Performer G09172Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002091726), received between Mar 14, 2018 and Mar 14, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 16, 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.

• MalfunctionMar 14, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING FEMORAL ACCESS THROUGH THE LEG FOR A LONG PULMONARY VALVE REPLACEMENT, THE PERFORMER MULLINS GUIDING SHEATH HEMOSTATIC VALVE END CAME OFF WHILE THE SHEATH WAS INSIDE OF THE PATIENT'S ANATOMY. THE PATIENT EXPERIENCED APPROXIMATELY 50 MILLILITERS (ML) OF BLOOD LOSS; NO INTERVENTION WAS REQUIRED AS A RESULT. NO DEVICES WERE BEING UTILIZED THROUGH THE SHEATH AT THE TIME OF THE INCIDENT. ANOTHER SHEATH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7338791 ↗