Flexor G09810Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002098107), received between Sep 11, 2017 and Dec 9, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED 10DEC2025. THE PROCEDURE WAS A LEFT TIBIAL ARTERY ANGIOPLASTY. THE ISSUE OCCURRED UPON REMOVAL OF SHEATH. THE ACCESS SITE WAS RIGHT COMMON FEMORAL ARTERY, AND THE TARGET LOCATION WAS LEFT TIBIAL ARTERIES. THE ACCESS SITE WAS NOT SCARRED. THE ANATOMY WAS NOT STENOSED, TORTUOUS OR CALCIFIED. CONTRALATERAL APPROACH WAS USED. THE BIFURCATION ANGLE WAS NOT STEEP OR CALCIFIED. A COOK'S WIRE GUIDE WAS USED IN THE LUMEN OF THE SHEATH WHEN THE ISSUE OCCURRED. ANOTHER MANUFACTURER'S BALLOONS WERE USED THROUGH THE SHEATH DURING THE PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF SHEATH OR ANY OTHER DEVICES THROUGH THE SHEATH. THE SHEATH HUB WAS USED TO PULL THE DEVICE FROM THE PATIENT, AND THE SHEATH TUBING WAS ALSO GRIPPED DURING REMOVAL. THE SHEATH WAS REMOVED ENDOVASCULARLY BY PULLING OUT OF ARTERY DILATION. THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL OF THE SHEATH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757600 ↗
• MalfunctionAug 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HUB OF A FLEXOR INTRODUCER SHEATH SEPARATED FROM THE DEVICE AS THE SHEATH WAS PULLED BACK. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22772965 ↗
• MalfunctionMay 8, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, TWO FLEXOR INTRODUCER SHEATHS FROM LOT 6470720 SEPARATED AT THE HUB DURING REMOVAL. THE PHYSICIAN ACCESSED THE FEMORAL ARTERY TO PERFORM THE ANGIOPLASTY USING AN "UP AND OVER" TECHNIQUE. THE PATIENTS VESSEL WAS NOT SCARRED, TORTUOUS OR CALCIFIED, AND NO RESISTANCE WAS FELT. UPON REMOVAL OF THE FIRST COMPLAINT DEVICE, THE SHEATH SEPARATED AT THE HUB. ANOTHER FLEXOR INTRODUCER SHEATH WAS INSERTED AND IT, TOO, SEPARATED AT THE HUB UPON REMOVAL. A NEW SHEATH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. SOME BLOOD LOSS WAS REPORTED WHICH WAS GREATER THAN EXPECTED BUT WAS NOT QUANTIFIED. ACCORDING TO THE INITIAL REPORTER, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTIONS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7496108 ↗
• InjuryNov 10, 2017Disconnection; Disconnection

  IT WAS REPORTED THAT DURING A PROCEDURE, THE FLEXOR INTRODUCER SHEATH VALVE DISCONNECTED AND THE PATIENT EXPERIENCED SIGNIFICANT BLOOD LOSS. ADDITIONAL INFORMATION REGARDING THE VALVE SEPARATION, PATIENT'S ANATOMY AND OUTCOME, AND QUANTIFICATION OF BLOOD LOSS HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: Blood Loss

  MAUDE report 7023064 ↗
• InjurySep 11, 2017Material Separation; Material Separation

  A FLEXOR INTRODUCER SHEATH WAS USED IN AN ATHERECTOMY. IT WAS REPORTED THAT AFTER THE PHYSICIAN GAINED ACCESS WITH ONE SHEATH IT WAS EXCHANGED FOR THE FLEXOR SHEATH. THE FLEXOR SHEATH WAS USED FOR THE REST OF THE PROCEDURE AND WHEN IT WAS PULLED BACK THROUGH THE IPSILATERAL SIDE, THE PORTION CONTAINING THE VALVE SNAPPED OFF. THE PHYSICIAN USED CLAMPS TO REMOVE THE SHEATH FROM THE PATIENTS BODY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6855789 ↗