Polysorb CL-842Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521042384), received between Jul 28, 2020 and May 15, 2023 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  DUPLICATE OF (B)(4) ACCORDING TO THE REPORTER, NINETEEN DAYS POSTOPERATIVE TO PERINEAL REPAIR, DEHISCENCE OCCURRED DUE TO THE TWO SUTURES DISSOLVING EARLY. THE SUTURE WAS FOUND TO BE IN VARIOUS STAGES OF DISSOLVING. INTERVENTION WAS REQUIRED TO RESOLVE THE ISSUE.

  Patient problems: Wound Dehiscence

  MAUDE report 16934780 ↗
• InjuryMay 12, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  DUPLICATE OF PE (B)(4) ACCORDING TO THE REPORTER, NINETEEN DAYS POSTOPERATIVE TO PERINEAL REPAIR, DEHISCENCE OCCURRED DUE TO THE TWO SUTURES DISSOLVING EARLY. THE SUTURE WAS FOUND TO BE IN VARIOUS STAGES OF DISSOLVING. INTERVENTION WAS REQUIRED TO RESOLVE THE ISSUE.

  Patient problems: Wound Dehiscence

  MAUDE report 16924004 ↗
• InjuryMay 12, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 13 DAYS POST OPERATIVE A 2ND DEGREE PERINEAL REPAIR AFTER PLACEMENT OF THE SUTURES, WOUND DEHISCENCE WAS FOUND AT ROUTINE FOLLOW-UP. THE SUTURE WAS FOUND TO BE IN VARIOUS STAGES OF DISSOLVING. THE PATIENT REQUIRED INTERVENTION DUE TO THE ISSUE.

  Patient problems: Wound Dehiscence

  MAUDE report 16923244 ↗
• InjuryMay 12, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, NINETEEN DAYS POST OPERATIVE TO A SECOND-DEGREE PERINEAL REPAIR AFTER PLACEMENT OF THE SUTURES, WOUND DEH ISCENCE WAS FOUND AT ROUTINE FOLLOW-UP. THE SUTURE WAS FOUND TO BE IN VARIOUS STAGES OF DISSOLVING. THE PATIENT REQUIRED INTERVENTION DUE TO THE ISSUE.

  Patient problems: Wound Dehiscence

  MAUDE report 16922952 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, POSTOPERATIVE TO OPEN VAGINAL REPAIR, PATIENT HAD SECOND DEGREE DEHISCENCE.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 16870744 ↗
• MalfunctionMay 2, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, AFTER AN OPEN VAGINAL LACERATION REPAIR PROCEDURE, THE PATIENT HAD WOUND DEHISCENCE.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 16854055 ↗
• MalfunctionJul 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, AT THE FIRST STITCH, ON TWO NEEDLES CONSECUTIVELY, THE NEEDLE CAME OFF LIKE DETACHMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10331841 ↗

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