Polysorb CLT-21-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521044548), received between Sep 22, 2017 and Oct 21, 2025 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE PRODUCT WAS OPENED AND CHECKED, A BROWN JELLY WAS ATTACHED TO IT. ANOTHER PACKET WAS OPENED FOR INSPECTION, THERE WAS NO PROBLEM, BUT IT WAS SCARY, SO IT WAS NOT USED. UPON INSPECTION OF THE DEFECTIVE PRODUCT, IT WAS ABLE TO CONFIRM THAT THE SUTURE APPEARED TO HAVE UNDERGONE HYDROLYSIS. IT IS ASSUMED THAT THE HYDROLYZED SUTURE APPEARED AS A BROWN JELLY-LIKE SUBSTANCE. ANOTHER SUTURE FROM OTHER LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351250 ↗
• MalfunctionMay 23, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE NURSE OPENED THE PACKET, IT WAS SUPPOSED TO HAVE FIVE UNITS BUT THERE WERE ONLY FOUR UNITS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19388121 ↗
• MalfunctionApr 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE NURSE WAS TAKING OUT THE EQUIPMENT AND TOOK OUT THE THREAD FROM THE PACKAGE, THE NURSE CLAMPED THE NEEDLE WITH A NEEDLE HOLDER AND WHEN THE NURSE PULLED IT OUT, THE NEEDLE AND THREAD DETACHED EASILY. IT WAS NOTED THAT IT OCCURRED ON FOUR SUTURES IN THE SAME PACKAGE IN A ROW. IT WAS NOTED THAT A NEW SUTURE WAS USED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214698 ↗
• MalfunctionApr 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE NURSE WAS TAKING OUT THE EQUIPMENT AND TOOK OUT THE THREAD FROM THE PACKAGE, THE NURSE CLAMPED THE NEEDLE WITH A NEEDLE HOLDER AND WHEN THE NURSE PULLED IT OUT, THE NEEDLE AND THREAD DETACHED EASILY. IT WAS NOTED THAT IT OCCURRED ON FOUR SUTURES IN THE SAME PACKAGE IN A ROW. IT WAS NOTED THAT A NEW SUTURE WAS USED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214694 ↗
• MalfunctionApr 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE NURSE WAS TAKING OUT THE EQUIPMENT AND TOOK OUT THE THREAD FROM THE PACKAGE, THE NURSE CLAMPED THE NEEDLE WITH A NEEDLE HOLDER AND WHEN THE NURSE PULLED IT OUT, THE NEEDLE AND THREAD DETACHED EASILY. IT WAS NOTED THAT IT OCCURRED ON FOUR SUTURES IN THE SAME PACKAGE IN A ROW. IT WAS NOTED THAT A NEW SUTURE WAS USED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214657 ↗
• MalfunctionApr 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE NURSE WAS TAKING OUT THE EQUIPMENT AND TOOK OUT THE THREAD FROM THE PACKAGE, THE NURSE CLAMPED THE NEEDLE WITH A NEEDLE HOLDER AND WHEN THE NURSE PULLED IT OUT, THE NEEDLE AND THREAD DETACHED EASILY. IT WAS NOTED THAT IT OCCURRED ON FOUR SUTURES IN THE SAME PACKAGE IN A ROW. IT WAS NOTED THAT A NEW SUTURE WAS USED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214449 ↗
• MalfunctionApr 19, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROTOMY GASTROINTESTINAL SURGERY, ON WOUND CLOSURE, THE THREAD BROKE. THE FIRST PACKET WAS DISCARDED, BUT SEVERAL SUTURES WERE CUT. THE SECOND PACKET WAS CUT OUT AS WELL, SO THE SUTURE ONE IN THE PACKET WAS CUT OFF WHEN IT WAS TOUCHED A LITTLE BIT, SO IT WAS KEPT. 12 PACKETS WERE REPORTED, ONE PACKET THAT WAS DISPOSED OF AND NOT COLLECTED, ONE DEFECTIVE PRODUCT, ONLY TWO OF THE PACKETS WERE COLLECTED, AND 10 PACKETS WERE UNOPENED PRODUCTS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19146877 ↗
• MalfunctionApr 19, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROTOMY GASTROINTESTINAL SURGERY, ON WOUND CLOSURE, THE THREAD BROKE. THE FIRST PACKET WAS DISCARDED, BUT SEVERAL SUTURES WERE CUT. THE SECOND PACKET WAS CUT OUT AS WELL, SO THE SUTURE ONE IN THE PACKET WAS CUT OFF WHEN IT WAS TOUCHED A LITTLE BIT, SO IT WAS KEPT.12 PACKETS WERE REPORTED, ONE PACKET THAT WAS DISPOSED OF AND NOT COLLECTED, ONE DEFECTIVE PRODUCT, ONLY TWO OF THE PACKETS WERE COLLECTED, AND 10 PACKETS WERE UNOPENED PRODUCTS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142727 ↗
