Check-Flo G08024Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00827002080249), received between Jan 23, 2017 and Mar 31, 2026 — classified as 6 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Material Split, Cut or Torn

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A PERFORMER INTRODUCER ACCORDIONED/DEVELOPED A SMALL TEAR ¿DURING EXCHANGES¿. A PHOTO PROVIDED BY THE CUSTOMER SHOWS A POSSIBLE SMALL TEAR AT THE TIP OF THE SHEATH. THERE HAS BEEN NO REPORT THAT THE PATIENT REQUIRED ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 24746605 ↗
• MalfunctionNov 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, PRIOR TO PATIENT CONTACT DURING AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE VIA ACCESS IN THE FEMORAL ARTERY, THE TIP OF A PERFORMER INTRODUCER WAS ¿DEFORMED¿, AND A WIRE GUIDE WOULD NOT PASS THROUGH IT. THE DEVICE PACKAGE WAS NOT DAMAGED, AND THE DEVICE WAS NOT SHARP. ANOTHER DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY PROBLEMS. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE ON (B)(6) 2024, THE DILATOR TIP WAS SPLIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696495 ↗
• MalfunctionJan 3, 2024Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  AS REPORTED, PRIOR TO USE DURING PREPARATION FOR A FARAPULSE ABLATION PROCEDURE, A PERFORMER INTRODUCER'S TIP WAS IRREGULAR AND SHARP. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER INTRODUCER WAS USED TO COMPLETE THE PROCEDURE. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, A FIBER FROM THE SHEATH TIP WAS HANGING FROM THE DAMAGED TIP. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18438111 ↗
• InjuryMay 12, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 12MAY2023. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY TO TARGET THE SUPERFICIAL FEMORAL ARTERY. THE ACCESS SITE WAS NOT SCARRED, BUT THE ANATOMY WAS SLIGHTLY TORTUOUS AND CALCIFIED. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE DEVICE OVER ANOTHER MANUFACTURER'S WIRE GUIDE. THE SEPARATED DILATOR TIP WAS REMOVED FROM THE BLOOD VESSEL USING A "HOMEMADE" TRAP/CATCHER.

  Patient problems: Foreign Body In Patient

  MAUDE report 16920621 ↗
• MalfunctionFeb 22, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED PROCEDURE, FOREIGN MATTER WAS FOUND INSIDE THE PACKAGING OF A PERFORMER INTRODUCER. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT AND THE PROCEDURE WAS COMPLETED USING ANOTHER NEW UNSPECIFIED DEVICE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16422248 ↗
• MalfunctionJan 4, 2021Difficult to Remove; Material Perforation; Difficult to Remove; Material Perforation

  ADDITIONAL INFORMATION PROVIDED ON 12FEB2021: THERE WAS NO HOLE AT THE END OF THE INTRODUCER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11108452 ↗
• MalfunctionFeb 11, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 8326018 ↗
• MalfunctionDec 11, 2018Fluid/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 8150844 ↗
• InjuryNov 30, 2018Fluid/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: Blood Loss

  MAUDE report 8119810 ↗
• InjuryNov 30, 2018Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT WAS MADE AVAILABLE SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. THIS INFORMATION IS DETAILED.

  Patient problems: Blood Loss

  MAUDE report 8119769 ↗
• MalfunctionNov 12, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED, FOREIGN MATTER WAS CONFIRMED INSIDE THE UNOPENED PACKAGE UPON RECEIPT BY THE DISTRIBUTOR. THE DEVICE NEVER MADE PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8061445 ↗
• MalfunctionAug 30, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, THE PERFORMER INTRODUCER EXPERIENCE LEAKING DURING AN UNSPECIFIED PROCEDURE. DURING THIS PROCEDURE, WHILE A BALLOON CATHETER WAS BEING ADVANCED THROUGH IT, THERE WAS SOME BLOOD LEAKAGE FROM THE HEMOSTATIC VALVE. THE PHYSICIAN REPLACED THE DEVICE WITH ANOTHER PERFORMER INTRODUCER FROM THE SAME LOT, AND EXPERIENCED A SIMILAR ISSUE. THE AMOUNT OF BLOOD LOST IS UNKNOWN, BUT IT WAS CONFIRMED THAT A TRANSFUSION WAS NOT NECESSARY. THE PHYSICIAN THEN USED ANOTHER MANUFACTURER'S DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 Known Impact Or Consequence To Patient

