Performer G08956Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002089563), received between Nov 25, 2014 and Sep 12, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2024Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED, A PERFORMER INTRODUCER WAS MISSING FROM ITS PACKAGING. PER THE REPORTER, A SEAL WAS NOT EVIDENT ON THE DISTAL END OF THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207242 ↗
• InjuryMay 17, 2023Break; Break

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

  Patient problems: Foreign Body In Patient

  MAUDE report 16949734 ↗
• MalfunctionAug 20, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED 29SEP2020. THE PHYSICIAN REPORTED THAT THE SKIN AT THE ACCESS SITE WAS TOUGH AND SCARRED, POSSIBLY RESULTING FROM PREVIOUS PROCEDURES. CALCIFICATION AND TORTUOSITY WERE NOT REPORTED. THE SHEATH WAS ADVANCED OVER AN UNKNOWN LUNDERQUIST WIRE GUIDE, AND ANOTHER MANUFACTURER'S CATHETER AND WIRE GUIDE WERE ADVANCED THROUGH THE SHEATH, AS WELL AS AN UNKNOWN FLUSH CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10431674 ↗
• MalfunctionMar 8, 2019Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8404638 ↗
• MalfunctionJan 8, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, THE VALVE ON THE PERFORMER INTRODUCER WAS BROKEN. BLOOD WAS LEAKING. BLOOD LOSS WAS NOT QUANTIFIED; HOWEVER, NO MEDICAL INTERVENTION WAS REQUIRED. THE PHYSICIAN CHANGED TO ANOTHER MANUFACTURER'S SHEATH TO COMPLETE THE ABDOMINAL ANEURYSM REPAIR PROCEDURE. THE COMPLAINT DEVICE WAS INTRODUCED INTO THE PATIENT'S COMMON FEMORAL ARTERY IN AN IPSELATERAL APPROACH. A .035 GLIDE WIRE WAS IN PLACE THROUGH THE COMPLAINT DEVICE. IT IS NOT KNOWN IF THE PATIENT'S ANATOMY WAS TORTUOUS OR CALCIFIED. 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. ADDITIONALLY, IT WAS REPORTED AN UNKNOWN NUMBER OF SIMILAR ISSUES OCCURRED WITH PERFORMER INTRODUCERS IN THE PAST. PLEASE REFERENCE 1820334-2019-00082 WHICH CAPTURES THESE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8228929 ↗
• MalfunctionFeb 19, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) IN THE AORTA, AFTER INTRODUCING ALL THE EVAR COMPONENTS, THE INTRODUCER WAS SWITCHED FOR A 12 FR PERFORMER INTRODUCER. THE PERFORMER INTRODUCER WAS OBSERVED TO BE HEAVILY LEAKING BLOOD FROM THE VALVE AND HEMOSTASIS WAS UNABLE TO BE MAINTAINED, EVEN WHEN A 0.035 INCH DIAMETER WIRE GUIDE AND CATHETERS (REPORTER SPECIFIED THAT ANOTHER MANUFACTURER'S 5 FR CATHETER WAS USED) WERE PASSED THROUGH THE VALVE. DUE TO THE LEAKAGE, THE PROCEDURE WAS REQUIRED TO BE PERFORMED QUICKLY, BUT WAS ABLE TO BE SUCCESSFULLY COMPLETED. NO INTERVENTION WAS REQUIRED. EVERYTHING WAS PLACED IN THE CENTER OF THE INTRODUCER AND THE MEMBRANE WAS NOT PUNCTURED. ACCESS WAS GAINED THROUGH THE RIGHT LEG VIA A CONTRALATERAL APPROACH. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. IT WAS NOTED THAT SIMILAR EVENTS WITH LEAKAGE HAVE OCCURRED PREVIOUSLY WITH OTHER 12 FR PERFORMER INTRODUCERS (REFER TO MEDWATCH 1820334-2018-00540) AND A 14 FR PERFORMER INTRODUCER (REFER TO MEDWATCH 1820334-2018-00394). PER THE INITIAL REPORTER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7280708 ↗
• MalfunctionAug 8, 2017Kinked; Physical Property Issue

  THE COMPLAINANT REPORTED THAT THE SHEATH WAS INSERTED IN THE LEFT CEPHALIC VEIN AND IT KINKED. IT WAS FURTHER NOTED THAT THERE WERE NICKS ON THE SHEATH THAT HAVE POTENTIAL TO LEAD TO AN ADVERSE CONSEQUENCE. HOWEVER, 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 6773199 ↗
• MalfunctionNov 25, 2014Leak/Splash

  ON (B)(6) 2014, DURING AN INFRA-RENAL GRAFT IMPLANT PROCEDURE ON A MALE PT, WHEN THE DEVICE WAS INTRODUCED IN THE FEMORAL ARTERY IT WAS STREAMING FROM HUB AND SHEATH CONNECTION. IT SEEMED AS THOUGH IT WAS NOT SEALED. THE PHYSICIAN DID AN ANGIOGRAM AND REPLACED WITH A MAIN BODY GRAFT AND COMPLETED THE PROCEDURE SUCCESSFULLY. THE SHEATH WAS IN ONLY TEMPORARILY. NO HARM TO THE PT, AND NO ADDITIONAL PROCEDURES OR INTERVENTION WAS REQUIRED DUE TO THIS OCCURRENCE. THE PT LOST APPROXIMATELY 10CC'S OF BLOOD, NO TRANSFUSION REQUIRED.

  Patient problems: Blood Loss

  MAUDE report 4321814 ↗