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Integra® Jarit® 121210Recalls & reported problems

Integra Lifesciences Production Corporation · Integra® Jarit® Heaney Needle Holder, 8", Carb-Bite, Curved · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780377474), received between Apr 26, 2023 and Jul 26, 2023 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionJul 26, 2023Break; Break

    DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY AND CYSTOSCOPY THE SURGEON NOTICED THAT A PIECE OF THE NEEDLEHOLDER HAD BROKEN OFF IN THE PATIENT'S VAGINA WHILE SUTURING THE VAGINAL CUFF. THE PIECE WAS RETRIEVED AND THE INSTRUMENT AND BROKEN PIECE WERE IMMEDIATELY REMOVED FROM THE FIELD. AN X-RAY WAS NOT NECESSARY. THE PROCEDURE WAS COMPLETED AS PLANNED. NO PATIENT HARM OR SURGICAL DELAY OCCURRED AS A RESULT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17399155 ↗
  • MalfunctionApr 26, 2023Break; Break

    N/A.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16820968 ↗

Other HOLDER, NEEDLE, GASTROENTEROLOGIC devices

All HOLDER, NEEDLE, GASTROENTEROLOGIC devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.