Hemo-Cath® SL28Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884908045864), received between Aug 5, 2019 and Apr 12, 2022 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2022Break; Break

  EXIT SUTURE DUE FOR REMOVAL FROM MEDCOMP CENTRAL LINE. SUTURE WRAPPED TIGHTLY AROUND LINE, USED A SUTURE REMOVAL KIT. AFTER SUTURE REMOVAL PATIENT BECAME ANXIOUS, SHORT OF BREATH, WITH CHEST DISCOMFORT. DR. CAME AND ASSESSED PLACED IMMEDIATELY ON OXYGEN AND PLACED ON HER RIGHT SIDE. WE WERE ABLE TO DETERMINE THAT THERE WAS AIR IN LUMEN OF CENTRAL LINE, LATER FOUND A SMALL HOLE IN LINE NEAR EXIT SITE. LINE PROMPTLY REMOVED BY MD. PT KEPT FOR 2 HOURS POST LINE REMOVAL AND WAS DISCHARGED FROM CLINIC STABLE. PLACED ON OXYGEN AND PLACED ON RIGHT SIDE CENTRAL LINE IMMEDIATELY REMOVED. ONCE LINE REMOVED SYMPTOMS RESOLVED.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 14084335 ↗
• MalfunctionAug 5, 2019Disconnection; Disconnection

  THE ARTERIAL AND VENOUS LUERS AT THE END OF THE EXTENSION LINES BECAME LOOSE, WITH THE VENOUS LUER COMPLETELY DISCONNECTING FROM THE EXTENSION LINE. ALCOHOL PREP PADS ARE USED TO CLEANSE THE LINES, USING A TOTAL OF ABOUT 8-10 PREP PADS DURING THE CONNECTION AND DISCONNECTION PROCESS. MORE PADS ARE USED IF THE PATIENT'S LINE HAS TO BE REVERSED AT ANY POINT DURING TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8859297 ↗