ReNew 3122Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00811099010036), received between Feb 20, 2020 and Dec 26, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. Nov 5, 2024Open, Classified

   A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.

   Z-0663-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2024Fracture; Fracture

  IN ONE CASE, THE HEAT SHRINK FELL INTO THE ABDOMINAL CAVITY AND WAS RETRIEVED AND DISPOSED AT THE HOSPITAL. IN THE OTHER TWO CASES, THE HEAT SHRINK FELL OUTSIDE THE SURGICAL FIELD SO NO HARM TO THE PATIENT. THESE TWO PIECES WERE RETRIEVED AND AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21018735 ↗
• MalfunctionNov 27, 2024Fracture; Fracture

  THE HEAT SHRINK GOT CAUGHT ON THE TROCAR AND CAME OFF AND RETRIEVED. IT DID NOT FALL INTO THE ABDOMINAL CAVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798320 ↗
• MalfunctionOct 24, 2024Fracture; Fracture

  THE HEAT SHRINK CAME OFF DURING THE SURGERY. THE HEAT SHRINK WAS REMOVED FROM THE ABDOMINAL CAVITY, SO THERE WAS NO HEALTH PROBLEM. AS THE EXACT SAME PHENOMENON TOOK PLACE WITH THE SAME LOT, OUR CUSTOMER STOPPED USING THE LOT AND RETURNED TO US.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522575 ↗
• MalfunctionOct 24, 2024Fracture; Fracture

  THE HEAT SHRINK CAME OFF DURING THE SURGERY. THE HEAT SHRINK WAS REMOVED FROM THE ABDOMINAL CAVITY, SO THERE WAS NO HEALTH PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522510 ↗
• MalfunctionOct 15, 2024Fracture; Fracture

  THE HEATSHRINK CAME OFF DURING THE SURGERY. THE HEAT SHRINK WAS REMOVED FROM THE ABDOMINAL CAVITY, SO THERE WAS NO HEALTH PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20456762 ↗
• MalfunctionOct 15, 2024Fracture; Fracture

  THE HEATSHRINK CAME OFF DURING THE SURGERY. THE HEAT SHRINK WAS REMOVED FROM THE ABDOMINAL CAVITY, SO THERE WAS NOT HEALTH PROBLEM.THE TIP WAS DISCARDED SINCE IT WAS USED FOR THE INFECTIOUS DISEASE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20455207 ↗
• MalfunctionDec 15, 2022Material Fragmentation; Material Fragmentation

  DURING THE SURGERY, HEAT SHRINK CAME OFF AND FELL INTO THE ABDOMINAL CAVITY. IT WAS REMOVED FROM THE ABDOMINAL CAVITY AND THERE WAS NO HEALTH PROBLEM FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15991858 ↗
• MalfunctionFeb 20, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  DURING SURGERY, THE SURGEON FOUND THAT THE HEAT SHRINK HAD COME OFF IN THE PATIENT'S ABDOMINAL CAVITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9732214 ↗