ReNew 3291Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811099011729), received between Jun 12, 2025 and Jun 12, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jul 13, 2017Terminated

   The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.

   Z-0507-2018 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2025Fracture; Fracture

  THE TIP BROKE INSIDE THE PATIENT. THE PATIENT WAS NOT HARMED, AND THE GRASPER WAS RETRIEVED INTACT. NO SERIOUS INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194813 ↗