Polysorb CL-943Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521043596), received between Jul 14, 2025 and Aug 27, 2026 — classified as 8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Patient-Device Incompatibility

  It was reported that after a laparoscopic total hysterectomy plus abdominal drainage procedure where the devices were used in vaginal stump closure, during a follow-up check-up, the patient complained of vaginal pain. During gynecological examination, the physician found that the absorbable suture had not been absorbed, with local suture remnants visible and with mild tenderness. Three sutures were therefore removed. The patient's vaginal pain was relieved immediately after.

  Patient problems: Pain

  MAUDE report 50469560 ↗
• MalfunctionAug 27, 2026Patient-Device Incompatibility

  It was reported that after a laparoscopic total hysterectomy plus abdominal drainage procedure where the devices were used in vaginal stump closure, during a follow-up check-up, the patient complained of vaginal pain. During gynecological examination, the physician found that the absorbable suture had not been absorbed, with local suture remnants visible and with mild tenderness. Three sutures were therefore removed. The patient's vaginal pain was relieved immediately after.

  Patient problems: Pain

  MAUDE report 50469468 ↗
• MalfunctionJan 21, 2026Break

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, THE SUTURE BROKE TWICE WHILE CLOSING THE FAT LAYER, EVEN THOUGH THE INSTRUMENT DID NOT DAMAGE THE SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. SURGICAL TIME WAS EXTENDED BUT NOT MORE THAN 30 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 24131311 ↗
• MalfunctionJul 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BIRTH INJURIES PROCEDURE, AFTER PIERCING THE TISSUE THE NEEDLE DETACHED AT THE THREAD-NEEDLE JUNCTION DURING TIGHTENING. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. SURGICAL TIME WAS EXTENDED BUT NOT MORE THAN 30 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 22519715 ↗
• MalfunctionJul 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BIRTH INJURIES PROCEDURE, AFTER PIERCING THE TISSUE, THE NEEDLE DETACHED AT THE THREAD-NEEDLE JUNCTION DURING TIGHTENING. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. SURGICAL TIME WAS EXTENDED BUT NOT MORE THAN 30 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 22519683 ↗
• MalfunctionJul 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BIRTH PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD. THE SAME ISSUE OCCURRED ON THE OTHER TWO SUTURES FROM THE SAME BATCH. THE SURGICAL TIME WAS EXTENDED BY NOT MORE THAN 30 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 22496762 ↗
• MalfunctionJul 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BIRTH PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD. THE SAME ISSUE OCCURRED ON THE OTHER TWO SUTURES FROM THE SAME BATCH. THE SURGICAL TIME WAS EXTENDED BY NOT MORE THAN 30 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 22496761 ↗
• MalfunctionJul 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BIRTH PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD. THE SAME ISSUE OCCURRED ON THE OTHER TWO SUTURES FROM THE SAME BATCH. THE SURGICAL TIME WAS EXTENDED BY NOT MORE THAN 30 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 22496734 ↗

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