Polysorb CL-905Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10884521042957), received between Jul 24, 2017 and Sep 6, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION UNDER COMBINED SPINAL-EPIDURAL ANESTHESIA, AFTER THE NEWBORN WAS DELIVERED, THE DOCTOR USED SYNTHETIC ABSORBABLE SUTURE 905 TO CLOSE THE UTERINE INCISION. A FEW STITCHES INTO THE SUTURING PROCESS, THE SUTURE BROKE, LEADING TO INCREASED BLEEDING FROM THE INCISION. THE DOCTOR IMMEDIATELY REQUESTED A REPLACEMENT SUTURE OF THE SAME MODEL TO CONTINUE THE SUTURING. THE SURGERY THEN PROCEEDED SMOOTHLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22987230 ↗
• MalfunctionJul 3, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A PROCEDURE, WHILE SUTURING, THE NEEDLE WAS BROKEN BUT IT DID NOT FALL INTO THE PATIENT'S CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394612 ↗
• MalfunctionJul 3, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE NEEDLE WAS BROKEN. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 22394124 ↗
• MalfunctionJun 17, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC CAESAREAN SECTION, IN SUTURING THE UTERUS WHILE EMPLOYING A CONTINUOUS SUTURE TECHNIQUE, THE NEEDLE AND THREAD BROKE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22224420 ↗
• MalfunctionNov 25, 2024Break; Break

  ACCORDING TO THE REPORTER DURING A CESAREAN SECTION, WHEN THE DOCTOR WAS SUTURING THE UTERUS, WHILE SUTURING HALFWAY THE THREAD BROKE WHEN PULLED. WHICH PROLONGED THE SURGERY TIME OF SUTURING OF THE UTERUS BY MORE THAN 30 MINUTES AND INCREASED THE AMOUNT OF BLEEDING. THE DOCTOR IMMEDIATELY REPLACED IT WITH THE NEW SUTURE FOR SUBSEQUENT SUTURING OPERATIONS. THE OPERATION WAS SUCCESSFUL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20770952 ↗
• MalfunctionJul 1, 2024Adverse 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, POST OPERATIVELY, THERE WERE SOME SEROMA.

  Patient problems: Seroma

  MAUDE report 19643876 ↗
• MalfunctionOct 9, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC UTERINE MYOMECTOMY, BROAD LIGAMENT MYOMECTOMY, BILATERAL UTERINE ARTERY LIGATION, AND PELVIC ADHESION SEPARATION PROCEDURE, AT THE TIME OF PULLING AND KNOTTING THE SUTURE WHILE SUTURING THE MYOMETRIUM, THE SUTURE BROKE MULTIPLE TIMES. THE SURGEON USED A NEW SUTURE TO RESOLVE THE ISSUE. THIS LED TO 10 MINUTES PROLONGED SURGICAL TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17901475 ↗
• MalfunctionMar 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, UPON OPENING THE SUTURE PACKET, THE NURSE NOTICED THAT THE THREAD WAS NOT ATTACHED TO THE NEEDLE. ANOTHER SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16611824 ↗
• MalfunctionJan 10, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A MYOMECTOMY, THE SUTURE THREAD BROKE WHEN THE SURGEON PULLED THE SUTURE. AFTER TYING THE KNOT, THE SURGEON CONTINUED TO USE THE SUTURE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16133243 ↗
• MalfunctionJan 4, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC UTERINE MYOMA EXCLUSION, WHEN THE DEVICE WAS APPLIED TO THE WOUND, THE THREAD HAD BROKE. AFTER TYING THE KNOT, RE-SUTURING WAS PERFORMED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16098797 ↗
• MalfunctionFeb 11, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, THE THREAD OF THE DEVICE IS BROKEN WHEN THE SURGEON IS PERFORMING A CONTINUOUS RUNNING STITCH. A NEW SET IS USED TO CONTINUE THE PROCEDURE.

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

  MAUDE report 13517621 ↗
• MalfunctionApr 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, UPON CLAMPING THE SUTURE INTO THE NEEDLE HOLDER, THE SURGEON NOTICED THAT THE SUTURE DETACHED FROM THE NEEDLE. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617021 ↗
• MalfunctionMar 31, 2021Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC REMOVAL OF RIGHT OVARIAN TUMOR, REMOVAL OF THE RIGHT MESANGIAL CYST, UTERINE FIBROIDS REMOVAL, ADHESIOLYSIS, AND DRAINAGE. AFTER THE TUMOR WAS REMOVED, WHEN THE DOCTOR WAS ABOUT TO SUTURE THE WOUND, IT WAS FOUND THAT THE SUTURE NEAR THE NEEDLE WAS BROKEN. THE PRODUCT WAS NOT USED ON PATIENT. ANOTHER SUTURE OF THE SAME BRAND WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11600218 ↗
• MalfunctionOct 12, 2020Break; Break

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, WHEN SUTURE WAS BEING TESTED, IT BROKE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10667246 ↗
• MalfunctionOct 7, 2020Break; Break

  ACCORDING TO THE REPORTER, A MINUTE INTO THE INGUINAL HERNIA REPAIR, FOUR SUTURE THREADS BROKE. DEVICES WERE NOT USED IN PATIENT. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10640958 ↗
• MalfunctionAug 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE SUTURE WAS BEING TAKEN OUT OF THE PACKAGE INTRA-OPERATIVELY, THE NEEDLE SNAPPED OFF WHERE THE SUTURE MEETS THE NEEDLE. THE SUTURE WAS NOT USED ON PATIENT. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10457530 ↗
• MalfunctionAug 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, UPON OPENING THE PACKAGE, IT WAS FOUND THAT THE DEVICE SUTURE WAS BROKEN IN WHICH THE NEEDLE WAS PHYSICALLY DETACHED FROM IT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10371139 ↗
• MalfunctionFeb 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, DURING A WHIPPLE PROCEDURE, THE SURGEON NOTICED THAT THE SUTURE THAT HAD BEEN USED JUST 3 WEEKS AGO HAD ALREADY BEGAN TO ABSORB. THE SURGEON FELT LIKE THE SUTURE WAS ABSORBING PREMATURELY. SURGEON CONTINUED THE CASE BY USING OTHER SUTURE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9666867 ↗
• MalfunctionJun 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC EXTRAFASCIAL HYSTERECTOMY PROCEDURE, WHEN THE DOCTOR OPENED A STERILIZATION PACKAGE OF SYNTHETIC ABSORBABLE SURGICAL SUTURES, IT WAS NOTICED THAT THE NEEDLE AND THE SUTURE WERE SEPARATED. THEY REPLACED A PACKAGE OF SUTURE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7598413 ↗
• MalfunctionAug 6, 2017Break; Break

  ACCORDING TO THE REPORTER, THE THREAD BROKE MAKING THE SUTURE LINE INCOMPLETE. IN ORDER TO RESOLVE THE ISSUE, THE SURGEON RE-SUTURED THE SUTURE LINE. THERE WAS NO PATIENT INJURY INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6769916 ↗
• MalfunctionAug 3, 2017Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY IN A CESAREAN SECTION THERE WAS A MATERNAL BLEEDING WHEN THE FETUS WAS REMOVED DUE TO BROKEN THREAD. TO COMPLETE THE CASE AND RESOLVED THE ISSUE THEY RE-STITCHED. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: Blood Loss; No Known Impact Or Consequence To Patient

  MAUDE report 6763775 ↗
• MalfunctionJul 24, 2017Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING A CESAREAN SECTION. DURING SUTURING, THE THREAD BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6735825 ↗

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