A KINK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7546401 ↗
• MalfunctionMay 25, 2018Kinked; Kinked

  IT WAS REPORTED THAT CLOSING THE CLAMP OF A DIALYSIS CATHETER ALLEGEDLY CAUSED A KINK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7546398 ↗
• MalfunctionMay 25, 2018Kinked; Kinked

  IT WAS REPORTED THAT CLOSING THE CLAMP OF A DIALYSIS CATHETER ALLEGEDLY CAUSED A KINK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7546396 ↗
• MalfunctionMay 25, 2018Kinked; Kinked

  IT WAS REPORTED THAT CLOSING THE CLAMP OF A DIALYSIS CATHETER ALLEGEDLY CAUSED A KINK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7546393 ↗
• MalfunctionAug 2, 2017Break

  IT WAS REPORTED BY THE FACILITY THAT THEY HAD A BREAK IN THE CENTRAL LINE OF A DIALYSIS CATHETER. THEY STATED THE RED CLAMP BROKE AND WAS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6761096 ↗
• MalfunctionAug 31, 2016Failure to Advance

  IT WAS REPORTED BY THE FACILITY THAT THE NURSE WAS UNABLE TO ADVANCE THE GUIDEWIRE. ANOTHER KIT WAS OPENED AND USED SUCCESSFULLY, NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5919150 ↗