Flexor G10384Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00827002103849), received between Nov 6, 2014 and Sep 30, 2026 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Detachment of Device or Device Component

  As reported, upon insertion of the device during an unknown procedure, a FLEXOR BALKIN GUIDING SHEATH leaked fluid from the valve. A photo provided by the customer shows separation of the hub and separation of the side-arm tubing. Contralateral access was obtained in the femoral artery. The access site was not scarred or calcified, and the anatomy was not stenosed, calcified, or tortuous. The bifurcation was not steep or calcified. No other devices were used through the sheath during the procedure. Resistance was not encountered during insertion/advancement or removal of the sheath. The leak, hub separation, and side-arm separation occurred during the ¿insertion stage¿. The device was not pulled by the side-arm during the procedure. Another device of the same type, from a different lot, was used to successfully complete the procedure. The patient did not require treatment for blood loss. 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 50947305 ↗
• MalfunctionApr 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, PRIOR TO USE DURING A LOWER LIMB BALLOON DILATION PROCEDURE, A FLEXOR BALKIN GUIDING SHEATH'S DILATOR WAS REMOVED FROM THE SHEATH AND THE HUB SEPARATED. A NEW SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19137965 ↗
• MalfunctionApr 5, 2023Peeled/Delaminated; Contamination /Decontamination Problem; Material Split, Cut or Torn; Peeled/Delaminated; Contamination /Decontamination Problem; 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16683767 ↗
• MalfunctionJun 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE INVOLVING THE LOWER LEG, THE HUB SEPARATED FROM A FLEXOR BALKIN GUIDING SHEATH AS THE USER ATTEMPTED TO READJUST AND PULL BACK ON THE DEVICE. THE SHEATH WAS REMOVED FROM THE PATIENT, AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14756226 ↗
• MalfunctionAug 12, 2021Material Separation; Unraveled Material; Material Separation; Unraveled Material

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12311981 ↗
• MalfunctionJun 1, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  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 10105527 ↗
• MalfunctionFeb 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PLEASE SEE H10.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8310854 ↗
• MalfunctionOct 5, 2018Material Puncture/Hole; Material Puncture/Hole

  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 7937801 ↗
• MalfunctionJul 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  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 7723145 ↗
• MalfunctionSep 19, 2017Material Deformation; Material Deformation

  AN INTERNATIONAL CUSTOMER REPORTED THAT WHEN THE PACKAGE WAS OPENED, THE USER FOUND THE TIP OF THE DILATION SHEATH WAS OUT OF SHAPE. THE USER CHANGED TO ANOTHER NEW DEVICE TO USE. THERE WAS REPORTEDLY NO PATIENT CONTACT, HARM, OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6876599 ↗
• MalfunctionMay 15, 2017Device Damaged Prior to Use; Folded

  IT WAS REPORTED THE CUSTOMER FOUND THE TIP OF THE DILATOR DAMAGED INSIDE THE PACKING. VISUAL INSPECTION IDENTIFIED THE DILATOR TIP WAS FOLDED, CREASED AND HAD HANGNAIL DAMAGE.

  Patient problems: No Information

  MAUDE report 6566990 ↗
• MalfunctionJan 31, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT PRIOR TO PATIENT USAGE, WHILE FLUSHING THE INTRODUCER, THE VALVE WAS FOUND TO BE BROKEN DOWN. NO PATIENT CONTACT WAS MADE. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 6291591 ↗
• InjuryNov 3, 2016Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED DURING A SUPERFICIAL FEMORAL ARTERY PROCEDURE THE INTRODUCER WAS DISCONNECTED FROM THE RING RESULTING IN HEAVY BLEEDING FOR THE PATIENT. ANOTHER INTRODUCER WAS THEN SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. NO FURTHER CONSEQUENCES WERE REPORTED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: Blood Loss

  MAUDE report 6076404 ↗
• InjuryJun 1, 2016Material Separation; Material Separation

  THE PATIENT HAD BILATERAL ILIAC STENTS. DUE TO THE PATIENT HAVING PREVIOUS SURGERY, THERE WAS SCAR TISSUE AT ACCESS SITE. THE PHYSICIAN HAD TO USE 9 FR. DILATOR TO FIT 7FR. SHEATH IN ACCESS SITE. CALCIFICATION WAS NOTED TO BE PRESENT IN ARTERIES. AFTER THE PROCEDURE WAS COMPLETE, THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE; HOWEVER, UPON PULLING BACK ON THE SHEATH, RESISTANCE WAS FELT. DUE TO THE KNOWN ANATOMY, THE DOCTOR PULLED HARDER ON THE SHEATH. THE SHEATH SEPARATED AT THE DISTAL END AND UPON PULLING, THE REMAINING SEPARATED PORTION OF THE DEVICE, IT BEGAN TO UNCOIL. REMOVAL OF THE DEVICE WAS UNSUCCESSFUL BY THE PHYSICIAN AND THE PATIENT WAS EVENTUALLY ADMITTED TO SURGERY. A CUT DOWN WAS PERFORMED TO SUCCESSFULLY REMOVE THE SEPARATED DEVICE. EMAIL RECEIVED (B)(6) 2016: PHYSICIAN'S STATEMENT "I WAS REMOVING THE 7 FRENCH BALKIN SHEATH PRIOR TO CLOSING. THE SHEATH CAME APART AT THE SKIN EDGE. IT HAD PULLED IN TWO LEAVING ONLY THE BRAIDED WIRE. I WAS ABLE TO PUT THE SHEATH DILATOR IN OVER THE WIRE TO TAMPONADE THE BLEEDING AND GRABBED THE REMNANT SHEATH WITH HEMOSTATS, BUT IT ALSO CAME APART. EVENTUALLY PHYSICIAN CAME FOR A CUT DOWN TO EXPOSE MORE OF THE SHEATH. I PUT A BALLOON T

  Patient problems: No Code Available

  MAUDE report 5691863 ↗
• MalfunctionMay 11, 2016Material Separation; Material Separation

  DURING AN ANGIOPLASTY PROCEDURE, THE SHEATH WAS PLACED IN THE FEMORAL WHEN THE HUB SEPARATED. THE DEVICE WAS SUBSTITUTED FOR ANOTHER ONE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT铠BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5648146 ↗
• MalfunctionNov 6, 2014Material Separation

  INFO WAS PROVIDED THAT A PT UNDERWENT A PROCEDURE AND DURING THE EXTRACTION OF THE DILATOR, THE VENT GOT DETACHED FROM SHEATH. ADDITIONAL INFO PROVIDED ON THE COMPLAINT FORM STATED THAT WHEN PULLING OUT THE SHEATH, THE VALVE BROKE OFF THE SHAFT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4254714 ↗