Hemo-Cath® SL15Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884908045222), received between Sep 9, 2021 and Sep 9, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2021Break; Break

  DURING INSERTION, AFTER BLOOD WAS ASPIRATED USING THE NEEDLE PROVIDED, THE WIRE WAS FED THROUGH. INITIALLY FED EASILY AND THEN MET RESISTANCE. THE ULTRASOUND SHOWED THE WIRE HAD GONE INTO THE INTERNAL JUGULAR AND THROUGH THE POSTERIOR WALL. THE NEEDLE WAS REMOVED AND THEN THE WIRE WAS PULLED BACK, MAJORITY PULLED BACK EASILY BUT THEN MET RESISTANCE. ULTRASOUND SHOWED THE WIRE WAS STUCK TO THE POSTERIOR WALL OF INTERNAL JUGULAR. ON CLOSER INSPECTION OF WIRE THE INNER COIL PART HAD SEPARATED FROM OUTER FIRM PART, AND SUBSEQUENTLY THE COIL WAS STUCK IN THE VEIN MAKING IT IMPOSSIBLE TO REMOVE WITH GENTLE TRACTION. VASCULAR SURGERY CONTACTED AND PATIENT REQUIRED SURGICAL CUT DOWN TO REMOVE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12445699 ↗