  MAUDE report 7833976 ↗
• MalfunctionApr 17, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN UNSPECIFIED STENT GRAFT PLACEMENT VIA THE FEMORAL APPROACH, THE RCF-14.0-38-J PERFORMER INTRODUCER WAS OBSERVED LEAKING A LARGE AMOUNT OF BLOOD FROM THE HEMOSTATIC VALVE. REPORTEDLY, THE INTRODUCER WAS REPLACED WITH ANOTHER RCF-14.0-38-J PERFORMER INTRODUCER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PER THE INITIAL REPORTER, THE AMOUNT OF BLOOD LOSS WAS UNABLE TO BE QUANTIFIED; HOWEVER, THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION AS A RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7437572 ↗
• InjuryApr 17, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING IMPLANT OF AN ABDOMINAL ENDOPROSTHESIS VIA FEMORAL ACCESS, THE PERFORMER INTRODUCER CONTINUED TO LEAK THE PATIENT'S BLOOD. THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED; HOWEVER, THE PATIENT'S HEMOGLOBIN DROPPED TO 7.0 AS A RESULT OF THE BLOOD LOSS. A BLOOD TRANSFUSION WAS REQUIRED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT'S OUTCOME IS "FINE". DURING THE PROCEDURE, THE INTRODUCER'S HYDROPHILIC COATING WAS ACTIVATED WITH PHYSIOLOGICAL SOLUTION. A 0.035 GUIDE WIRE DEVICE WAS THE ONLY DEVICE BEING UTILIZED THROUGH THE INTRODUCER AS IT WAS USED ONLY TO PERFORM THE SELDINGER TECHNIQUE AND MAINTAIN PATENCY OF THE FEMORAL ARTERY WHILE THE SURGEONS WORKED ON THE CONTRALATERAL SIDE OF THE PATIENT'S LEG. IT WAS NOTED THAT THE ANATOMY OF THE PATIENT'S ILIAC ARTERY WAS GOOD - NO REPORTED CALCIFICATION/ TORTUOSITY.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 7437399 ↗
• MalfunctionFeb 28, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING IMPLANT OF AN ABDOMINAL ENDOPROSTHESIS, THE 14 FR PERFORMER INTRODUCER CONTINUED TO LEAK THE PATIENT'S BLOOD WHILE BEING USED TO PERFORM FEMORAL SURGICAL ACCESS VIA THE GROIN TO INTRODUCE THE ENDOPROSTHESIS. THE LEAK FROM THE INTRODUCER WAS UNABLE TO BE STOPPED; THE SAME ISSUE WAS NOTED TO HAVE BEEN ENCOUNTERED WITH SEVERAL OTHER INTRODUCERS (12 FR INTRODUCER SPECIFIED - REFER TO MEDWATCH 1820334-2018-00574). DURING THIS CASE, THE INTRODUCER'S HYDROPHILIC COATING WAS ACTIVATED WITH PHYSIOLOGICAL SOLUTION. NO OTHER DEVICES WERE BEING UTILIZED THROUGH THE INTRODUCER AS IT WAS USED ONLY TO PERFORM THE SELDINGER TECHNIQUE AND MAINTAIN PATENCY OF THE FEMORAL ARTERY WHILE THE SURGEONS WORKED ON THE CONTRALATERAL SIDE OF THE PATIENT'S LEG. IT WAS NOTED THAT THE ANATOMY OF THE PATIENT'S ILIAC ARTERY WAS GOOD - NO REPORTED CALCIFICATION/ TORTUOSITY. A COOK MEDICAL ZENITH ALPHA ABDOMINAL ENDOVASCULAR GRAFT WAS ADDITIONALLY USED DURING THIS CASE. THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED; THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES/ INTERVENTION DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7303052 ↗
• MalfunctionFeb 8, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A FENESTRATED GRAFT PROCEDURE IN THE ABDOMINAL AORTA, THE 14 FR PERFORMER INTRODUCER WAS LEAKING AT THE VALVE NEAR/ WHILE A WIRE GUIDE WAS IN THE MIDDLE OF THE VALVE. THE PHYSICIAN STATED THAT THIS ISSUE HAS OCCURRED ON PREVIOUS OCCASIONS DURING THE LAST SEVERAL MONTHS (REFER TO MEDWATCH 1820334-2018-00392); AN EIGHT (8) FR SHEATH WAS/ IS PLACED INSIDE OF THE LUMEN OF THE 14 FR INTRODUCER TO STOP THE LEAKAGE. THE PATIENT LOST A LOT OF BLOOD (UNKNOWN QUANTITY) DURING THE PROCEDURE; HOWEVER, A BLOOD TRANSFUSION WAS NOT REQUIRED. THE GRAFT WAS INITIALLY UNABLE TO BE PLACED; HOWEVER, THE PHYSICIAN RE-ATTEMPTED AND THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7251205 ↗
• MalfunctionNov 28, 2017Split; Split

  IT WAS REPORTED THAT PRIOR TO USE UPON OPENING, THE PLASTIC END OF THE PERFORMER INTRODUCER WAS NOTED TO BE SPLIT. THE INTRODUCER DID NOT COME INTO CONTACT WITH A PATIENT AS IT WAS NOT USED.

