Flexor G32224Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00827002322240), received between Jan 31, 2017 and Mar 26, 2026 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Peeled/Delaminated

  AS ORIGINALLY REPORTED, DURING INSERTION OF THE DILATOR THROUGH A FLEXOR BALKIN GUIDING SHEATH¿S VALVE, THE TIP OF THE DILATOR BECAME COMPRESSED, PREVENTING IT FROM BEING LOADED ONTO THE WIRE GUIDE AND THEREFORE RENDERING THE DEVICE UNUSABLE. ANOTHER DEVICE WAS USED TO CONTINUE THE ANGIOPLASTY PROCEDURE. THE DILATOR WAS NOT DAMAGED PRIOR TO INSERTION THROUGH THE HUB OF THE SHEATH. PHOTOS OF THE DEVICE WERE LATER PROVIDED BY THE CUSTOMER, SHOWING POSSIBLE DELAMINATION OF MATERIAL. THERE HAS BEEN NO REPORT THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701322 ↗
• MalfunctionJan 16, 2026

  DURING INSERTION OF THE DILATOR THROUGH THE VALVE AT THE PROXIMAL END OF THE SHEATH, THE TIP OF THE DILATOR BECAME COMPRESSED, PREVENTING IT FROM BEING LOADED ONTO THE WIRE AND THUS DEEMING IT UNUSABLE. REPLACEMENT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093612 ↗
• MalfunctionFeb 19, 2025Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED, PRIOR TO PATIENT CONTACT, A FLEXOR BALKIN GUIDING SHEATH'S PACKAGE WAS NOT CLOSED PROPERLY. PER THE REPORTER, THE STERILE SEAL WAS MISSING ON ONE SIDE. THE PACKAGE WAS NOT RIPPED OR TORN. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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 21411921 ↗
• InjuryJun 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962236 ↗
• MalfunctionSep 21, 2020Unraveled Material; Unraveled Material

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10561063 ↗
• MalfunctionJul 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8755044 ↗
• InjurySep 14, 2018Material Separation; Material Separation

  IT WAS REPORTED A PATIENT WAS UNDERGOING AN UNSPECIFIED INTERVENTION OF THE SUPERFICIAL FEMORAL ARTERY WHEN THE FLEXOR BALKIN GUIDING SHEATH BECAME LODGED IN THE ARTERY AND WAS DIFFICULT TO REMOVE RESULTING IN THE SHEATH SEPARATING. DURING THE PROCEDURE THE COMPLAINT DEVICE WAS INSERTED IN THE FEMORAL ARTERY IN A CONTRALATERAL APPROACH. UPON REMOVAL OVER A WIRE THE SHEATH BECAME LODGED IN THE TORTUOUS AND CALCIFIED ARTERY. A SNARE WAS REQUIRED TO REMOVE THE FLEXOR BALKIN GUIDING SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS FINE. 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. THE COMPLAINT DEVICE WILL NOT BE RETURNED FOR INVESTIGATION BECAUSE IT WAS DISCARDED AT THE FACILITY.

  Patient problems: No Code Available

  MAUDE report 7878532 ↗
• InjuryJul 3, 2017Material Separation; Material Separation

  PER THE RECEIVED FDA REPORT, IT WAS REPORTED THAT DURING A LEG ANGIOGRAM PROCEDURE USING A FLEXOR BALKIN GUIDING SHEATH, THE SHEATH GOT STUCK IN THE PATIENT'S LEFT GROIN. THE PATIENT HAD A VERY SCARRED GROIN CAUSING DIFFICULTY TO GAIN ACCESS. THE END USERS WENT THROUGH TWO STANDARD AND FOUR STIFFENED MICROPUNCTURE SETS. THE DEVICE HAD A 6F SHORT SHEATH IN AND WAS SWITCHED OUT FOR A 6F BALKIN. DIFFICULTY WAS NOTED WHEN ADVANCING INTO VESSEL OVER STIFF GLIDEWIRE. THE DECISION WAS MADE TO ABORT THE CASE AND REMOVAL BEGAN WHILE THE DILATOR WAS IN. THE SHEATH SEPARATED AND THEN THE DISTAL PART SEPARATED IN THE BODY AFTER LOSING WIRE ACCESS. THE SHEATH WAS REMOVED SAFELY BY THE PHYSICIAN WITH NO ISSUES. REMAINING PIECES WERE PULLED OUT USING A KELLEY CLAMP. PRESSURE WAS HELD AT THE SITE AND THE PATIENT WAS FINE WITH NO HEMATOMA. THE PATIENT WAS NOT HARMED BUT STAYED OVERNIGHT FOR OBSERVATION. THERE WAS NO UNINTENDED SECTION OF THE DEVICE THAT REMAINED INSIDE THE PATIENT'S BODY. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6684477 ↗
• MalfunctionMay 18, 2017Break; Difficult to Advance

  WHILE PREPPING FOR AN ENDOVASCULAR PROCEDURE IT WAS NOTED THAT THE WIRE WOULD NOT PASS THROUGH THE SHEATH BECAUSE THE TIP OF THE SHEATH WAS CRUSHED. THE DEVICE WAS NOT USED FOR 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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6575905 ↗
• MalfunctionMay 16, 2017Break

  IT WAS REPORTED THAT PRIOR TO PATIENT CONTACT, WHEN THE PHYSICIAN PASSED THE INTRODUCER THROUGH THE GUIDE, THE INTRODUCER TIP WAS NOTED TO BE BROKEN. ANOTHER DEVICE 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6570997 ↗
• MalfunctionMay 15, 2017Crack

  AT THE MOMENT THE DOCTOR TRIED TO PUT THE SHEATH THROUGH THE SKIN INTO THE VESSEL, IT GIVES A CRACK AT THE TIP OF THE SHEATH. A GOUGE IN THE SHEATH TIP CAUSED THE TIP TO BE OUT OF ROUND. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT ASSOCIATED WITH THE OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6567630 ↗
• MalfunctionMay 15, 2017Failure to Advance; Material Integrity Problem

  DURING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CROSSOVER PROCEDURE, UPON ATTEMPTING TO INSERT THE INTRODUCER INTO THE BODY OF THE PATIENT, THE TIP OF THE INTRODUCER WAS NOTED TO BE IRREGULAR (NOT SMOOTH WITH THE DILATOR) AND AS A RESULT, COULD NOT BE ADVANCED. DEVICE IMAGING IDENTIFIED THE TIP OF THE SHEATH IS SPLIT. 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 6567125 ↗
• MalfunctionMay 15, 2017Failure to Advance; Split; Material Integrity Problem

  DURING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, UPON ATTEMPTING TO INSERT THE INTRODUCER INTO THE BODY OF THE PATIENT, THE TIP OF THE INTRODUCER WAS NOTED TO BE IRREGULAR/DAMAGED AND AS A RESULT, COULD NOT BE ADVANCED. ADDITIONALLY, DEVICE IMAGING IDENTIFIED THE TIP OF THE SHEATH IS SPLIT. 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 6567072 ↗
• MalfunctionJan 31, 2017Material Separation; Material Separation

  CUSTOMER REPORTED THAT THE DEVICE WAS USED IN AN ANGIOPLASTY/ LEG RUN-OFF PROCEDURE. THE DEVICE BROKE AT THE HUB WHILE THE ATTENDING WAS ATTEMPTING TO REMOVE THE DEVICE. "EVERYTHING WAS REMOVED FROM THE PATIENT'S BODY" AND THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. 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. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6291507 ↗