Polysorb CL-892Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521042810), received between Aug 1, 2017 and Jul 10, 2023 — classified as 7 malfunctions.

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

• MalfunctionJul 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE SUTURE PACKAGE WAS OPENED, THE SUTURE NEEDLE WAS FOUND TO BE DETACHED FROM THE SUTURE STRAND.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17293823 ↗
• MalfunctionSep 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VAGINAL HYSTERECTOMY, THE NEEDLE POPPED OFF THE SUTURE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406562 ↗
• MalfunctionAug 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL VAGINAL HYSTERECTOMY, THE SURGEON OPENED FIVE SUTURE PACKS AND EACH HAD THE NEEDLE PULLED OFF THE SUTURE. A NEW BOX WITH A DIFFERENT LOT NUMBER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12336214 ↗
• MalfunctionJun 3, 2021Component Missing; Component Missing

  ACCORDING TO THE REPORTER, UPON OPENING THE DEVICE PRIOR AN OPEN HEART PROCEDURE, THEY FOUND NO NEEDLE IN IT. ANOTHER NEW SUTURE USED WITHOUT ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 11935656 ↗
• MalfunctionJun 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING NEEDLE MOVEMENT WITH CONTINUOUS SUTURING ON CORONARY ARTERY [ARTERIAL] BYPASS GRAFTING, THE THREE (3) PRODUCTS OF THE NON DETACH STANDARD DETACHED FREQUENTLY. A NEW ONE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 11914610 ↗
• MalfunctionAug 21, 2017Break; Break

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE THREAD BROKE. THE DEVICE WAS NOT TREATED/HYDRATED PRIOR TO ITS USE. NO PATIENT INJURY NOTED. THE CURRENT PATIENT STATUS IS NO PROBLEM. A NEW ADDITIONAL SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6807561 ↗
• MalfunctionAug 1, 2017Break; Difficult to Open or Remove Packaging Material; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Open or Remove Packaging Material; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE NEEDLE BROKE DURING A CESAREAN SECTION. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6756772 ↗

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