Hemo-Cath® SL12PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884908045123), received between Jun 21, 2017 and Nov 7, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 7, 2021Leak/Splash; Leak/Splash

  A PORE APPEARED IN THE CATHETER EXTENSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760498 ↗
• MalfunctionAug 24, 2021Leak/Splash; Leak/Splash

  LEAKAGE FROM THE EXTENSION TUBE WAS DISCOVERED WHILE FLUSHING THE CATHETER PRIOR TO HEMODIALYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12358886 ↗
• MalfunctionJun 21, 2017Leak/Splash; Crack; Leak/Splash

  UPON INSPECTION AFTER CATHETER REMOVAL A ~0.5CM CRACK ON CENTRAL PART OF TUBING, BEFORE THE HUB THAT BIFURCATES ON THE POSTERIOR SIDE, FLUSH WITH PT. SKIN WAS NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6657847 ↗