NA 0250080314Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327052879), received between Jun 25, 2018 and Mar 22, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2021Break; Break

  IT WAS REPORTED THE DEVICE BROKE DURING PROCEDURE. ADDITIONAL INFORMATION CONFIRMED THAT THE PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11548075 ↗
• InjuryJun 19, 2019Break

  IT WAS REPORTED THAT A PIECE BROKE AND REMAINED INSIDE THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8713424 ↗
• MalfunctionJul 26, 2018Break

  IT WAS REPORTED THAT PIECES BROKEOFF INSIDE PATIENT. BROKEN PIECES WERE SUCCESSFULLY REMOVED FROM PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7724126 ↗
• MalfunctionJun 25, 2018Break

  IT WAS REPORTED THAT THE PRODUCT BROKE INSIDE PATIENT. THE BROKEN PIECES WERE SUCCESSFULLY REMOVED FROM PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7636030 ↗