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Polysorb 170050Recalls & reported problems

Covidien LP · Absorbable Single Stitch Reload · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521126760), received between Jan 11, 2023 and Jan 11, 2023 — 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Break1
  • Detachment of Device or Device Component1

Patient problems

  • Foreign Body In Patient1
  • Unintended Radiation Exposure1
  • Unspecified Tissue Injury1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 11, 2023Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, WHEN CLOSING THE VAGINAL CUFF, THE NEEDLE BROKE IN HALF. A SECOND DEVICE WAS USED AND THE SAME ISSUE OCCURRED WITH THE SAME LOT AND ITEM NUMBER. THE COMPONENT FELL INTO THE PATIENT'S CAVITY. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

    Patient problems: Foreign Body In Patient; Unintended Radiation Exposure; Unspecified Tissue Injury

    MAUDE report 16142072 ↗

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

Other Endoscopic tissue approximation device devices

All Endoscopic tissue approximation device devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.