Polysorb CL-10-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521040199), received between Aug 30, 2018 and Dec 12, 2023 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CESAREAN SECTION PROCEDURE, THE SURGEON OBSERVED THAT WHEN USING THE SIX SUTURE, THE KNOT-TYING PROCESS CONSISTENTLY RESULTED IN THE SUTURE BREAKING IN THE MIDDLE. ANOTHER PACK OF SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18312831 ↗
• MalfunctionDec 12, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CESAREAN SECTION PROCEDURE, THE SURGEON OBSERVED THAT WHEN USING THE SIX SUTURE, THE KNOT-TYING PROCESS CONSISTENTLY RESULTED IN THE SUTURE BREAKING IN THE MIDDLE. ANOTHER PACK OF SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18312826 ↗
• MalfunctionDec 12, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CESAREAN SECTION PROCEDURE, THE SURGEON OBSERVED THAT WHEN USING THE SIX SUTURE, THE KNOT-TYING PROCESS CONSISTENTLY RESULTED IN THE SUTURE BREAKING IN THE MIDDLE. ANOTHER PACK OF SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18312825 ↗
• MalfunctionDec 12, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CESAREAN SECTION PROCEDURE, THE SURGEON OBSERVED THAT WHEN USING THE SIX SUTURE, THE KNOT-TYING PROCESS CONSISTENTLY RESULTED IN THE SUTURE BREAKING IN THE MIDDLE. ANOTHER PACK OF SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18312814 ↗
• MalfunctionDec 12, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CESAREAN SECTION PROCEDURE, THE SURGEON OBSERVED THAT WHEN USING THE SIX SUTURE, THE KNOT-TYING PROCESS CONSISTENTLY RESULTED IN THE SUTURE BREAKING IN THE MIDDLE. ANOTHER PACK OF SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18312804 ↗
• MalfunctionDec 12, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CESAREAN SECTION PROCEDURE, THE SURGEON OBSERVED THAT WHEN USING THE SIX SUTURE, THE KNOT-TYING PROCESS CONSISTENTLY RESULTED IN THE SUTURE BREAKING IN THE MIDDLE. ANOTHER PACK OF SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18312786 ↗
• MalfunctionJul 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, TWO SUTURES OF DIFFERENT MODEL BROKE EASILY AT THE SWAGE (THE POP OFF DETACHED EASILY WHILE THE NON POP-OFF ALSO DETACHED AT THE SWAGE). ANOTHER SUTURE WAS USED TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15105084 ↗
• MalfunctionJun 3, 2022Detachment of Device or Device Component; Human-Device Interface Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE POPS OFF. THE KNOT WILL NOT SLIDE ON THE SUTURE. IT WAS NOTED AIR KNOT WERE DEVELOPING WHICH WAS NOT IDEAL FOR SUTURING.

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

  MAUDE report 14597141 ↗
• MalfunctionApr 25, 2022Component Missing; Component Missing

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PRODUCT HAD NO NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 14193196 ↗
• MalfunctionSep 22, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE DOCTOR USED SYNTHETIC ABSORBABLE SURGICAL SUTURES,  FOUND THAT THE NEEDLE AND SUTURES WERE DETACHED AND THE SUTURES WERE BROKEN WHEN OPENING THE ORIGINAL PACKAGING. IMMEDIATELY STOPPED USING THEM AND REPLACED THEM WITH NEW AND INTACT NEEDLE TO SUTURE THE PATIENT'S WOUND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512547 ↗
• MalfunctionJan 22, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, DURING OPEN SUBTOTAL GASTRECTOMY PROCEDURE, UPON CLOSING ABDOMEN, THE SUTURE WAS AGING, IT WAS BRITTLE, AND WAS BROKEN INTO PIECES. IT WAS REPLACED WITH ANOTHER PLATE SUTURE FOR USE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9615622 ↗
• MalfunctionFeb 25, 2019Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, JUST RIGHT AFTER OPENING THE PACKAGING, THE NURSE FOUND THE NEEDLE TO BE DEFECTIVE. IT WAS REPORTED THAT THE COLOR WAS NOT PURPLE BUT GRAY. WHEN THE NURSE TRIED TO PULL OUT A SUTURE FROM THE PACKAGING, THE NEEDLE COULD BE PULLED OUT BUT THE THREAD WAS PLACED IN PACKAGING. THE THREAD WAS DETACHED ALREADY IN THE PACKAGING. OTHER SUTURES IN THE OTHER PACKS FROM THE OPENED BOX WERE NOT IN THE REPORTED CONDITION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8366161 ↗
• MalfunctionAug 30, 2018Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN OPENED THE PACKAGE FOUND FRACTURE, PART OF SUTURE WAS FRACTURE DURING OPERATION. THE COMPANY VOLUNTARILY RECALLED THE MODEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7834381 ↗
• MalfunctionAug 30, 2018Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN OPENED THE PACKAGE FOUND FRACTURE, PART OF SUTURE WAS FRACTURE DURING OPERATION. THE COMPANY VOLUNTARILY RECALLED THE MODEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7834369 ↗

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