Polysorb 170071Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521126784), received between Aug 9, 2018 and Aug 15, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

Recalls naming this device

1. Apr 15, 2026Open, Classified

   The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.

   Z-2281-2026 · Root cause: Process control · FDA record ↗

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.

• InjuryAug 15, 2023Use of Device Problem; Detachment of Device or Device Component; Human-Device Interface Problem; Use of Device Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOID COLECTOMY, A COMPLICATION OCCURRED WHILE USING THE SUTURE HANDLE ON THE BLADDER WALL. THE SURGEON SUCCESSFULLY PASSED THE STITCH THROUGH THE FIRST LAYER OF TISSUE. HOWEVER, WHEN ATTEMPTING TO TOGGLE THE STITCH THROUGH THE SECOND LAYER OF TISSUE, IT FAILED TO PASS THROUGH AND INSTEAD BECAME RETAINED IN THE BLADDER. IMAGING WAS DONE THAT DID NOT IDENTIFY THE RETAINED LOAD.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 17553168 ↗
• InjuryAug 9, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE CLOSING THE VAGINAL CUFF DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE NEEDLE CAME OFF OF SUTURE AND WAS EMBEDDED IN THE PATIENT. INSTEAD OF REMOVING THE NEEDLE, THE DOCTOR DECIDED TO LEAVE IT IN THE PATIENT'S TISSUE. THEY REPLACED WITH NEW ITEM TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7768421 ↗

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-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