Polysorb 170096Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521126838), received between Nov 27, 2018 and Nov 27, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (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.

• MalfunctionNov 27, 2018Entrapment of Device; Product Quality Problem; Entrapment of Device; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLON RESECTION PROCEDURE, WHEN USING THE DEVICE, THE DOCTOR COMPLAINED THAT THE SUTURE IS DIFFICULT TO PASS THROUGH THE NEEDLE HOLE AND THE WAY THE SUTURE WAS ATTACHED TO THE NEEDLE WAS CHANGED. THE SUTURE WAS ALSO VERY PLIABLE AND HE HAD TO USE A LOT OF FORCE FOR IT TO GO THROUGH THE TISSUE. IT WAS SO DIFFICULT THAT THE BOWEL TORE MORE JUST BY USING THE SUTURE. THE HANDLE WORKED LIKE NORMAL. ANOTHER SUTURE RELOAD AND THE SAME HANDLE WAS USED TO COMPLETE THE PROCEDURE. THE NEW SUTURE USED TO BE ALSO NOT FLUSH WITH THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient; Tissue Damage

  MAUDE report 8107002 ↗

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