Check-Flo G12423Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002124233), received between Feb 3, 2021 and Feb 20, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Unraveled Material; Unraveled Material

  AS REPORTED, UPON OPENING THE PACKAGE PRIOR TO USE FOR AN UNKNOWN PROCEDURE, THE DISTAL END OF A PERFORMER INTRODUCER¿S WIRE WAS ELONGATED/UNRAVELED. THE WIRE DID NOT MAKE PATIENT CONTACT. ANOTHER WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS NOT HOSPITALIZED, DID NOT REQUIRE ANY ADDITIONAL PROCEDURES, AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424021 ↗
• MalfunctionJul 12, 2024Unraveled Material; Unraveled Material

  AS REPORTED, DURING A PROCEDURE INVOLVING TREATMENT OF VARICOSE VEINS WITHIN THE LEG, A WIRE GUIDE INCLUDED WITH A PERFORMER INTRODUCER UNRAVELED UPON REMOVAL OF THE DEVICE. PERCUTANEOUS NEEDLE ACCESS WAS OBTAINED IN THE FEMORAL ARTERY, AND THE ACCESS SITE WAS NORMAL. ULTRASOUND GUIDANCE WAS NOT USED TO OBTAIN ACCESS, AND BLOOD RETURN WAS NOT NOTED UPON INSERTION OF THE ACCESS NEEDLE, PRIOR TO ADVANCEMENT OF THE WIRE GUIDE. THE WIRE WAS ADVANCED THROUGH THE ACCESS NEEDLE, AND THE NEEDLE WAS REMOVED. SLIGHT RESISTANCE WAS REPORTED UPON INSERTION AND/OR REMOVAL OF THE DEVICE COMPONENTS. THE 6-FRENCH SHEATH WAS ADVANCED ALONG THE WIRE. WHEN THE USER ATTEMPTED TO REMOVE THE WIRE, IT COULD NOT BE REMOVED FROM THE SHEATH. WHEN THE WIRE WAS REMOVED, IT WAS FOUND TO BE UNRAVELED. PER THE REPORTER, THE WIRE WAS PULLED BACKWARDS AND/OR REMOVED THROUGH THE ENTRY NEEDLE AT SOME POINT. THE USER IMMEDIATELY REPLACED THE DEVICE TO COMPLETE THE PROCEDURE. A DELAY IN TREATMENT WAS REPORTED; HOWEVER, THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19733408 ↗
• MalfunctionMar 21, 2023Unsealed Device Packaging; Unsealed Device Packaging

  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 16585556 ↗
• MalfunctionJun 10, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A PROCEDURE INVOLVING THE GREAT SAPHENOUS VEIN, THE TIP OF A PERFORMER INTRODUCER SPLIT UPON INSERTION OF THE DEVICE. THE DEVICE WAS FLUSHED WITH HEPARINIZED SALINE AND THE USER ATTEMPTED TO INSERT THE SHEATH AND DILATOR OVER A WIRE GUIDE INTO THE DISTAL GREAT SAPHENOUS VEIN, AT WHICH POINT THE TIP OF THE SHEATH WAS NOTED TO BE SPLIT WITH SHARP EDGES. THE ANATOMY WAS MODERATELY TORTUOUS. THE DEVICE WAS REMOVED AND REPLACED, AND THE PROCEDURE WAS COMPLETED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THERE HAS BEEN NO REPORT THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ANY ADDITIONAL PROCEDURES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14658833 ↗
• MalfunctionFeb 3, 2021Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging 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; No Patient Involvement

  MAUDE report 11274017 ↗