Flexor G56228Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002562288), received between Jan 31, 2017 and Dec 10, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Detachment 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891530 ↗
• MalfunctionMay 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE INVOLVING "TBRANCH/VISCERAL VESSEL PROBING" VIA TRANS-AXILLARY ACCESS, THE SIDE-ARM SEPARATED FROM A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH'S HUB WHEN THE USER CONNECTED A SYRINGE FOR INJECTION OF CONTRAST. THE DILATOR WAS NOT IN THE SHEATH WHEN THE SIDE-ARM SEPARATED, NOR WAS ANY OTHER DEVICE. THE ANATOMY WAS REPORTEDLY NORMAL, AND RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF THE SHEATH. THE PATIENT RECEIVED HEPARIN DURING THE PROCEDURE. A POWER INJECTOR WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH A NEW SHEATH. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19393352 ↗
• MalfunctionJan 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED (VIA A PROSPECTIVE, POST-MARKET, MULTICENTER, OBSERVATIONAL STUDY), DURING A PROCEDURE INVOLVING TREATMENT FOR A THORACOABDOMINAL AORTIC ANEURYSM, THE HUB SEPARATED FROM A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH UPON REMOVAL OF THE DEVICE. PER THE REPORTER, THE HUB SEPARATED DUE TO EXTREME FRICTION WITH THE SHEATH AND WIRES. ACCESS WAS OBTAINED IN THE RIGHT AND LEFT FEMORAL ARTERIES AND THE LEFT AXILLARY ARTERY DURING THE PROCEDURE. THE ACCESS SITE WAS NOT SCARRED, AND THE ANATOMY WAS NOT STENOSED, TORTUOUS, OR CALCIFIED. THE COMPLAINT SHEATH WAS ADVANCED THROUGH AN UNSPECIFIED 12-FRENCH SHEATH VIA THE LEFT AXILLARY ARTERY. RESISTANCE WAS ENCOUNTERED UPON BOTH INSERTION AND REMOVAL OF THE COMPLAINT SHEATH, REPORTEDLY DUE TO AN UNSPECIFIED WIRE THAT WAS INSERTED PARALLEL TO THE DEVICE, INSIDE THE UNSPECIFIED 12-FRENCH SHEATH. THE SHEATH SUCCESSFULLY ACCESSED THE TARGET VESSEL AND PERFORMED AS INTENDED, AND AN UNSPECIFIED BRIDGING STENT WAS DELIVERED THROUGH THE SHEATH. THE HUB SEPARATED AS THE COMPLAINT DEVICE WAS REMOVED OVER AN UNSPECIFIED AMPLATZ STIFF WIRE, BY PULLING FROM THE SHEATH HUB. THE DILATOR WAS NOT REINSERTED PRIOR TO SHEATH REMOVAL. SIDE-BRANCH CATHETERIZATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18598528 ↗
• MalfunctionFeb 11, 2021Material Separation; Unraveled Material; Detachment of Device or Device Component; Material Separation; Unraveled Material; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11314533 ↗
• MalfunctionJul 17, 2020Detachment 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 Consequences Or Impact To Patient

  MAUDE report 10290171 ↗
• MalfunctionJun 10, 2020Detachment 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 Consequences Or Impact To Patient

  MAUDE report 10138719 ↗
• MalfunctionApr 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A T-BRANCH PROCEDURE, TWO FLEXOR HIGH-FLEX ANSEL GUIDING SHEATHS SEPARATED AT THE HUB. ACCESS WAS OBTAINED IN THE BRACHIAL ARTERY FOR CANNULATION OF THE RENAL ARTERY. AN UNKNOWN 5 FRENCH CATHETER AND UNKNOWN HYDROPHILIC WIRE GUIDE WERE USED DURING 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, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9977612 ↗
• MalfunctionJul 17, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, DURING REMOVAL OF TWO FLEXOR HIGH-FLEX ANSEL GUIDING SHEATHS (SAME PRODUCT AND LOT NUMBER FOR BOTH DEVICES), THE "STOP RING" (VALVE) WAS TORN OFF. NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADVERSE EFFECT HAS BEEN REPORTED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7694037 ↗
• MalfunctionJan 31, 2017Material Separation; Material Separation

  INTERNATIONAL CUSTOMER REPORTED THAT "THE VENT GOT TORN OFF." ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. 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 6291431 ↗