Bralon 170013Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884521126982), received between Jun 17, 2025 and Jun 25, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K934738); they may or may not involve this specific model.

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2025Break; Break

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC HERNIORRHAPHY PARAOESOPHAGEAL SURGERY, THE SURGEON INSERTED THE INSTRUMENT INTO THE TROCAR WITH AT LEAST THREE SUTURES WITHOUT ISSUE. USER NOTICED THAT THE NEEDLE WAS BROKEN ONLY ON THE FOURTH SUTURE. THE BROKEN NEEDLE REMAINED INSIDE THE PATIENT. MISSING NEEDLE PROTOCOL WAS FOLLOWED AND CONTACTED RADIOLOGY. THE RADIOLOGIST CONFIRMED THE PRESENCE OF THE NEEDLE INSIDE THE PATIENT. THE SURGEON RE-ENTERED THE ABDOMINAL CAVITY TO ATTEMPT TO RETRIEVE IT, BUT WITHOUT SUCCESS. THE SURGEON CONTINUED USING THE INSTRUMENT WITH OTHER NEEDLES, AND ALL SUBSEQUENT SUTURES CAME OUT INTACT. IT WAS ALSO REPORTED THAT, THE ASSISTANT NURSE AND SALES REP DID NOT NOTICE THAT THE NEEDLES HAD SHIFTED IN THE SMALL WHITE BOX DURING THE LOADING OF THE INSTRUMENT.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 22325292 ↗
• MalfunctionJun 23, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PARAESOPHAGEAL HERNIORRHAPHY, THE NURSE HAD ENSURED THE SUTURE WAS PROPERLY LOADED ON TO THE INSTRUMENT AND WHEN THE SURGEON INSERTED THE DEVICE INTO THE TROCAR, THE SURGEON IMMEDIATELY NOTICED THAT THE NEEDLE WAS BROKENIN TWO. ON THE SECOND SUTURE, THE NEEDLE WAS NOT PROPERLY PLACED IN THE PACKAGING WHEN OPENED PRIOR TO USE DURING THE PROCEDURE. IT WAS NOTED THAT THERE WAS NO NEEDLE LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 22305911 ↗
• MalfunctionJun 20, 2025Break; Break

  ACCORDING TO THE REPORTER, THE NEEDLE WAS BROKEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297407 ↗
• MalfunctionJun 17, 2025Break; Break

  IT WAS REPORTED THAT THE NURSE HAD ENSURED THE SUTURE WAS PROPERLY LOADED ON TO THE INSTRUMENT AND WHEN THE SURGEON INSERTED THE DEVICE INTO THE TROCAR, THE SURGEON IMMEDIATELY NOTICED THAT THE NEEDLE WAS BROKEN IN TWO. ON THE SECOND SUTURE, THE NEEDLE WAS NOT PROPERLY PLACED IN THE PACKAGING WHEN OPENED PRIOR TO USE DURING A LAPAROSCOPIC PROCEDURE.

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

  MAUDE report 22231394 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K934738. One submission often covers many models, so check the product and lot details in each record.

• Z-2281-2026 · Apr 15, 2026 · Open, Classified
  Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
• Z-2543-2017 · May 3, 2017 · Terminated
  Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU