Check-Flo G12831Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002128316), received between Nov 28, 2017 and Nov 15, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2024Failure to Advance; Failure to Advance

  ADDITIONAL INFORMATION WAS PROVIDED ON 13MAR2025. THE FACILITY INDICATED THAT THE DEVICE WAS NOT TECHNICALLY SUCCESSFUL AND DID NOT ACCESS THE INTENDED VASCULATURE DUE TO MODERATE STENOSIS IN THE EXTERNAL ILIAC ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696235 ↗
• InjuryMar 15, 2024Difficult to Advance; Difficult to Advance

  A PATIENT PARTICIPATING IN A COOK CUSTOM MADE DEVICE (CMD) STUDY EXPERIENCED A PERFORATION OR RUPTURE OF THE RIGHT COMMON ILIAC ARTERY DURING THE CMD PROCEDURE. THE PATIENT UNDERWENT A STAGED PROCEDURE. THE FIRST PROCEDURE WAS AN ARCH BRANCH STAGED PROCEDURE ON (B)(6) 2023 AND INCLUDED A LEFT SUBCLAVIAN ARTERY (LSA) TRANSPOSITION. THE PATIENT DID NOT HAVE ANY SIGNIFICANT MEDICAL PROBLEMS OR COMPLICATIONS DURING THE PROCEDURE. NO GRAFTS WERE IMPLANTED, AND NO COOK ANCILLARY DEVICES WERE USED. A COMPLETION ANGIOGRAM WAS NOT PERFORMED DURING THE STAGED PROCEDURE. THE CMD DEVICE WAS MANUFACTURED FOR THIS SPECIFIC PATIENT. THE PATIENT UNDERWENT THE CMD IMPLANT PROCEDURE ON (B)(6) 2023: THE FOLLOWING DEVICES WERE IMPLANTED DURING THE PROCEDURE: NON COOK DEVICES: INNOMINATE STENT: COMPETITORS GRAFT (16MM X 49 MM). PLACEMENT WAS CONSIDERED A TECHNICAL SUCCESS. LEFT SUBCLAVIAN: COMPETITORS GRAFT (12 MM X 38 MM). PLACEMENT WAS CONSIDERED A TECHNICAL SUCCESS. ILIAC COMPONENT PLACED ON THE RIGHT: COMPETITORS GRAFT (10MM X 37 MM) PLACEMENT WAS CONSIDERED A TECHNICAL SUCCESS. ILIAC COMPONENT PLACED ON THE RIGHT : COMPETITORS GRAFT (10 MM X 59 MM). PLACEMENT WAS CONSIDERED A TECHNICAL SUCCESS. IL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18915227 ↗
• MalfunctionApr 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A FENESTRATED REPAIR IN THE AORTA, WHEN TAKING THE DILATOR OUT OF THE SHEATH OF THE CHECK-FLO EXTRA LARGE INTRODUCER OVER A LUNDERQUIST WIRE, THE HUB SNAPPED OFF. THE HUB OF THE DEVICE WAS LATER DISCARDED. THE PROCEDURE CONTINUED WITH NEED TO PLACE THE DILATOR BACK INTO THE SHEATH WHICH WAS IN THE PATIENT. ADDITIONAL INFORMATION WAS PROVIDED ON 10APR2019. THE DEVICE WAS IN THE PATIENT WHEN THE HUB SNAPPED OFF. THE SHEATH WAS IN PLACE AND THE DILATOR WAS BEING REMOVED WHEN THIS OCCURRED. THE HUB OF THE DILATOR WAS THE PORTION THAT SEPARATED, THE SHEATH WAS FINE. BEFORE SEPARATION, THE ONLY THING THAT HAD PASSED THROUGH THE HUB BEFORE IT SEPARATED WAS THE LUNDERQUIST WIRE, AS THE DILATOR WAS INSERTED OVER IT. RESISTANCE WAS EXPERIENCED WHEN THE DILATOR WAS REMOVED. THE CASE WAS FINISHED WITHOUT ANY PATIENT ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8540635 ↗
• MalfunctionNov 28, 2017Material Separation

  HUB SEPARATED FROM DILATOR UPON REMOVAL OF DILATOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7062727 ↗