Flexor G12835Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002128354), received between May 17, 2017 and Nov 13, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Crack” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL ANTEGRADE ACCESS IN THE RIGHT FEMORAL ARTERY, THE HUB OF A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH SEPARATED UPON INSERTION AND ADVANCEMENT OF THE DEVICE. THE DEVICE HAD BEEN STORED STACKED IN THE BOX, AND THE PACKAGE WAS NOT DAMAGED. THE ANATOMY WAS REPORTEDLY CALCIFIED, WITH "STRONG CALCIFICATION" IN THE TERMINAL AORTA. A ¿LITTLE¿ RESISTANCE WAS NOTED DURING INSERTION AND/OR REMOVAL OF THE DEVICE OVER ANOTHER MANUFACTURER'S 0.035 INCH, 260 CENTIMETER WIRE, BUT "NOTHING THAT INTERFERED." THE DEVICE CAME APART/SEPARATED AT THE JUNCTION OF THE SHEATH AND HUB. REPORTEDLY, DURING ADVANCEMENT TO THE "DISTAL SIDE", IT "BROKE" WITH THE DILATOR. THE DILATOR WAS NOT DAMAGED. SHARP EDGES WERE NOT NOTED. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S 7 FRENCH SHEATH, AND THE PROCEDURE WAS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 20674368 ↗
• InjuryJul 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH BECAME LOOSE AND LEAKED BLOOD FROM THE Y-CONNECTOR. THE PATIENT UNDERWENT ANGIOGRAPHY, ASPIRATION OF THROMBUS, AND ANGIOPLASTY OF THE RIGHT UPPER LIMB. AFTER THE PROCEDURE, THE PATIENT RETURNED TO THE ROOM AND WAS TREATED WITH AN INDWELLING "ARTERY THROMBOLYTIC TUBE". THE COMPLAINT DEVICE WAS REPORTEDLY INSERTED INTO THE PATIENT ON (B)(6) 2022. THE LAST DOSE OF THROMBOLYTIC (UROKINASE) WAS ADMINISTERED TWO DAYS LATER ((B)(6) 2022) AT 11 AM, AFTER WHICH THE ARTERIAL CATHETER WAS REMOVED AND THE COMPLAINT SHEATH WAS "FIXED" IN POSITION. PER THE USER, THE COMPLAINT DEVICE WAS REMOVED ON (B)(6) 2022; HOWEVER, THE USER ALSO REPORTED THAT AT 12:35 AM ON (B)(6) 2022, THE NURSE NOTED THAT THE "Y VALVE" WAS LOOSE AND ARTERIAL BLOOD WAS FLOWING FROM THE SHEATH. THE USER REPORTED TWO-THIRDS OF BLOOD STAINS ON THE SHEETS WERE FRESH. THE NURSE REPLACED THE VALVE AND NO FURTHER BLEEDING WAS NOTED. THE PATIENT REMAINED CONSCIOUS WITHOUT OBVIOUS SIGNS OF DISCOMFORT. THE PATIENT'S BLOOD PRESSURE WAS 151/108 AND THE HEART RATE WAS 70 BEATS PER MINUTE. THE PATIENT'S HEMOGLOBIN WAS 9.8G/DL. REPORTEDLY, 1.5 UNITS OF BLOOD WAS ADMINISTERED LATER THE SA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15113921 ↗
• MalfunctionSep 26, 2019Fluid/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 Known Impact Or Consequence To Patient

  MAUDE report 9124899 ↗
• MalfunctionApr 2, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED, PRIOR TO PATIENT CONTACT THE DILATOR IN THE FLEXOR SHUTTLE TIBIAL GUIDING SHEATH SPLIT DURING FLUSHING AS IT WAS BEING PREPARED. ANOTHER SHEATH WAS USED TO COMPLETE THE PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PATIENT OUTCOME AND PROCEDURE WERE UNAFFECTED BY THIS OCCURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 8473885 ↗
• MalfunctionMay 25, 2017Fitting Problem; Device Contamination with Chemical or Other Material

  THE COMPLAINANT ALLEGED THAT THE DILATOR DID NOT FIT INTO THE SHEATH NICELY AND THAT THERE WAS AN UNKNOWN BLACK SUBSTANCE ON THE END OF DILATOR. NO ADVERSE EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6590414 ↗
• MalfunctionMay 18, 2017Crack

  WHEN ATTEMPTING TO EXCHANGE SHEATHS, IT WAS NOTED THAT THE END USER WAS UNABLE TO INSERT INTO THE SHUTTLE SHEATH BECAUSE THE DISTAL TIP HAD CRACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6577143 ↗
• MalfunctionMay 17, 2017Crack; Out-Of-Box Failure

  THE REPORTED INFORMATION INDICATED THAT THE HUB WAS NOTED TO BE CRACKED UPON OPENING THE PACKAGE. THIS OCCURRED PRIOR TO USE, SO THERE WERE NO PATIENT INJURIES OR ADDITIONAL MEDICAL INTERVENTION.

  Patient problems: No Patient Involvement

  MAUDE report 6573167 ↗