GENESIS II 71430512Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010212160), received between Jan 12, 2021 and Jan 21, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2021Break; Break

  IT WAS REPORTED THAT AFTER PROCEDURE THE DEVICE IS BROKEN TRIAL LINER. THE PROCEDURE FINISHED WITH THE SAME DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11210735 ↗
• MalfunctionJan 12, 2021Break; Break

  IT WAS REPORTED THAT A LINER WAS FOUND BROKEN DURING SET UP OR INSPECTION. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11156806 ↗