Check-Flo G12830Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002128309), received between Dec 15, 2017 and Jul 10, 2025 — classified as 3 injuries, 1 malfunction.

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. 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.

• InjuryJul 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  COOK WAS NOTIFIED THAT EXCESSIVE VALVE LEAKAGE FROM THE COOK CHECK-FLOW EXTRA LARGE INTRODUCER OCCURRED DURING A FENESTRATED ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THE COOK CHECK-FLOW EXTRA LARGE INTRODUCER WAS USED TO SUPPORT SHEATH PLACEMENT THROUGH FENESTRATIONS OF A PRE-IMPLANTED EVAR DEVICE. A COOK SALES REPRESENTATIVE WAS PRESENT FOR THE PROCEDURE. DURING THE PROCEDURE: THE COOK CHECK-FLOW EXTRA LARGE INTRODUCER WAS INSERTED OVER A COOK LUNDERQUIST WIRE AND POSITIONED FOR COOK ANSEL SHEATH INSERTION. THE VALVE WAS PUNCTURED TWICE FOR STANDARD FENESTRATED ACCESS. TWO 7F SHEATHS (COOK ANSEL AND A COMPETITOR'S SHEATH) WERE INTRODUCED THROUGH THE 20F COOK CHECK-FLOW EXTRA LARGE INTRODUCER. UPON POSITIONING, PROFUSE VALVE LEAKAGE WAS OBSERVED. THE ANESTHETIC TEAM ADMINISTERED FLUIDS URGENTLY IN RESPONSE TO DROPPING BLOOD PRESSURE. DESPITE EFFORTS TO MITIGATE LOSS, THE PATIENT REQUIRED BLOOD TRANSFUSION PRODUCTS. A PRESSURE BAG WITH HEPARINIZED SALINE WAS CONNECTED TO THE SIDE PORT TO LIMIT BLOOD LOSS. IT WAS ESTIMATED THAT OVER 2 LITERS OF BLOOD WERE LOST. A DECISION WAS MADE TO DEPLOY THE COMPETITOR'S FLARED STENTS AND THE CUSTOM-MADE FENESTRATED DEVICE. HOWEVER, THE LEFT

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22475120 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT STOPPED MOVING HER LEGS AND REQUIRED A TOTAL COLECTOMY THE DAY AFTER AN ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE FOR THE PROXIMAL AORTIC ARCH WAS COMPLETED. THE 67 YEAR-OLD FEMALE PATIENT UNDERWENT SEVERAL PROCEDURES ON (B)(6) 2022. FIRST A SPINAL DRAIN AS WELL AS A LEFT SUBCLAVIAN CORONARY ARTERY (LSCA) BYPASS WERE COMPLETED PRIOR TO THE EVAR PROCEDURE. THE PHYSICIAN ANTICIPATED ISSUES WITH FEMORAL ACCESS AND TIGHT AORTIC BIFURCATION PRIOR TO THE EVAR PROCEDURE. INITIAL ACCESS WAS ESTABLISHED USING GRADUATING DILATOR TRANSITIONS AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOONING PRIOR TO ADVANCING THE 18 FRENCH DELIVERY SYSTEM AND THE COOK CHECK-FLO EXTRA LARGE INTRODUCER (20FRENCH, 40CM SHEATH). INITIALLY THE FENESTRATED COMPONENT WAS PLANNED TO BE ADVANCED UP THE RIGHT HAND SIDE (RHS), THIS WAS SWITCHED TO THE LEFT HAND SIDE (LHS) AFTER THE COOK CHECK-FLO EXTRA LARGE INTRODUCER (20FRENCH, 40CM SHEATH) WOULD NOT TRACK UP THE LHS. COOK GRAFTS IMPLANTED INCLUDED: ZENITH FENESTRATED GRAFT, RPN: FEN-THORACO-ABDOMINAL-GRAFT, ZENITH GRAFT, RPN: PROXIMAL-THORACIC, ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS, RPN: ZTA-P-30-201, Z

  Patient problems: Paralysis; Unspecified Vascular Problem

  MAUDE report 15487020 ↗
• MalfunctionJan 24, 2020Fluid/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 9627159 ↗
• InjuryDec 15, 2017Leak/Splash; Leak/Splash

  AS REPORTED BY THE AREA REPRESENTATIVE, DURING A THORACOABDOMINAL ANEURYSM REPAIR PROCEDURE, THE CHECK-FLO EXTRA LARGE INTRODUCER 20F SHEATH WAS USED ON THE CONTRALATERAL SIDE OF THE PATIENT¿S ANATOMY TO ALLOW ACCESS OF THREE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATHS INTO THE SUPERIOR MESENTERIC ARTERY AND TWO RENAL ARTERIES. THE VALVE ON THE 20F SHEATH LEAKED BLOOD THROUGHOUT THE PROCEDURE AND THE ANESTHESIOLOGIST WAS REQUIRED TO ADMINISTER BLOOD PRODUCTS TO KEEP THE PATIENT STABLE FOR THE REMAINDER OF THE PROCEDURE. THE BLOOD LOSS THAT WAS OCCURRING ALSO REQUIRED THE TWO OPERATING SURGEONS TO SPEED UP THE PACE OF THE PLACEMENT OF THE MATING STENTS INTO THE ARTERIES WHICH THEY WERE NOT COMFORTABLE WITH. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL PATIENT, EVENT AND DEVICE INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY.

  Patient problems: Blood Loss

  MAUDE report 7123244 ↗