  Patient problems: No Patient Involvement

  MAUDE report 7064198 ↗
• InjuryOct 10, 2017Break

  THE DILATORS BREAKS AT THE TOP IN CALCIFIED VESSELS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6936139 ↗
• MalfunctionOct 10, 2017Break

  THE DILATORS BROKE AT THE TOP IN A CALCIFIED VESSELS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 6936091 ↗
• MalfunctionOct 10, 2017Material Frayed

  IT WAS REPORTED DURING AN UNSPECIFIED PROCEDURE, AFTER ACCESS WAS GAINED FROM THE RIGHT FEMORAL ARTERY, THE USER FELT "SOME UNCORFORTABLE FEELING" WHEN ADVANCING THE INTRODUCER OVER THE WIRE GUIDE. UPON REMOVING THE INTRODUCER FROM THE PATIENT'S BODY, THE TIP OF THE SHEATH WAS CONFIRMED TO BE FRAYED. AS A RESULT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6935921 ↗
• MalfunctionOct 9, 2017Break

  IT WAS REPORTED DURING THE PATIENT'S ENDOVASCULAR ANEURYSM REPAIR PROCEDURE, AFTER ACCESS WAS GAINED FROM THE RIGHT FEMORAL ARTERY, THERE WAS AN UNSUCCESSFUL ATTEMPT TO INSERT THE DEVICE INTO THE PATIENT'S BODY. AS A PRECAUTIONARY MEASURE TO THE POSSIBLE EFFECTS OF TIP DAMAGE (NICK IN SHEATH TIP), THE PHYSICIAN USED ANOTHER DEVICE (14FR) TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6932073 ↗
• MalfunctionOct 9, 2017Split

  UPON OPENING THE DEVICE PACKAGE, THE USER NOTICED THAT THE INTRODUCER TIP WAS MISSING. IT WAS FURTHER NOTED THAT THE TIP OF THE SHEATH WAS SPLIT. THEREFORE, THE DEVICE DIDN'T MAKE PATIENT CONTACT AND ANOTHER DEVICE OF THE SAME KIND WAS USED INSTEAD.

  Patient problems: No Patient Involvement

  MAUDE report 6930329 ↗
• MalfunctionSep 22, 2017Fluid/Blood Leak; Fluid/Blood Leak

  A PERFORMER INTRODUCER WAS USED IN AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT, AFTER INSERTING A WIRE GUIDE INTO THE VESSEL, THE INTRODUCER DEVICE WAS PLACED; HOWEVER, IT WAS DIFFICULT TO USE DUE TO BLOOD LEAKAGE FROM THE VALVE. THE DEVICE WAS REMOVED AND RE-INSERTED BUT THE SAME THING OCCURRED. THE PHYSICIAN USED ANOTHER PERFORMER INTRODUCER TO COMPLETE THE PROCEDURE. IT WAS REPORTED THERE WAS MORE BLOOD LOSS THAN NORMAL; HOWEVER, THE EXACT AMOUNT WAS UNABLE TO BE DETERMINED. NO MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED DUE TO THE BLOOD LOSS. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: Blood Loss

  MAUDE report 6887079 ↗
• MalfunctionSep 7, 2017Material Deformation; Material Deformation

  AN INTERNATIONAL CUSTOMER REPORTED THAT HEN THE PHYSICIAN ATTEMPTED TO INSERT A PERFORMER INTRODUCER SHEATH INTO THE PATIENT'S BODY, DAMAGE TO THE TIP OF THE SHEATH WAS OBSERVED. IT WAS REPLACED WITH ANOTHER PERFORMER INTRODUCER FROM ANOTHER LOT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6849514 ↗
• MalfunctionMay 5, 2017Material Frayed; Material Frayed

  IT WAS REPORTED FROM THE USER FACILITY THAT WHILE EXCHANGING A SHEATH DURING A PROCEDURE FOR ATRIAL FIBRILLATION ABLATION THE MEDICAL TEAM NOTICED THE TIP OF THE PERFORMER INTRODUCER DILATOR BEGAN TO FRAY. IT WAS REPLACED WITH A NEW ONE AND THE CASE PROCEEDED. AT THE END OF THE PROCEDURE WHEN REMOVING THE SHEATHS, THE NEW ONE HAD ALSO FRAYED. BOTH WERE SET ASIDE. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE WAS REPORTED TO BE SUCCESSFUL AND THE PATIENT WAS LAST REPORTED TO BE STABLE. BOTH COMPLAINT DEVICES ARE FROM THE SAME LOT AND SHALL BE REPRESENTED IN THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6548022 ↗