Performer G09582Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002095823), received between May 12, 2016 and Mar 22, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2023Sharp Edges; Sharp Edges

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591005 ↗
• MalfunctionApr 11, 2022Break; Break

  AS REPORTED, THE TIP OF A PERFORMER INTRODUCER SHEATH WAS FOUND BROKEN WITHIN THE PACKAGING. THE PACKAGING WAS STILL INTACT. THE DEVICE WAS NOT USED DURING A PROCEDURE AND DID NOT IMPACT ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14075339 ↗
• MalfunctionNov 15, 2021Break; Break

  AS REPORTED, THE TIP OF A PERFORMER INTRODUCER WAS SEPARATED INSIDE THE PACKAGING. THE DEVICE WAS NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12813254 ↗
• MalfunctionJan 28, 2021Material Separation; Material Separation

  AS REPORTED, THE TIP OF A PERFORMER INTRODUCER'S DILATOR WAS FOUND TO BE SEPARATED UPON FLUSHING THE DEVICE, PRIOR TO PATIENT CONTACT. THE DEVICE HAD BEEN STORED HANGING IN A CABINET. NO DAMAGE TO THE DEVICE PACKAGE WAS NOTED. THE DEVICE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11245676 ↗
• MalfunctionMay 12, 2016Leak/Splash; Leak/Splash

  DURING AN UNKNOWN PROCEDURE ON THE MALE PATIENT IT WAS NOTED THAT THERE WAS BLOOD LEAKAGE FROM THE FITTING OF THE CHECK-FLO VALVE. THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5649716 ↗