Polysorb CL-925Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 10884521043428), received between Apr 25, 2018 and Aug 27, 2026 — classified as 8 injuries, 90 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (80 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 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Patient-Device Incompatibility

  It was reported that post-operatively, the patient underwent redo surgery due to surgical-site infection associated with the suture.

  Patient problems: Tissue Breakdown; Unspecified Infection

  MAUDE report 50467037 ↗
• InjuryAug 27, 2026Patient-Device Incompatibility

  It was reported that post-operatively, the patient underwent redo surgery due to surgical-site infection associated with the suture.

  Patient problems: Tissue Breakdown; Unspecified Infection

  MAUDE report 50467031 ↗
• InjuryAug 26, 2026Patient-Device Incompatibility

  Patient problems: Tissue Breakdown; Unspecified Infection

  MAUDE report 50464419 ↗
• InjuryAug 26, 2026Patient-Device Incompatibility

  It was reported that post-operatively, the patient underwent redo surgery due to surgical-site infection associated with the suture.

  Patient problems: Tissue Breakdown; Unspecified Infection

  MAUDE report 50464409 ↗
• InjuryAug 26, 2026Patient-Device Incompatibility

  Patient problems: Tissue Breakdown; Unspecified Infection

  MAUDE report 50464375 ↗
• InjuryAug 26, 2026Patient-Device Incompatibility

  It was reported that post-operatively, the patient underwent redo surgery due to surgical-site infection associated with the suture.

  Patient problems: Tissue Breakdown; Unspecified Infection

  MAUDE report 50464359 ↗
• InjuryAug 26, 2026Patient-Device Incompatibility

  It was reported that post-operatively, the patient underwent redo surgery due to surgical-site infection associated with the suture.

  Patient problems: Tissue Breakdown; Unspecified Infection

  MAUDE report 50459127 ↗
• InjuryAug 26, 2026Unraveled Material

  It was reported that 15 days postoperatively upon patient readmission, the patient experienced wound dehiscence and surgical-site infection (SSI). The patient was readmitted to the hospital for approximately 1 week and admitted to the intensive care unit (ICU). Additional redo surgery was performed for the surgical-site infection and failed suture line.

  Patient problems: Tissue Breakdown; Wound Dehiscence

  MAUDE report 50456058 ↗
• MalfunctionSep 5, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE MAKING THE RESPECTIVE STITCHES, PULLING TO TIGHTEN THE DEVICE CAUSED THE SUTURE STRAND TO BREAK, FORCING THE SURGEON TO DISMANTLE THE SUTURE AND START AGAIN. A NEW SUTURE HAD TO BE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976889 ↗
• MalfunctionAug 26, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE THREAD AND NEEDLE WAS CUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894131 ↗
• MalfunctionMay 12, 2025Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING C-SECTION WHILE CLOSURE OF UTERUS, THE NEEDLE BENT AND DETACHED FROM THE SUTURE WHILE PREPARING AFTER A PATIENT INCISION. A NEW STRAND WAS USED TO RESOLVE THE ISSUE. THERE WAS MORE THAN ONE DEFECTIVE DEVICE INVOLVED, ALL FROM THE SAME PRODUCT ID AND LOT NUMBER. NO ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22007153 ↗
• MalfunctionMay 12, 2025Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING C-SECTION WHILE CLOSURE OF UTERUS, THE NEEDLE BENT AND DETACHED FROM THE SUTURE WHILE PREPARING AFTER A PATIENT INCISION. A NEW STRAND WAS USED TO RESOLVE THE ISSUE. THERE WAS MORE THAN ONE DEFECTIVE DEVICE INVOLVED, ALL FROM THE SAME PRODUCT ID AND LOT NUMBER. NO ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22007152 ↗
• MalfunctionMar 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE HYSTERECTOMY, WHILE SEWING THE UTERUS WITH THE SUTURE, THE NEEDLE BROKE AT THE NEEDLE-THREAD CONNECTION. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. ANOTHER SEAM WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21681429 ↗
• MalfunctionFeb 18, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE. IT WAS NOTED THAT THERE WERE FOUR SUTURES USED IN THE PROCEDURE. AS A RESOLUTION, THE SUTURE WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405750 ↗
• MalfunctionFeb 18, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING PROCEDURE, WHILE SUTURING, THE SUTURE BROKE. IT WAS NOTED THAT THERE WERE FOUR SUTURE USED IN THE PROCEDURE. AS A RESOLUTION THE SUTURE WERE REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402849 ↗
• MalfunctionFeb 18, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING PROCEDURE, WHILE SUTURING, THE SUTURE BROKE. IT WAS NOTED THAT THERE WERE FOUR SUTURE USED IN THE PROCEDURE. AS A RESOLUTION THE SUTURE WERE REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401630 ↗
• MalfunctionFeb 18, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING PROCEDURE, WHILE SUTURING, THE SUTURE BROKE. IT WAS NOTED THAT THERE WERE FOUR SUTURES USED IN THE PROCEDURE. AS A RESOLUTION THE SUTURE WERE REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401531 ↗
• MalfunctionJan 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESAREAN PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE WITHOUT MAKING ANY EFFORT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21258360 ↗
• MalfunctionJan 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESAREAN PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE WITHOUT MAKING ANY EFFORT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21258235 ↗
• MalfunctionJan 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESAREAN PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE WITHOUT MAKING ANY EFFORT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21258031 ↗
• MalfunctionJan 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING, THE NEEDLE DETACHED FROM THE THREAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21175969 ↗
• MalfunctionJan 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A PROCEDURE, WHILE SUTURING THERE WAS NEEDLE DETACHMENT.

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

  MAUDE report 21093485 ↗
• MalfunctionDec 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESAREAN PROCEDURE, WHILE SUTURING, THE NEEDLE DETACHED. THIS ISSUE OCCURRED ON TWO DEVICES. TO RESOLVE THE ISSUE, ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880799 ↗
• MalfunctionDec 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, DURING A CAESARIAN SECTION, THE THREE NEEDLES WERE DETACHED FROM THEIR THREAD. THE ISSUE OCCURRED IN MORE THAN ONE SUTURE. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819019 ↗
• MalfunctionNov 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE DETACHED FROM THEIR THREAD. THE ISSUE OCCURRED IN MORE THAN ONE SUTURE. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798388 ↗

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