RetrO Long-Term Hemodialysis Catheter RS27SH32Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741014079), received between Mar 29, 2017 and Nov 9, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Bent” (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.

• MalfunctionNov 9, 2017Bent; Kinked

  IT WAS REPORTED BY MS&S THAT THE FACILITY STATED THAT THEY ATTEMPTED TO PLACE A RETRO HEMODIALYSIS CATHETER IN A PATIENT AND THE LARGE INTRODUCER KINKED AND WAS NOT ABLE TO BE UTILIZED FOR THE CATHETER PLACEMENT. THEY STATED THAT A SECOND KIT WAS OPENED FOR THE PROCEDURE AND ANOTHER INTRODUCER WAS USED AND THE PLACEMENT OF THE RETRO HEMODIALYSIS CATHETER WAS COMPLETED. SHE ASKED MS&S FOR ANOTHER INTRODUCER TO HAVE ON HAND. MS&S INFORMED HER THAT THE AIRGUARD INTRODUCER 16.5 FR COULD BE UTILIZED AND INFORMED HER THAT THE AIRGUARD INTRODUCER IS VALVED. NO REPORTED PATIENT INJURY. (B)(6) 2017 IT WAS REPORTED BY THE FACILITY THAT THE GUIDEWIRE WITH THE J-HOOK IS WHAT SOMETIMES BECOMES BENT OR KINKED AND HAS TO BE REMOVED AND ANOTHER DEVICE USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7015248 ↗
• MalfunctionMar 29, 2017Device Packaging Compromised; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A HAIR IN THE SEALED PACKAGING. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6444230 ↗