Polysorb CL-841Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521042216), received between Nov 8, 2019 and Jul 6, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2020Product Quality Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, WHEN THEY CLOSED THE UTERUS, THE DEVICE MADE THE WOUND BLEED OF NOT MORE THAN 500 CC. THEY USED ANOTHER SUTURE TO SEW THE WOUND. AN ADDITIONAL OPERATION WAS PERFORMED TO CORRECT THE ISSUE. THERE WAS TISSUE DAMAGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available; Tissue Damage; Unspecified Tissue Injury

  MAUDE report 10233568 ↗
• MalfunctionNov 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION OPEN PROCEDURE, THE DEVICES MADE THE WOUND BLED WHEN THE SURGEON CLOSES THE UTERUS MUSCLE. THE SURGEON SEW THE WOUND TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9298071 ↗

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