Bralon 170012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521126975), received between Apr 24, 2017 and Sep 18, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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

• MalfunctionSep 18, 2017Difficult to Open or Close; Human-Device Interface Problem; Difficult to Open or Close; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY IN A LAPAROSCOPIC GASTRIC SLEEVE, THE DEVICE WAS DIFFICULT TO UNLOAD, THEY ATTEMPT TO TIE A KNOT, BUT THE NEEDLE WOULD NOT PASS FROM ONE SIDE TO ANOTHER. THEY USED A NEW DEVICE TO COMPLETE THE CASE AND RESOLVE THE ISSUE. ONCE GIVEN TO THE TECH, THE JAWS WERE SHUT, THE HANDLE WAS JAMMED AND THE NEEDLE WAS STILL INSIDE THE DEVICE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6872577 ↗
• MalfunctionApr 24, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC ROUX-EN-Y PROCEDURE THE NEEDLE ON THE RELOAD FELL OF THE JAWS AND DISENGAGED INTO THE PATIENT. TO COMPLETE THE PROCEDURE, THE PHYSICIAN USED GRASPERS AND RETRIEVED THE NEEDLE, A NEW RELOAD WAS PULLED AND USED WITHOUT ISSUE. THERE WAS NO HARM CAUSED TO THE PATIENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6515279 ↗

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