Polysorb 170055Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521126609), received between Jun 25, 2018 and Jun 25, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Human-Device Interface Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2018Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE FIRST DEVICE WOULD NOT TOGGLE PROPERLY ON THE VERY FIRST RELOAD. IT WAS DIFFICULT TO LOAD AND UNLOAD AS THE SEEMED TO HAVE BEEN MISALIGNED. THEY WORKED ON THE TOGGLES TO "LOOSEN" IT UP AND WERE ABLE TO FINISH THE STITCH BUT REQUESTED A NEW HANDLE. THE SUTURE WAS ALSO FRAYING CLOSE TO THE NEEDLE. THE SECOND DEVICE HAD DIFFICULTY TOGGLING THROUGH THICK TISSUE. THE SURGEON SAID SHE HAD TO WORK INTO THE TISSUE TO GET IT TO TOGGLE. THE NEEDLE WOULD NOT TRANSFER EASILY IT LEFT A SLIGHT LARGER HOLE IN THE TISSUE BECAUSE THE TISSUE NEEDED TO BE REMOVED FROM THE DEVICE WITH A GRASPER. IT WAS OVER SEWN.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 7633887 ↗

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