HEMO-CATH® MC101042PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884908093278), received between Sep 18, 2018 and Mar 30, 2023 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2023Break; Break

  UPON THE PATIENT HAVING AN ECHO, IT WAS NOTICED THAT THE TIP OF THE CATHETER LINE HAD BROKEN OFF AND HAD BECOME LODGED IN HIS RIGHT PULMONARY ARTERY. CARDIAC SURGEONS HAVE RECOMMENDED WE LEAVE IT IN SITU AS OPERATING TO REMOVE IT IS MORE DANGEROUS THAN LEAVING IT IN.

  Patient problems: Foreign Body In Patient

  MAUDE report 16644360 ↗
• MalfunctionMar 10, 2023Leak/Splash; Leak/Splash

  DURING CLEANING PROCEDURE TWO (2) HOLES WERE MADE IN THE CATHETER LUMEN. THE CATHETER WAS CHANGED ACCORDINGLY. DEVICE WAS DISCARDED AND NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16521387 ↗
• MalfunctionSep 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON ASPIRATION, THE LINE CLOSES COMPLETELY, AND ON INSTALLATION, THERE IS A SIGNIFICANT BULGE TO ARTERIAL LUMEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7885691 ↗