Polysorb 170054Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521126616), received between Jun 12, 2017 and Jun 12, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 12, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE. THE NEEDLE BROKE AND FELL INTO THE PATIENT. THE NEEDLE WAS UNABLE TO BE RETRIEVED FROM THE PATIENT AND STILL REMAINS IN THE PATIENT. AN X-RAY WAS PERFORMED TO CONFIRM IF THE NEEDLE IS STILL IN THE PATIENT.

  Patient problems: Foreign Body In Patient; No Code Available; Radiation Exposure, Unintended

  MAUDE report 6634755 ↗

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