Polysorb CL-915Recalls & reported problems

Summary

The FDA's MAUDE database contains 503 adverse event reports that list this exact device (DI 10884521043336), received between Aug 25, 2016 and Sep 23, 2026 — classified as 20 injuries, 483 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (324 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 503 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break; Difficult to Open or Remove Packaging Material

  It was reported that, preoperatively, the suture broke while being removed from the retainer and prepared. There was also difficulty removing the suture from the retainer/packaging. More than one defective suture was involved. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871542 ↗
• MalfunctionSep 23, 2026Break; Difficult to Open or Remove Packaging Material

  It was reported that, preoperatively, the suture broke while being removed from the retainer and prepared. There was also difficulty removing the suture from the retainer/packaging. More than one defective suture was involved. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871510 ↗
• MalfunctionSep 23, 2026Break

  It was reported that two consecutive sutures of the same model broke during suturing. Use was stopped immediately and replaced with a new product. This extended the time required to complete the surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868544 ↗
• MalfunctionSep 23, 2026Break

  It was reported that two consecutive sutures of the same model broke during suturing. Use was stopped immediately and replaced with a new product. This extended the time required to complete the surgery.

  Patient problems: Insufficient Information

  MAUDE report 50868459 ↗
• MalfunctionSep 22, 2026Detachment of Device or Device Component

  It was reported that pre-operatively, after opening the package, a light touch caused the needle and thread to detach. More than one device was involved. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854088 ↗
• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50574060 ↗
• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50573943 ↗
• MalfunctionAug 24, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50417954 ↗
• MalfunctionAug 16, 2026Detachment of Device or Device Component

  It was reported that during a cesarean section involving laparoscopic and open procedures, the needle detached on two sutures during continuous uterine suturing. A new suture was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50264879 ↗
• MalfunctionJun 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CAESAREAN SECTION OPEN PROCEDURE, AT THE START OF SUTURING USING A CONTINUOUS SUTURING TECHNIQUE, AFTER ONE TO TWO STITCHES, SIX NEEDLES AND SUTURE THREADS DETACHED. ANOTHER SUTURE WAS REPLACED TO COMPLETE THE CASE 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 25627504 ↗
• MalfunctionJun 12, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SUTURE WAS USED FOR WOUND CLOSURE, AFTER OPENING AND USING IT, THE NEEDLE AND THREAD DETACHED AFTER THREE STITCHES AND COULD NOT BE USED, DELAYING THE PROGRESS OF THE SURGERY. THE SUTURE WAS REPLACED WITH A NEW ONE TO CONTINUE SUTURING.

