Polysorb CLT-957Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521044791), received between Aug 12, 2022 and Apr 2, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC MYOMECTOMY, WHILE IN THE UTERUS, THE MULTIPLE NEEDLES AND THREAD WERE EITHER BROKEN UPON OPENING OR FRACTURED DURING THE PROCEDURE. ANOTHER DEVICE FROM ANOTHER LOT NUMBER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767671 ↗
• MalfunctionMar 23, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC MYOMECTOMY, WHILE IN THE UTERUS, THE MULTIPLE NEEDLES AND THREAD WERE EITHER BROKEN UPON OPENING OR FRACTURED DURING THE PROCEDURE. ANOTHER DEVICE FROM ANOTHER LOT NUMBER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24659472 ↗
• MalfunctionFeb 2, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC MYOMECTOMY, WHILE IN THE UTERUS, THE MULTIPLE NEEDLES AND THREAD WERE EITHER BROKEN UPON OPENING OR FRACTURED DURING THE PROCEDURE. ANOTHER DEVICE FROM ANOTHER LOT NUMBER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242719 ↗
• MalfunctionJun 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, DURING THE UTERINE SUTURING PROCESS, THE NEEDLE AND SUTURE WERE DETACHED, WHICH PREVENTED THE SURGERY FROM PROCEEDING SMOOTHLY. THE SUTURE WAS IMMEDIATELY REPLACED WITH A NEW SUTURE TO FIX THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145972 ↗
• MalfunctionMar 27, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, WHEN THE SURGEON FINISHED SUTURING THE UTERUS, THE THREAD BROKE DURING THE KNOTTING PROCESS, CAUSING THE TIME TO BE EXTENDED BY 15 MINUTES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710736 ↗
• MalfunctionNov 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, BEFORE USE, THE NEEDLE DETACHED FROM THE THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18162648 ↗
• MalfunctionNov 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO CAESARIAN SECTION AND UTERUS SUTURING, THE NEEDLE DETACHED FROM THE THREAD AND COULD NOT BE USED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18151120 ↗
• MalfunctionNov 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION PROCEDURE, BEFORE USING THE DEVICE FOR UTERUS SUTURING, THERE WAS AN ABNORMAL DETACHMENT OF THE NEEDLE AS A WHOLE TO THE SUTURE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144401 ↗
• MalfunctionNov 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, BEFORE USE, THE THREAD DETACHED FROM THE NEEDLE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144360 ↗
• MalfunctionNov 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE NEEDLE AND THREAD WERE DETACHED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142882 ↗
• MalfunctionAug 21, 2023Break; Break

  ACCORDING TO THE REPORTER, THE THREAD BROKE.

  Patient problems: Insufficient Information

  MAUDE report 17590296 ↗
• MalfunctionAug 18, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN GYNECOLOGICAL MYOMECTOMY, WHEN STITCHING THE UTERUS. THE THREAD OF FOUR SUTURES BROKE. A COMPETITOR SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17580768 ↗
• MalfunctionAug 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, WHILE SUTURING, THE NEEDLE AND THREAD WERE ACCIDENTALLY SEPARATED. TO ADDRESS THE ISSUE, THE SURGEON TIED THE KNOT FIRST AND THEN REPLACED THE SEPARATED NEEDLE AND THREAD WITH A NEW SUTURE PACK. DESPITE THE INCIDENT, THE SUTURING PROCESS CONTINUED SMOOTHLY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 17484703 ↗
• MalfunctionJul 25, 2023Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE THREAD WAS BROKEN WHEN THE PACKS WERE OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391110 ↗
• MalfunctionMar 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE TISSUE SUTURING PROCESS OF LAPAROSCOPIC SURGERY, THE NEEDLE AND THREAD WERE SEPARATED. NEW SUTURES WERE USED TO RESOLVE THE ISSUE.

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

  MAUDE report 16660095 ↗
• MalfunctionMar 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, WHEN SUTURING, THE NEEDLE AND SUTURE WERE DETACHED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16619810 ↗
• MalfunctionMar 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC OBSTETRIC AND GYNECOLOGICAL PROCEDURE, WHEN THE PACKAGE WAS OPENED, THE SUTURE AND NEEDLE WERE DETACHED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16619710 ↗
• MalfunctionAug 12, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING CESAREAN SECTION, WHEN THE DOCTOR SUTURED THE UTERUS, THE SYNTHETIC ABSORBABLE SURGICAL SUTURE BROKE CONTINUOUSLY. A NEW SUTURE PACK WAS RE-OPENED TO COMPLETE THE SUTURING AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15220782 ↗

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