Performer G28322Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00827002283220), received between Sep 12, 2014 and Feb 10, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED 27MAR2026. THE COMPLAINT DEVICE WAS NOT LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306580 ↗
• MalfunctionFeb 10, 2026Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED 09FEB2026. THE SAME PROVIDER USED THE DEVICES ASSOCIATED WITH PATIENT IDENTIFIERS (B)(6). ACCESS WAS OBTAINED IN THE RIGHT FEMORAL VEIN. THERE WERE NO DIFFICULTIES ADVANCING THE INTRODUCER; HOWEVER, LEAKING WAS NOTED AROUND THE SHEATH. THE USER ATTEMPTED TO ADVANCE ANOTHER MANUFACTURER¿S TRANSSEPTAL NEEDLE THROUGH THE SHEATH. THE ISSUE WAS NOTED AT THE BEGINNING OF THE CASE. IT IS UNKNOWN WHAT CAUSED THE DEVICE TO SPLIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306572 ↗
• MalfunctionJun 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, PRIOR TO PATIENT CONTACT DURING AN UNSPECIFIED CARDIAC PROCEDURE, THE TIP OF A PERFORMER INTRODUCER¿S DILATOR CRACKED. PER THE REPORTER, THE TIP WAS DEFORMED PRIOR TO USE. AS THE PHYSICIAN ATTEMPTED TO USE ¿OTHER INSTRUMENTS¿ TO CORRECT THE DEFORMATION, THE TIP CRACKED. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. PHOTOS PROVIDED BY THE CUSTOMER SHOW A SPLIT IN THE DILATOR TIP. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341377 ↗
• MalfunctionJun 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING A PROCEDURE INVOLVING PLACEMENT OF AN "IMPELLER" DEVICE, THE HUB OF A PERFORMER INTRODUCER LEAKED FROM THE HEMOSTATIC VALVE UPON INSERTION INTO THE RIGHT COMMON FEMORAL ARTERY. THE PACKAGE WAS NOT DAMAGED PRIOR TO USE, AND THE DEVICE HAD BEEN STORED IN A ¿STACKED STATE¿. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF THE INTRODUCER. ANOTHER MANUFACTURER¿S WIRE GUIDE WAS IN THE LUMEN OF THE INTRODUCER WHEN THE BLOOD LEAK OCCURRED. THE INTRODUCER WAS REMOVED, AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO CONTINUE THE PROCEDURE WITHOUT FURTHER PROBLEMS. THE PATIENT DID NOT REQUIRE TREATMENT FOR BLOOD LOSS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195247 ↗
• MalfunctionMay 23, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  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 16988551 ↗
• MalfunctionFeb 15, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  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 16380773 ↗
• MalfunctionMay 19, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE, A PERFORMER INTRODUCER LEAKED FROM THE SIDE PORT AFTER THE DEVICE WAS INSERTED. THE INTRODUCER WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT, WHO HAS RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14435869 ↗
• MalfunctionJun 12, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ADDITIONAL INFORMATION WAS RECEIVED 16JUN2020. THE PACKAGE WAS UNOPENED.

  Patient problems: No Patient Involvement

  MAUDE report 10147891 ↗
• MalfunctionOct 15, 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 9191451 ↗
• MalfunctionJul 22, 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 8812526 ↗
• MalfunctionDec 19, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED, A FOREIGN MATTER LIKE EYELASH WAS CONFIRMED INSIDE THE UNOPENED PACKAGE BY THE DISTRIBUTOR.

  Patient problems: No Patient Involvement

  MAUDE report 8180523 ↗
• MalfunctionDec 29, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A PROCEDURE, THE VALVES OF TWO PERFORMER INTRODUCER SHEATHS (FROM THE SAME LOT NUMBER) CAUSED LARGE AMOUNTS OF LEAKAGE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7154438 ↗
• MalfunctionOct 9, 2017Leak/Splash

  IT WAS REPORTED THAT LEAKAGE FROM THE DEVICE TIP WAS CONFIRMED DURING FLUSHING PRIOR TO PATIENT CONTACT. ANOTHER DEVICE WAS USED INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6931665 ↗
• MalfunctionDec 7, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE THE PHYSICIAN CONFIRMED BLOOD LEAKAGE FROM THE CHECK-FLO VALVE OF BOTH DEVICES BEING USED. THE PROCEDURE WAS FINISHED USING THE DEVICES AND THE PATIENT WAS REPORTED TO HAVE ¿RECOVERED ON (B)(6) 2016.¿ ADDITIONAL INFORMATION REPORTED ¿EXACT AMOUNT OF BLOOD LOSS SUCH AS ¿IN APPROX. CC¿ CANNOT BE DETERMINED THOUGH, BLOOD WAS LOST AS MUCH AS IT PUDDLED ON THE FLOOR. HOSPITALIZATION WAS NOT PROLONGED, AND ALSO NO INTERVENTION OR BLOOD TRANSFUSION WAS CONDUCTED DUE TO THE BLOOD LOSS.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6152150 ↗
• MalfunctionNov 16, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED DURING A STENT GRAFT PLACEMENT PROCEDURE THE INTRODUCER SHEATH WAS INSERTED FROM THE RIGHT GROIN. WHEN THE INTRODUCER WAS REMOVED FOR ANGIOGRAPHY THE PHYSICIAN NOTICED THAT BLOOD WAS LEAKING FROM HUB OF THE SHEATH. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REPORTEDLY "HAD A FAVORABLE OUTCOME." NO OTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6105864 ↗
• MalfunctionSep 12, 2014Material Separation

  THE DEVICE WAS USED DURING THE PROCEDURE OF A STENT GRAFT PLACEMENT ON (B)(6) 2014. WHEN THE DEVICE WAS INSERTED INTO THE CFA, THE SIDE-ARM DETACHED FROM THE DEVICE DUE TO A BLOOD RETURN. THE PHYSICIAN STOPPED USING THE DEVICE AND ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4232647 ↗