ReNew 3642Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00811099010166), received between Aug 23, 2018 and Jun 13, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

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.

• MalfunctionJun 13, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation

  A BLACK PLASTIC COMPONENT DETACHED AND FELL INTO THE PATIENT'S ABDOMINAL CAVITY DURING THE PROCEDURE.

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

  MAUDE report 22202678 ↗
• MalfunctionFeb 6, 2024Material Fragmentation; Material Fragmentation

  JAW OF THE DEVICE BROKE OFF AND FELL INTO THE PATIENT DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18652905 ↗
• MalfunctionSep 21, 2023Fracture; Fracture

  PART OF THE BLACK TIP WHERE IT HAS MICROLINE WRITING BROKE OFF AND WENT INTO THE PATIENT. THE PIECE HAD TO BE RETRIEVED. THE ACTUALLY PIECE WAS DISPOSED OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17789754 ↗
• MalfunctionMar 29, 2022Fracture; Fracture

  A MICROLINE GRASPER TIP- ONE HALF OF GRASPING JAW APPEARS TO HAVE SHEARED OFF WHILST IN ABDOMEN. BROKEN PIECE REMOVED AND GRASPING TIP REMOVED FROM APPLICATOR WHEN REMOVED FROM ABDOMEN. BOTH KEPT FOR EXAMINATION. SURROUNDING AREA AND TIP CHECKED- EVERYONE HAPPY THAT NOTHING LEFT INSIDE AND ALL PIECES OF TIP RETRIEVED. ALL OTHER GRASPING TIPS WITH SAME LOT NUMBER REMOVED FROM SHELVES AS A PRECAUTION. THERE WAS NO ADVERSE AFFECTS WITH PATIENT. THE PATIENT SUFFERED NO INJURY. THE INCIDENT WAS AN ACTUAL EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13942400 ↗
• MalfunctionAug 23, 2018Material Fragmentation; Insufficient Device Problem Information; Material Fragmentation; Insufficient Device Problem Information

  DURING A SURGICAL PROCEDURE, THE HEAT SHRINK FROM A RENEW SUPER ATRAUMATIC GRASPER TIP WAS FOUND WITH IN THE STOMACH CAVITY OF THE PATIENT. THE HEAT SHRINK WAS RETRIEVED FROM THE PATIENT.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7810613 ↗
• MalfunctionAug 23, 2018Material Fragmentation; Insufficient Device Problem Information; Material Fragmentation; Insufficient Device Problem Information

  DURING A SURGICAL PROCEDURE, THE HEAT SHRINK FROM A RENEW SUPER ATRAUMATIC GRASPER TIP WAS FOUND WITHIN THE STOMACH CAVITY OF THE PATIENT. IT IS UNKNOWN, IF THE FALLEN HEAT SHRINK WAS RETRIEVED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7810611 ↗