  Patient problems: Insufficient Information

  MAUDE report 25489892 ↗
• MalfunctionJun 11, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING AN OPEN CESAREAN SECTION, WHEN BEGINNING TO STITCH, ONE OR TWO STITCHES HAD BEEN APPLIED THEN BOTH NEEDLE AND THREAD OF SIX SUTURES BROKE. ANOTHER SUTURE WAS USED INSTEAD FOR STITCHING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25467093 ↗
• MalfunctionJun 11, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING AN OPEN CESAREAN SECTION, WHEN BEGINNING TO STITCH, ONE OR TWO STITCHES HAD BEEN APPLIED THEN BOTH NEEDLE AND THREAD OF SIX SUTURES BROKE. ANOTHER SUTURE WAS USED INSTEAD FOR STITCHING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25467067 ↗
• MalfunctionJun 11, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING AN OPEN CESAREAN SECTION, WHEN BEGINNING TO STITCH, ONE OR TWO STITCHES HAD BEEN APPLIED THEN BOTH NEEDLE AND THREAD OF SIX SUTURES BROKE. ANOTHER SUTURE WAS USED INSTEAD FOR STITCHING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25467032 ↗
• MalfunctionJun 11, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING AN OPEN CESAREAN SECTION, WHEN BEGINNING TO STITCH, ONE OR TWO STITCHES HAD BEEN APPLIED THEN BOTH NEEDLE AND THREAD OF SIX SUTURES BROKE. ANOTHER SUTURE WAS USED INSTEAD FOR STITCHING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25466963 ↗
• MalfunctionJun 10, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN CESAREAN SECTION, WHEN BEGINNING TO STITCH, ONE OR TWO STITCHES HAD BEEN APPLIED THEN BOTH NEEDLE AND THREAD OF SIX SUTURES BROKE. ANOTHER SUTURE WAS USED INSTEAD FOR STITCHING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25459435 ↗
• MalfunctionJun 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CAESAREAN SECTION OPEN PROCEDURE, AT THE START OF SUTURING USING A CONTINUOUS SUTURING TECHNIQUE, AFTER ONE TO TWO STITCHES, TWO NEEDLES AND SUTURE THREADS DETACHED. ANOTHER SUTURE WAS REPLACED TO COMPLETE THE CASE 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 25456733 ↗
• MalfunctionJun 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CAESAREAN SECTION OPEN PROCEDURE, AT THE START OF SUTURING USING A CONTINUOUS SUTURING TECHNIQUE, AFTER ONE TO TWO STITCHES, TWO NEEDLES AND SUTURE THREADS DETACHED. ANOTHER SUTURE WAS REPLACED TO COMPLETE THE CASE 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 25456691 ↗
• MalfunctionJun 9, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER TWO OR THREE STITCHES WERE PLACED, THE NEEDLE AND THREAD DETACHED AND COULD NO LONGER BE USED. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25449557 ↗
• MalfunctionJun 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CAESAREAN SECTION OPEN PROCEDURE, AT THE START OF SUTURING USING A CONTINUOUS SUTURING TECHNIQUE, AFTER ONE TO TWO STITCHES, TWO NEEDLES AND SUTURE THREADS DETACHED. ANOTHER SUTURE WAS REPLACED TO COMPLETE THE CASE 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 25449337 ↗
• MalfunctionJun 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CAESAREAN SECTION OPEN PROCEDURE, AT THE START OF SUTURING USING A CONTINUOUS SUTURING TECHNIQUE, AFTER ONE TO TWO STITCHES, TWO NEEDLES AND SUTURE THREADS DETACHED. ANOTHER SUTURE WAS REPLACED TO COMPLETE THE CASE 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 25449303 ↗
• MalfunctionJun 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS NEEDLE DETACHMENT. NO DEVICE COMPONENT FELL INTO THE PATIENT CAVITY. AN 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 25401266 ↗
• MalfunctionJun 4, 2026Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A MYOMECTOMY PROCEDURE, THE NEEDLE BENT. THIS OCCURRED REPEATEDLY ACROSS 34 SUTURES. ADDITIONALLY, OUT OF THE 32 SUTURES, SIX SUTURES ALSO HAD THEIR THREAD DETACHED FROM THE SWAGE POINT, WHILE SUTURING OR WHILE PREPARING THE SUTURE AFTER THE PATIENT'S INCISION; THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. IT WAS REPORTED THAT THE SURGERY WAS INTERRUPTED MULTIPLE TIMES DUE TO THE ISSUES, AND THAT AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25395072 ↗
• MalfunctionJun 4, 2026Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A MYOMECTOMY PROCEDURE, THE NEEDLE BENT. THIS OCCURRED REPEATEDLY ACROSS 32 SUTURES. ADDITIONALLY, OUT OF THE 32 SUTURES, SIX SUTURES ALSO HAD THEIR THREAD DETACHED FROM THE SWAGE POINT, WHILE SUTURING OR WHILE PREPARING THE SUTURE AFTER THE PATIENT'S INCISION; THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. IT WAS REPORTED THAT THE SURGERY WAS INTERRUPTED MULTIPLE TIMES DUE TO THE ISSUES, AND THAT AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394998 ↗
• MalfunctionMay 14, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE CESAREAN SECTION, THE SUTURE WAS USED FOR SURGICAL WOUND CLOSURE. BEFORE SURGERY, THE SUTURE PACKAGING AND THE APPEARANCE OF THE NEEDLE AND SUTURE WERE ROUTINELY INSPECTED AND NO ABNORMALITIES WERE FOUND. DURING NORMAL SUTURING, WHEN THE PHYSICIAN APPLIED ROUTINE TRACTION TO THE SUTURE, THE NEEDLE SEPARATED FROM THE SUTURE WITHOUT ANY ADDITIONAL FORCE BEING APPLIED. THE PHYSICIAN CONFIRMED THAT THE SUTURE COULD NO LONGER BE USED AND HAD TO INTERRUPT THE CURRENT SUTURING OPERATION. A NEW BACKUP SUTURE OF THE SAME MODEL WAS USED TO CONTINUE AND COMPLETE THE SUTURING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25177024 ↗

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