Check-Flo G07417Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002074170), received between Dec 5, 2017 and Dec 11, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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.

• MalfunctionDec 11, 2025Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED 03MAR2026. THE DEVICE WAS USED AS A TROCAR THROUGH THE UTERINE WALL, THROUGH WHICH NEONATAL AND PREMATURE LAPAROSCOPY INSTRUMENTS ARE HANDLED. THERE WERE NO ISSUES ENCOUNTERED DURING SHEATH INSERTION; HOWEVER, INSTRUMENTS WERE DIFFICULT TO MOBILIZE IN THE ¿DUCT¿, AND THE DEVICE WAS ¿TOO STRONG¿ TO MOBILIZE INSTRUMENTS CORRECTLY. A ¿NSP¿ WIRE WAS USED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777997 ↗
• MalfunctionDec 9, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, DURING INSPECTION UPON ARRIVAL WITHIN A DISTRIBUTION FACILITY, FOREIGN MATTER WAS FOUND INSIDE A PERFORMER INTRODUCER'S STERILE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20877470 ↗
• MalfunctionApr 9, 2024Unraveled Material; Device Damaged Prior to Use; Material Twisted/Bent; Unraveled Material; Device Damaged Prior to Use; Material Twisted/Bent

  IT WAS ORIGINALLY REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, SHEATH PUNCTURE WITH THE PERFORMER INTRODUCER SET WAS USED TO ESTABLISH VENOUS ACCESS. AFTER OPENING, THE USER FOUND THAT THE WIRE GUIDE WAS KINKED AND COULD NOT BE USED. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. UPON INITIAL EVALUATION OF THE RETURNED DEVICE ON (B)(6) 2024, THE WIRE GUIDE COILS WERE FOUND TO BE ELONGATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19074697 ↗
• InjuryDec 5, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PULMONARY VALVULOPLASTY, APPROXIMATELY THREE (3) CENTIMETERS OF THE PERFORMER INTRODUCER BROKE AND SEPARATED FROM THE SHEATH INSIDE OF THE PATIENT. THE SHEATH WAS PLACED IN THE PATIENT'S RIGHT FEMORAL ARTERY THROUGH THE GROIN; ANOTHER MANUFACTURER'S BALLOON WAS BEING UTILIZED THROUGH THE SHEATH DURING THE EVENT. THE SEPARATED PIECE WAS NOT RETRIEVED DURING THE EVENT. FURTHER INFORMATION REGARDING DEVICE RETRIEVAL STATUS WILL BE PROVIDED UPON RECEIPT OF THIS INFORMATION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7083409 ↗