Polysorb CL-945Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521043619), received between Sep 3, 2019 and Jul 8, 2026 — classified as 2 injuries, 13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CEPHALIC DUODENO-PANCREATICECTOMY PROCEDURE, WHILE SUTURING OR WHILE PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE WHEN THE SURGEON TIED THE KNOT. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE FROM DIFFERENT COMPANY WAS USED TO RESOLVE THE ISSUE. IT OCCURRED ON SIX SUTURES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25743818 ↗
• MalfunctionJun 19, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CEPHALIC DUODENO-PANCREATICECTOMY PROCEDURE, WHILE SUTURING OR WHILE PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE WHEN THE SURGEON TIED THE KNOT. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE FROM DIFFERENT COMPANY WAS USED TO RESOLVE THE ISSUE. IT OCCURRED ON SIX SUTURES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25567994 ↗
• MalfunctionJun 19, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CEPHALIC DUODENO-PANCREATICECTOMY PROCEDURE, WHILE SUTURING OR WHILE PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE WHEN THE SURGEON TIED THE KNOT. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE FROM DIFFERENT COMPANY WAS USED TO RESOLVE THE ISSUE. IT OCCURRED ON SIX SUTURES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25567980 ↗
• MalfunctionMar 18, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A CESAREAN SECTION, WHEN CLOSING THE UTERUS, THE NEEDLE DETACHED FROM THE SUTURE THREAD. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24635671 ↗
• MalfunctionMar 18, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A CESAREAN SECTION, WHEN CLOSING THE UTERUS, THE NEEDLE DETACHED FROM THE SUTURE THREAD. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24635648 ↗
• MalfunctionDec 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE CLOSING THE UTERUS, THE NEEDLE DETACHED ON TWO DIFFERENT SUTURES FROM THE SAME BATCH. A NEW BOX OF SUTURES WITH A DIFFERENT BATCH NUMBER WAS SUBSEQUENTLY USED, AND THE PROCEDURE CONTINUED SMOOTHLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892377 ↗
• MalfunctionDec 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE CLOSING THE UTERUS, THE NEEDLE DETACHED ON TWO DIFFERENT SUTURES FROM THE SAME BATCH. A NEW BOX OF SUTURES WITH A DIFFERENT BATCH NUMBER WAS SUBSEQUENTLY USED, AND THE PROCEDURE CONTINUED SMOOTHLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892364 ↗
• MalfunctionJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SUTURING, THE NEEDLE DETACHED FROM THE SUTURE AND REMAINED BURIED IN THE UTERUS. THE NEEDLE WAS RETRIEVED BY SEARCHING MANUALLY BY TOUCH. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THE EVENT RESULTED IN EXTENDED SURGICAL TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563497 ↗
• MalfunctionDec 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CAESARIAN SECTION PROCEDURE, INVOLVING THE CL-945 POLYSORB SUTURE, A NEEDLE DETACHMENT FROM THE SUTURE OCCURRED. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894765 ↗
• InjurySep 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGICAL UTERINE PROCEDURE, IN SUTURING THE UTERUS (CONTINUOUS SUTURE TECHNIQUE), THE NEEDLE BROKE AND FALL INTO THE PATIENT¿S CAVITY. TO RESOLVE THE ISSUE, X-RAY WAS PERFORMED, AND THE NEEDLE WAS RETRIEVED AFTER SEARCHING FOR MORE THAN TEN MINUTES. ANOTHER SUTURE WAS THEN USED TO COMPLETE THE SURGERY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 20241752 ↗
• MalfunctionAug 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE DEVICE WAS OPENED, THE THREAD WAS SEPARATED FROM THE NEEDLE. AN ADDITIONAL SUTURE WAS USED WITHOUT A PROBLEM. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259995 ↗
• InjuryMay 19, 2022Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, WHILE CLOSING THE UTERUS IN AN OPEN CAESAREAN SECTION, THE NEEDLE BROKE. PATIENT HAD TO UNDERGO IONIZING RADIATION EXPOSURE FOR 17 MINUTES AND SURGICAL TIME WAS EXTENDED BY AN HOUR (UNDER ANESTHESIA). THE BROKEN NEEDLE WAS RETRIEVED WITH THE USE OF AN IMAGE INTENSIFIER TO TAKE PICTURES TO VISUALIZE THE LOCATION OF THE BROKEN PIECE. SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque; Unintended Radiation Exposure

  MAUDE report 14435721 ↗
• MalfunctionSep 9, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING SPINE SURGERY, THE NEEDLE BROKE BEFORE TO TIGHT A KNOT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information; No Information

  MAUDE report 10506380 ↗
• MalfunctionJun 1, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CESAREAN PROCEDURE, THE SUTURE'S NEEDLE WAS BROKEN. THE NEEDLE FELL INTO THE PATIENT'S CAVITY AND WAS WITHDRAWN USING A NEEDLE HOLDER. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10104065 ↗
• MalfunctionSep 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR OPEN LAPAROTOMY, UPON OPENING THE DEVICE, IT WAS FOUND THAT THE NEEDLE WERE SEPARATED FROM THE SUTURE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8958332 ↗

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