Flexor G32194Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002321946), received between May 10, 2018 and May 9, 2025 — classified as 1 injury, 5 malfunctions.

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

• InjuryMay 9, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 20MAY2025. ANTEGRADE ACCESS WAS OBTAINED IN THE LEFT GROIN FOR AN IPSILATERAL APPROACH. THE ANATOMY WAS REPORTEDLY SCARRED. PER THE REPORTER, THE USER WAS PLACING THE SHEATH WHEN THE DISTAL END SEPARATED; THEREFORE, NO OTHER DEVICES WERE USED THROUGH THE SHEATH; HOWEVER, THE REPORTER ALSO STATED THAT RESISTANCE WAS FELT DURING BOTH INSERTION AND REMOVAL OF DEVICES THROUGH THE SHEATH. REPORTEDLY, THE USER ATTEMPTED TO REINSERT THE DILATOR PRIOR TO REMOVAL OF THE SHEATH OVER A WIRE; HOWEVER, THE DILATOR WOULD NOT ADVANCE ALL THE WAY DOWN THE SHEATH.

  Patient problems: Foreign Body In Patient

  MAUDE report 21996981 ↗
• MalfunctionAug 29, 2023Peeled/Delaminated; Material Separation; Unraveled Material; Peeled/Delaminated; Material Separation; Unraveled Material

  AS REPORTED, DURING A PROCEDURE INVOLVING ANGIOPLASTY OF THE RIGHT ILIAC ARTERY, A FLEXOR INTRODUCER SHEATH UNRAVELED UPON ATTEMPTED REMOVAL OF ANOTHER MANUFACTURER'S BALLOON CATHETER. ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY. THE BALLOON HAD BEEN DEFLATED AND NEGATIVE PRESSURE WAS MAINTAINED UPON ATTEMPTED REMOVAL OF THE OTHER MANUFACTURER'S 5-FRENCH, 8X80 BALLOON CATHETER; HOWEVER, THE BALLOON CATHETER WAS NOT ABLE TO BE PULLED THROUGH THE SHEATH. THE SHEATH AND BALLOON CATHETER WERE THEN REMOVED TOGETHER, OVER AN UNSPECIFIED STIFF ANGLED GUIDE WIRE, WITHOUT LOSING WIRE ACCESS. 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 SHEATH, THE SHEATH WAS UNRAVELED AND DELAMINATED, WITH UNRAVELED COILS CONNECTING SEPARATED SHEATH MATERIAL. THE OTHER MANUFACTURER'S BALLOON CATHETER WAS LODGED INSIDE THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641647 ↗
• MalfunctionNov 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED 18NOV2021. THE ACCESS SITE WAS DESCRIBED AS NORMAL, AND THE ANATOMY WAS NOT TORTUOUS, CALCIFIED, OR SCARRED. AN UNKNOWN WIRE AND 5 FRENCH CATHETERS WERE USED THROUGH THE SHEATH, WHICH WAS IN PLACE FOR FORTY-FIVE MINUTES. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788663 ↗
• MalfunctionAug 31, 2020Material Separation; Material Separation

  AS REPORTED, DURING A RIGHT LEG ARTERIOGRAM IN WHICH ACCESS WAS GAINED THROUGH THE SFA A FLEXOR INTRODUCER SHEATH WAS BEING REMOVED WHEN THE HUB SEPARATED FROM THE SHEATH. AS THE USER CONTINUED TO REMOVE THE SHEATH IT SEPARATED TWO MORE TIMES ABOUT A THIRD AND TWO THIRDS OF THE WAY DOWN THE SHEATH. ALL THREE SEGMENTS WERE STUCK TO THE COIL AND MANUALLY PULLED FROM THE PATIENT. ANOTHER SHEATH WAS USED TO COMPLETE THE PROCEDURE. NO PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT. THIS DID NOT RESULT IN THE NEED FOR ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10470914 ↗
• MalfunctionFeb 25, 2019Unraveled Material; Detachment of Device or Device Component; Unraveled Material; 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 Consequences Or Impact To Patient

  MAUDE report 8367463 ↗
• MalfunctionMay 10, 2018Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY USING ANOTHER MANUFACTURER'S DRUG COATED BALLOON (DCB) THROUGH THE FLEXOR INTRODUCER SHEATH, THE BALLOON BROKE OFF IN THE RIGHT EXTERNAL ILIAC ARTERY. THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON THROUGH THE SHEATH BUT WAS UNSUCCESSFUL. UPON REMOVAL OF THE COMPLAINT DEVICE THE BALLOON WAS FOUND TO BE LODGED HALF WAY INSIDE AND HALF WAY OUTSIDE THE SHEATH; THE SHEATH BECAME LOOSE, SEEMED TO BE OVERWORKED, AND THE COILS LOOSENED. A FLUOROSCOPY WAS PERFORMED WHICH SHOWED NO REMAINING BALLOON/FOREIGN BODY WAS LEFT IN THE RIGHT ILIAC ARTERY. THE PHYSICIAN RE-ACCESSED THE RIGHT COMMON FEMORAL ARTERY WITH A 4F MICROPUNCTURE CATHETER TO DO AN ANGIOGRAM TO ENSURE THERE WAS NO DAMAGE TO THE ARTERY. THE MICROCATHETER WAS THEN REMOVED AND PRESSURE WAS HELD, A PRESSURE BANDAGE WAS THEN APPLIED TO ACCESS SITE. 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 7502566 ↗