Check-Flo G07369Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002073692), received between Sep 12, 2018 and Mar 26, 2025 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE HUB SEPARATED FROM A PERFORMER INTRODUCER. THE DEVICE WAS PLACED IN THE RIGHT FEMORAL ARTERY. AFTER ANOTHER MANUFACTURER¿S UNSPECIFIED STENT CATHETER (DESCRIBED AS A LARGE STENT FOR ILIAC BRANCH BLOOD VESSELS) WAS ADVANCED THROUGH THE SHEATH, THE HUB OF THE SHEATH SEPARATED AND LEAKED BLOOD. THE STENT CATHETER WAS IMMEDIATELY REMOVED. PER THE REPORTER, THE SEPARATED SHEATH SHAFT WENT ¿DEEP INTO THE SKIN SURFACE AND TISSUES¿; HOWEVER, THE SHAFT WAS REPORTEDLY REMOVED BY HAND. A NEW SHEATH OF THE SAME TYPE WAS PLACED, AND THE STENT WAS THEN DELIVERED OVER AN UNKNOWN WIRE GUIDE TO COMPLETE THE PROCEDURE NORMALLY. THE EVENT REPORTEDLY RESULTED IN PROLONGED PROCEDURE TIME AND INCREASED BLEEDING; HOWEVER, THE PATIENT DID NOT REQUIRE ANY TREATMENT FOR BLOOD LOSS. ADDITIONAL INFORMATION REPORTED THAT THE DAMAGE TO THE SHEATH OCCURRED DUE TO ¿CARELESS OPERATION BY THE USER¿ AND NOTED THAT THE CUSTOMER ACCIDENTALLY DAMAGED THE SHEATH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698956 ↗
• MalfunctionSep 4, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20140448 ↗
• InjuryDec 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: Hematoma

  MAUDE report 11101407 ↗
• MalfunctionNov 12, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, WHILE USING A PERFORMER INTRODUCER FOR AN AORTIC OPERATION, THE DILATOR SPLIT THE SHEATH AT THE DISTAL END. THE PHYSICIAN WANTED TO USE THE CODA BALLOON CATHETER TO CANNULATE THE RIGHT LUMEN IN THE PREEXISTING ABDOMINAL PROTHESES. HE ATTEMPTED TO GAIN ACCESS THROUGH THE RIGHT GROIN INTO THE ABDOMINAL AORTA SINCE THERE WAS TORTUOUS, CALCIFIED, OR SCARRED ANATOMY OF THE LEFT SIDE. USING THE MIDDLE SIZE OF THE DILATATOR INCLUDED IN THE PACKAGE, THE BLUE PERFORMER INTRODUCER WAS SPLIT AT THE DISTAL END. THEY USED A NEW, SMALLER SIZE DEVICE TO COMPLETE THE PROCEDURE. THEY NOTED THAT "5000 UNITS" OF HEPARIN WERE GIVEN. THE PATIENT HAS REPORTED AS DOING WELL. 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. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10832522 ↗
• MalfunctionSep 12, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED, DURING THE INSPECTION OF INCOMING PRODUCT, IT HAD BEEN OBSERVED THAT THERE WAS A PARTICLE INSIDE OF SEALED PRIMARY PACKAGING OF THE PERFORMER INTRODUCER. THE DEVICE NEVER MADE PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7869863 ↗