Polysorb CL-779Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521041790), received between Jan 30, 2018 and Jan 30, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K963253, K981935); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJan 30, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING THE REMOVAL OF UTERUS CYST, WHILE THE DOCTOR WAS PASSING THE NEEDLE FROM THE UTERUS, EMPLOYING A CONTINUED TECHNIQUE, THE NEEDLE SUDDENLY BROKE. SURGERY EXTENDED FOR MORE THAN AN HOUR, BECAUSE IT WAS DIFFICULT FOR THE DOCTOR TO FIND THE BROKEN NEEDLE. PATIENT WAS NOT INJURED OR JEOPARDIZED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7228856 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963253, K981935. One submission often covers many models, so check the product and lot details in each record.

• Z-2601-2018 · Jun 15, 2018 · Terminated
  Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
• Z-2541-2017 · May 3, 2017 · Terminated
  Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VI