Performer G10626Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002106260), received between Feb 19, 2016 and Dec 17, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  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; No Consequences Or Impact To Patient

  MAUDE report 11027271 ↗
• MalfunctionDec 9, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED, PRIOR TO USE DURING AN UNKNOWN PROCEDURE, A HAIR WAS FOUND WITHIN THE SEALED PERFORMER INTRODUCER PACKAGE. THE DEVICE WAS NOT OPENED AND DID NOT MAKE CONTACT WITH THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10976134 ↗
• MalfunctionMar 19, 2020Unsealed Device Packaging; Unsealed Device Packaging

  ACCORDING TO THE INITIAL REPORTER, THE PACKAGING OF A PERFORMER INTRODUCER WAS FOUND "UN-SEALING." THE DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 9854910 ↗
• MalfunctionNov 28, 2017Break; Device Operates Differently Than Expected

  CHECK FLO PERFORMER INTRODUCER MALFUNCTION - DIAPHRAGM DAMAGED. SURGEON PROCEDURAL NOTE INDICATES NO COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7062756 ↗
• MalfunctionOct 30, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A STENTGRAFT PLACEMENT, AFTER THE PERFORMER INTRODUCER WAS INSERTED INTO THE PATIENTS ANATOMY, BLOOD LEAKED FROM THE VALVE OF THE HUB. THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED UTILIZING ANOTHER SHEATH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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 6988236 ↗
• MalfunctionFeb 19, 2016Leak/Splash; Leak/Splash

  AFTER THE DEVICE WAS INSERTED, IT WAS CONFIRMED THAT BLOOD WAS LEAKING FROM THE VALVE. A NEW REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5447963 ↗