N/A (REF D-AVHD-DF16)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841898130731), received between May 11, 2021 and Oct 23, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2024Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn

  ON (B)(6)2024, AN INNOVATIVE HEALTH REPRESENTATIVE REPORTED VIA EMAIL THAT THERE WAS A DEVICE WITH A MECHANICAL MALFUNCTION, DEVICE BECOME STUCK IN THE SHEATH UPON REMOVAL AND THE PADDLE PORTION HAS DAMAGE TO IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515945 ↗
• MalfunctionOct 7, 2024Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CHEATER WAS NOT ABLE TO GUIDE THE GRID INTO THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20392610 ↗
• MalfunctionMay 11, 2021Break; Break

  THE TIP OF AN ADVISOR HD GRID CATHETER WAS REPORTED TO BE CRACKED DURING INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810186 ↗