Flexor G30000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002300002), received between May 18, 2017 and May 31, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED 02AUG2023. THE DILATOR WAS IN PLACE UPON INSERTION OF THE SHEATH INTO THE RIGHT FEMORAL ARTERY (ACCESS SITE). IT IS UNKNOWN IF THE ACCESS SITE WAS SCARRED OR IF RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE DEVICE, AT WHICH POINT THE TIP OF THE SHEATH SPLIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032889 ↗
• MalfunctionDec 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, PRIOR TO PATIENT CONTACT, THE HUB OF A FLEXOR ANSEL GUIDING SHEATH SEPARATED AFTER DISASSEMBLING AND FLUSHING THE DEVICE. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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 12909208 ↗
• MalfunctionApr 30, 2020Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 10014028 ↗
• MalfunctionMay 18, 2017Device Operates Differently Than Expected

  IT WAS REPORTED DURING THE PROCEDURE, WHEN ADVANCING THE DEVICE INTO THE PATIENT 'S BODY FROM THE FEMORAL ARTERY, THE TIP OF THE DILATOR BECAME BURRED. ANOTHER MANUFACTURER'S DEVICE WAS USED FOR THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6577021 ↗