Check-Flo G28999Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002289994), received between Apr 15, 2016 and Oct 21, 2024 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2024Fluid/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: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20494012 ↗
• MalfunctionJul 17, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  COOK WAS NOTIFIED THAT THE HUB OF A CHECK-FLO EXTRA LARGE INTRODUCER HAD SEPARATED. THE FEMALE PATIENT WAS UNDERGOING A PROCEDURE WHERE THE CHECK-FLO EXTRA LARGE INTRODUCER WAS BEING USED. WHEN THE INTRODUCER WAS BEING WITHDRAWN, THE HUB ON THE END OF THE DILATOR SEPARATED IN THE SURGEON'S HANDS. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19764727 ↗
• MalfunctionJun 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO COOK THAT THE VALVE OF A CHECK-FLO EXTRA LARGE INTRODUCER LEAKED. THE PATIENT WAS UNDERGOING A THREE VESSEL FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) TO TREAT A JUXTARENAL ANEURYSM. THE CHECK-FLO EXTRA LARGE INTRODUCER WAS INSERTED INTO THE PATIENT. A DILATOR WAS INSERTED INTO THE CHECK-FLO EXTRA LARGE INTRODUCER. WHEN THE DILATOR WAS REMOVED, BLOOD WAS DRIPPING FROM THE VALVE OF THE CHECK-FLO EXTRA LARGE INTRODUCER. TO CONTINUE THE PROCEDURE, IT WOULD HAVE REQUIRED PUNCTURING THE VALVE OF THE CHECK-FLO EXTRA LARGE INTRODUCER TO INSERT TWO SIX FRENCH SHEATHS AND ONE SEVEN FRENCH SHEATH. AS BLOOD LOSS WAS A CONCERN, THE CHECK-FLO EXTRA LARGE INTRODUCER WAS REMOVED AT THAT POINT IN THE PROCEDURE. ANOTHER CHECK-FLO EXTRA LARGE INTRODUCER WAS PLACED WITH BETTER HEMOSTASIS TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19620238 ↗
• InjurySep 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED ON 07OCT2020. IT WAS REPORTED THAT "3 X 6FR ANSEL SHEATHS" WERE PLACED THROUGH THE CHECK-FLO VALVE DURING THE PROCEDURE. THE PROCEDURE WAS "FINISHED OK, COMPLETED AS NORMAL" AND THE PATIENT WAS DESCRIBED TO BE "DOING WELL."

  Patient problems: Blood Loss; No Code Available

  MAUDE report 10574327 ↗
• MalfunctionMar 11, 2020Failure to Advance; Failure to Advance

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED RELATED TO THE DESCRIPTION OF THE EVENT SINCE THE LAST MEDWATCH REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9820407 ↗
• InjuryNov 2, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE AREA REPRESENTATIVE REPORTED AN UNSPECIFIED PROCEDURE ON A MALE PATIENT. DURING THE PROCEDURE, THE CHECK-FLO EXTRA LARGE INTRODUCER WAS USED. THE 20F SHEATH WAS ADVANCED INTO THE LEFT COMMON ILIAC WHICH WAS NOT TORTUOUS OR CALCIFIED. THE SHEATH WAS TO BE LEFT IN THE ILIAC AND AS THE PHYSICIAN THEN TRIED TO REMOVE THE DILATOR, THE CAP OF THE DILATOR CAME OFF IN THE PHYSICIAN¿S HAND. THEY DILATOR WAS PULLED OUT USING A HEMOSTAT. AS REPORTED, NO PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE AND THERE WERE NO ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 6996397 ↗
• MalfunctionOct 10, 2017Detachment Of Device Component; Loose or Intermittent Connection; Out-Of-Box Failure

  IT WAS REPORTED PARTS OF THE PRODUCT WERE LOOSE. THE SIDE ARM WAS DETACHED FROM THE VALVE UPON DELIVERY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6937678 ↗
• MalfunctionOct 10, 2017Detachment Of Device Component

  ONCE REMOVING THE DILATOR PORTION, THE HUB SEPARATED FROM THE DILATOR. THE DILATOR WAS ABLE TO BE REMOVED BY HAND. PROCEDURE WAS COMPLETED AS INTENEDED FOLLOWING THE INCIDENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE AND 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: Foreign Body In Patient

  MAUDE report 6933978 ↗
• MalfunctionApr 20, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A FENESTRATED ENDOVASCULAR ANEURYSM(FEVAR) REPAIR OF AN ABDOMINAL AORTIC ANEURYSM (AAA) USING A CHECK-FLO EXTRA LARGE INTRODUCER, THE PHYSICIAN ACHIEVED ACCESS IN THE LEFT GROIN. HE REPLACED THE GLIDE WIRE WITH THE LUNDERQUIST WIRE AND INTRODUCED THE 20FR SHEATH OVER THE LUNDERQUIST WIRE. AFTER THE 20FR SHEATH WAS INSERTED TO THE REQUIRED LEVEL, HE ATTEMPTED TO REMOVE THE DILATOR OF THE 20FR SHEATH AND THE MOST DISTAL PORTION/HUB BROKE OFF. HE MANAGED TO GRIP THE TAPERED PORTION OF THE DILATOR TO REMOVE IT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6507989 ↗
• MalfunctionApr 15, 2016Material Separation; Material Separation

  WHILE ADVANCING THE SHEATH WITHIN THE FEMALE PATIENT DURING A AAA PROCEDURE, THE DILATOR WAS DAMAGED DURING ADVANCEMENT AND BROKE OFF WITHIN THE SHEATH. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5582274 ↗