• MalfunctionJan 31, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE SURGEON OPENED THE PACKET, THERE WERE ONLY THREE NEEDLE THREADS, ORIGINALLY FIVE PIECES. THERE WERE NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272553 ↗
• MalfunctionNov 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, WHEN THE PACKAGE WAS OPENED, THE NEEDLE AND SUTURE WERE DISCONNECTED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710399 ↗
• InjuryJan 20, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING ESOPHAGUS PROCEDURE, FIVE PIECES SHOULD BE INCLUDED, HOWEVER, ONLY FOUR PIECES WERE INCLUDED AT THE TIME OF NEEDLE COUNTING. THERE WERE FOUR PACKS, THE EVENT WAS NOTED WHEN RETURNING THE NEEDLE AT THE 17TH STITCH, AS THE SURGICAL FIELD WAS NOT CLOSED, BOTH INTRA-ABDOMINAL CT AND MRI EXAMINATION DID NOT FIND ANY NEEDLE OR THREAD. WHEN THE PACKAGE SPONGE PART WAS CHECKED, ONLY ONE PLACE WAS FOUND TO BE NO NEEDLE WAS PLACED. THE SURGEON WONDERED WHETHER THE SPONGE PART WOULD CLOSE AFTER TAKING THE NEEDLE OUT AND CHECKED IT FOR OVERNIGHT, IT WAS APPARENT THAT THE SPONGE PART HAD NOT BEEN PLACED WITH ANOTHER NEEDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 9607059 ↗
• InjuryJan 20, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING ESOPHAGUS PROCEDURE, FIVE PIECES SHOULD BE INCLUDED, HOWEVER, ONLY FOUR PIECES WERE INCLUDED AT THE TIME OF NEEDLE COUNTING. THERE WERE FOUR PACKS, THE EVENT WAS NOTED WHEN RETURNING THE NEEDLE AT THE 17TH STITCH, AS THE SURGICAL FIELD WAS NOT CLOSED, BOTH INTRA-ABDOMINAL CT AND MRI EXAMINATION DID NOT FIND ANY NEEDLE OR THREAD. WHEN THE PACKAGE SPONGE PART WAS CHECKED, ONLY ONE PLACE WAS FOUND TO BE NO NEEDLE WAS PLACED. THE SURGEON WONDERED WHETHER THE SPONGE PART WOULD CLOSE AFTER TAKING THE NEEDLE OUT AND CHECKED IT FOR OVERNIGHT, IT WAS APPARENT THAT THE SPONGE PART HAD NOT BEEN PLACED WITH ANOTHER NEEDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 9607046 ↗
• InjuryJan 20, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING ESOPHAGUS PROCEDURE, FIVE PIECES SHOULD BE INCLUDED, HOWEVER, ONLY FOUR PIECES WERE INCLUDED AT THE TIME OF NEEDLE COUNTING. THERE WERE FOUR PACKS, THE EVENT WAS NOTED WHEN RETURNING THE NEEDLE AT THE 17TH STITCH, AS THE SURGICAL FIELD WAS NOT CLOSED, BOTH INTRA-ABDOMINAL CT AND MRI EXAMINATION DID NOT FIND ANY NEEDLE OR THREAD. WHEN THE PACKAGE SPONGE PART WAS CHECKED, ONLY ONE PLACE WAS FOUND TO BE NO NEEDLE WAS PLACED. THE SURGEON WONDERED WHETHER THE SPONGE PART WOULD CLOSE AFTER TAKING THE NEEDLE OUT AND CHECKED IT FOR OVERNIGHT, IT WAS APPARENT THAT THE SPONGE PART HAD NOT BEEN PLACED WITH ANOTHER NEEDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 9607009 ↗
• MalfunctionNov 30, 2018Break; Break

  ACCORDING TO THE REPORTER, THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE THREAD BROKE EASILY WHEN THE DOCTOR WAS USING THE PRODUCT. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8119307 ↗
• MalfunctionSep 22, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING SUTURING OF FASCIA, THE TIP OF THE NEEDLE BROKE AND 2MM OF IT MIGHT HAVE FALLEN INTO THE PATIENT'S CAVITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. CURRENT PATIENT STATUS: UNKNOWN AS EXTENDED PROCESS NEEDED STILL.

  Patient problems: No Information

  MAUDE report 6887845 ↗

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