ReNew 3221Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00811099011651), received between Jul 15, 2019 and Mar 3, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Break; Fracture

  THE TIP OF THE LAPAROSCOPIC GRASPER INSTRUMENT BROKE DURING A NORMAL PROCEDURE. A METAL PART OF THE INSTRUMENT FRACTURED, CREATING A RISK THAT SMALL METAL FRAGMENTS COULD HAVE ENTERED AND REMAINED IN THE PATIENT'S ABDOMINAL CAVITY. THE BROKEN TIP WAS RETRIEVED, AND ALL PIECES APPEARED TO BE ACCOUNTED FOR.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24499921 ↗
• MalfunctionJun 5, 2025Fracture; Fracture

  THE TIP BROKE OFF INTO THE ABDOMEN OF THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 22152435 ↗
• MalfunctionDec 6, 2024Fracture; Fracture

  A PART OF THE TIP BROKE AND FELL DOWN INTO PATIENT BODY AFTER GOING INTO TROCARS.

  Patient problems: Insufficient Information

  MAUDE report 20863664 ↗
• MalfunctionAug 7, 2024Fracture; Fracture

  LAPAROSCOPIC FENSTRATED GRASPING TIP CAME APART WHILE INSIDE PATIENT, PIECES OF TIP REMOVED BY SURGEON AND PORTION OF TIP RETURNED TO MDRD CARE OF WRITER. FENESTRATED TIP FELL APART (AT THE JAWS) INSIDE THE PATIENT DURING LAPAROSCOPIC SURGERY. ALL PIECES WERE REMOVED LAPAROSCOPICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934418 ↗
• MalfunctionOct 23, 2020Fracture; Fracture

  DURING A PROCEDURE THE JAW BROKE AND FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10730295 ↗
• MalfunctionJul 15, 2019Mechanical Jam; Mechanical Jam

  DURING ROUTINE USE IN A LAPAROSCOPIC CHOLECYSTECTOMY THE GRASPER SUDDENLY STOPPED FUNCTIONING. THERE WAS NO HARM TO THE PATIENT.; THE ANESTHESIA TIME MAY HAVE BEEN INCREASED SLIGHTLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8788902 ↗