Performer G13496Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002134966), received between Mar 9, 2016 and Apr 17, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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.

• MalfunctionApr 17, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A DIALYSIS ACCESS MANAGEMENT PROCEDURE ON AN UNSPECIFIED ARM, THE PERFORMER INTRODUCER VALVE WAS FOUND TO BE LEAKING AFTER THE BALLOON AND WIRE WERE REMOVED. A NEW INTRODUCER WAS INSERTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7437153 ↗
• MalfunctionAug 3, 2017Material Separation

  PRIOR TO PATIENT CONTACT, UPON INSERTING DILATOR INTO SHEATH THE INTRODUCER PORTION SEPARATED FROM THE HUB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6765577 ↗
• MalfunctionOct 27, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED DURING A FISTULAGRAM UPON INITIAL PLACEMENT OVER A WIRE WHEN THE WIRE AND DILATOR WERE REMOVED IT WAS NOTED THE VALVE WAS "EXCESSIVELY" LEAKING. THE DISTRICT MANAGER REPORTED: NO ADDITIONAL PROCEDURES REPORTED. NO ADVERSE EFFECTS REPORTED. NO DEVICE BREAKAGE OR SEPARATION REPORTED. NO OTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6060633 ↗
• MalfunctionMar 10, 2016Leak/Splash; Leak/Splash

  DURING A FISTULA GRAM PROCEDURE, THE VALVES ON THE DEVICE LEAKED. THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION AND THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THIS DEVICE. NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES OR INTERVENTION WAS REQUIRED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5492268 ↗
• MalfunctionMar 9, 2016Leak/Splash; Leak/Splash

  DURING A FISTULAGRAM PROCEDURE, THE VALVES ON THE DEVICE LEAKED. THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION AND THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THIS DEVICE. NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES OR INTERVENTION WAS REQUIRED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5489577 ↗