Flexor G13069Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00827002130692), received between Dec 23, 2016 and Dec 30, 2024 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2024Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A FLEXOR RAABE GUIDING SHEATH UNRAVELED UPON WITHDRAWAL FROM THE PATIENT. THE SHEATH WAS MANUALLY REMOVED FROM THE PATIENT AFTER UNRAVELING. AN X-RAY WAS PERFORMED TO DETERMINE IF ANY PART OF THE DEVICE WAS LEFT IN THE PATIENT; HOWEVER, NOTHING WAS FOUND, AND THE USER WAS REPORTEDLY SATISFIED THAT NO PART OF THE DEVICE REMAINED IN THE PATIENT. 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 21036952 ↗
• MalfunctionOct 30, 2024Unraveled Material; Unraveled Material

  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 20567028 ↗
• MalfunctionJan 24, 2024Peeled/Delaminated; Material Separation; Unraveled Material; Peeled/Delaminated; Material Separation; Unraveled Material

  AS REPORTED, DURING AN UNSPECIFIED VASCULAR CASE, A FLEXOR RAABE GUIDING SHEATH TORE DURING USE. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE SHEATH MATERIAL WAS SEPARATED, BUT HELD TOGETHER BY UNRAVELED COILS. DELAMINATION WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18574909 ↗
• InjuryJun 16, 2023Break; Break

  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 17145336 ↗
• InjuryJun 16, 2023Break; Break

  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 17145328 ↗
• MalfunctionFeb 16, 2023Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT AT THE END OF AN UNSPECIFIED ANGIO PROCEDURE, A FLEXOR RAABE GUIDING SHEATH BEGAN TO UNRAVEL AS THE USER WAS PULLING THE DEVICE OVER A STIFF WIRE FROM THE PATIENT. THE DEVICE WAS ABLE TO BE REMOVED AND REPLACED WITH A DIFFERENT UNSPECIFIED SHEATH TO FINISH THE CASE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WAS NOT ANY UNINTENDED SECTION OF THE DEVICE LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386442 ↗
• MalfunctionJun 29, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085419 ↗
• MalfunctionAug 28, 2019Material Separation; Material Separation

  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 8940537 ↗
• MalfunctionApr 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Patient Involvement

  MAUDE report 8487253 ↗
• InjuryFeb 25, 2019Unraveled Material; Material Split, Cut or Torn; Unraveled Material; Material Split, Cut or Torn

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

  Patient problems: No Code Available

  MAUDE report 8367423 ↗
• InjuryNov 8, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, DURING REMOVAL OF ANOTHER MANUFACTURER'S 0.035 INCH GUIDE WIRE THROUGH THE FLEXOR RAABE GUIDING SHEATH, THE HUB OF THE SHEATH WAS PULLED OFF. ACCORDING TO THE COMPLAINANT, THERE WERE KNOTS ON THE GUIDE WIRE WHICH CAUSED THE HUB TO SEPARATE FROM THE COMPLAINT DEVICE. AT THE TIME OF THE EVENT, THE PHYSICIAN WAS TREATING A STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO REPORT OF DIFFICULT ADVANCEMENT OR REMOVAL. THE PROCEDURE WAS BEING PERFORMED VIA THE IPSALATERAL APPROACH IN THE PATIENT'S RIGHT GROIN AND THE AREA BEING TREATED WAS TORTUOUS BUT NOT CALCIFIED. ADDITIONAL INFORMATION WAS RECEIVED RELATIVE TO THE EVENTS TAKING PLACE DURING REMOVAL OF THE WIRE GUIDE. WHEN THE HUB SEPARATED ONLY THE WIRE GUIDE WAS INSIDE THE COMPLAINT SHEATH. THE PHYSICIAN WAS ABLE TO QUICKLY REMOVE BOTH THE COMPLAINT SHEATH AND THE WIRE GUIDE USING CLAMPS AND BOTH WERE REMOVED TOGETHER. AFTER THE REMOVAL, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT. THERE WAS NO SIGNIFICANT BLOOD LOSS REPORTED.

  Patient problems: No Code Available

  MAUDE report 8051069 ↗
• MalfunctionMay 18, 2018Material Separation; Material Separation

  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 7525423 ↗
• InjuryApr 3, 2018Material Separation; Material Separation

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

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7393451 ↗
• MalfunctionDec 29, 2017Material Separation; Material Separation

  IT HAS BEEN REPORTED THAT A FLEXOR RAABE GUIDING SHEATH DEVICE SEPARATED UPON REMOVAL DURING AN ANGIOGRAM PROCEDURE. THE DEVICE WAS PLACED IN THE PATIENT'S "LEG" AND WAS BEING USED VIA CONTRALATERAL APPROACH. ALTHOUGH ANOTHER MANUFACTURER'S WIRE GUIDE WAS INSIDE THE SHEATH, IT WAS SAID THAT THE PHYSICIAN WAS WITHDRAWING THE SHEATH FROM THE PATIENT WITHOUT HAVING THE DILATOR PLACED WHEN THE SEPARATION OCCURRED. THE PATIENT WAS REPORTED TO HAVE NORMAL BODY HABITUS. NO UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE, NOR HAVE ANY ADVERSE EVENTS BEEN REPORTED REGARDING THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7155022 ↗
• InjuryDec 23, 2016Unraveled Material; Unraveled Material

  AFTER A BTK INTERVENTION, THE DEVICE WAS BEING TAKEN OUT AND IT UNRAVELED INSIDE THE PATIENT'S BODY. THE DILATOR WAS IN PLACE WHILE REMOVING THE SHEATH. THE PHYSICIAN STENTED THE REMAINING PORTION OF THE SHEATH AGAINST THE PATIENT'S VESSEL WALL.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6202285 ↗