Polysorb CL-924Recalls & reported problems
Covidien LP · Braided Absorbable Suture · Class 2 · Implant
Quick summary
This Polysorb CL-924 is a Covidien braided absorbable suture used to close tissue. Across 66 reports, 62 malfunctions and 4 injuries are described, with no deaths. Most reports describe the needle coming apart from the thread during surgery, or the suture breaking — including several found already broken inside the package. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 65
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10884521043411), received between Jun 13, 2018 and Aug 14, 2026 — classified as 4 injuries, 61 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (39 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component39
- Break21
- Insufficient Device Problem Information2
- Patient-Device Incompatibility2
- Adverse Event Without Identified Device or Use Problem1
- Component Missing1
- Detachment Of Device Component1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- Insufficient Information9
- No Consequences Or Impact To Patient7
- No Known Impact Or Consequence To Patient5
- No Code Available3
- No Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Fluid Discharge1
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50251253 ↗MalfunctionAug 14, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50251195 ↗MalfunctionAug 14, 2026Detachment of Device or Device Component
According to the reporter, during a cesarean section, a size 0 absorbable suture was used to close the uterus. During suturing, the needle became detached from the suture. The suture was immediately replaced with a new one from a different manufacturer, and suturing was continued. The procedure was completed successfully with no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50251181 ↗MalfunctionAug 14, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50251109 ↗MalfunctionAug 14, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50251028 ↗MalfunctionJun 30, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, THE NEEDLE AND THREAD DETACHED WHILE TIGHTENING THE FIRST STITCH DURING UTERINE INCISION CLOSURE. THE SUTURE WAS IMMEDIATELY REPLACED BUT THE SECOND SUTURE ALSO HAD A NEEDLE DETACHED, AFTER WHICH A THIRD SUTURE WAS USED TO SUCCESSFULLY CONTINUE AND COMPLETE THE SUTURING. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25664984 ↗MalfunctionMay 7, 2026Break
ACCORDING TO THE REPORTER, WHEN THE PHYSICIAN WAS PREPARING TO SUTURE THE WOUND TISSUE OF THE PATIENT, SEVERAL SUTURES WERE FOUND TO BE BROKEN UPON OPENING THE PACKAGE. THE SUTURES WERE IMMEDIATELY REPLACED. NO ADVERSE IMPACT OCCURRED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114016 ↗MalfunctionFeb 3, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC GYNECOLOGICAL SURGERY, THE NEEDLE AND SUTURE DETACHED. THE DEVICE WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24250185 ↗MalfunctionJan 13, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING A GYNECOLOGICAL SURGERY, THE NEEDLE-THREAD DETACHED. AFTER REMOVING THE THREAD WHICH HAD NEEDLE AND THREAD DETACHMENT ISSUE, THE SCRUB NURSE QUICKLY REPLACED IT WITH ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24064292 ↗MalfunctionJan 5, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE SUTURING STEP OF A CESAREAN SECTION, WHILE CLOSING THE UTERUS WITH SUTURE, THE NEEDLE AND THREAD DETACHED. TEN DEFECTIVE DEVICES OF THE SAME PRODUCT AND LOT WERE INVOLVED IN THE SAME CASE. THE SUTURE WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23969226 ↗MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE SUTURING STEP OF A CESAREAN SECTION, WHILE CLOSING THE UTERUS WITH SUTURE, THE NEEDLE AND THREAD DETACHED. TEN DEFECTIVE DEVICES OF THE SAME PRODUCT AND LOT WERE INVOLVED IN THE SAME CASE. THE SUTURE WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23930993 ↗MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE SUTURING STEP OF A CESAREAN SECTION, WHILE CLOSING THE UTERUS WITH SUTURE, THE NEEDLE AND THREAD DETACHED. TEN DEFECTIVE DEVICES OF THE SAME PRODUCT AND LOT WERE INVOLVED IN THE SAME CASE. THE SUTURE WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23930990 ↗MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE SUTURING STEP OF A CESAREAN SECTION, WHILE CLOSING THE UTERUS WITH SUTURE, THE NEEDLE AND THREAD DETACHED. TEN DEFECTIVE DEVICES OF THE SAME PRODUCT AND LOT WERE INVOLVED IN THE SAME CASE. THE SUTURE WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23930989 ↗MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE SUTURING STEP OF A CESAREAN SECTION, WHILE CLOSING THE UTERUS WITH SUTURE, THE NEEDLE AND THREAD DETACHED. TEN DEFECTIVE DEVICES OF THE SAME PRODUCT AND LOT WERE INVOLVED IN THE SAME CASE. THE SUTURE WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23930983 ↗MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE SUTURING STEP OF A CESAREAN SECTION, WHILE CLOSING THE UTERUS WITH SUTURE, THE NEEDLE AND THREAD DETACHED. TEN DEFECTIVE DEVICES OF THE SAME PRODUCT AND LOT WERE INVOLVED IN THE SAME CASE. THE SUTURE WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23930980 ↗MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE SUTURING STEP OF A CESAREAN SECTION, WHILE CLOSING THE UTERUS WITH SUTURE, THE NEEDLE AND THREAD DETACHED. TEN DEFECTIVE DEVICES OF THE SAME PRODUCT AND LOT WERE INVOLVED IN THE SAME CASE. THE SUTURE WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23930940 ↗MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE SUTURING STEP OF A CESAREAN SECTION, WHILE CLOSING THE UTERUS WITH SUTURE, THE NEEDLE AND THREAD DETACHED. TEN DEFECTIVE DEVICES OF THE SAME PRODUCT AND LOT WERE INVOLVED IN THE SAME CASE. THE SUTURE WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23930939 ↗MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE SUTURING STEP OF A CESAREAN SECTION, WHILE CLOSING THE UTERUS WITH SUTURE, THE NEEDLE AND THREAD DETACHED. TEN DEFECTIVE DEVICES OF THE SAME PRODUCT AND LOT WERE INVOLVED IN THE SAME CASE. THE SUTURE WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23930927 ↗MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE SUTURING STEP OF A CESAREAN SECTION, WHILE CLOSING THE UTERUS WITH SUTURE, THE NEEDLE AND THREAD DETACHED. TEN DEFECTIVE DEVICES OF THE SAME PRODUCT AND LOT WERE INVOLVED IN THE SAME CASE. THE SUTURE WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23930753 ↗MalfunctionNov 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LOWER SEGMENT CESAREAN SECTION UNDER SPINAL ANESTHESIA, THE NEEDLE-THREAD DETACHED WHILE USING HIGH-VALUE CONSUMABLES (NEEDLE AND SUTURE COMBINED) TO CLOSE THE WOUND. THE NEEDLE AND SUTURE WERE IMMEDIATELY REPLACED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23667639 ↗MalfunctionNov 27, 2025Break; Break
ACCORDING TO THE REPORTER, DURING SURGERY, THE SUTURE BROKE AND COULD NOT BE USED PROPERLY. A NEW SUTURE WAS IMMEDIATELY REPLACED, WHICH CAUSED A DELAY IN THE SMOOTH PROGRESS OF THE OPERATION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23664360 ↗MalfunctionNov 14, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A SYNDESMOTIC LIGAMENT REPAIR, WHILE SUTURING, THE SUTURE SUDDENLY BROKE UNDER MILD TENSION. THE BROKEN SUTURE WAS IMMEDIATELY REMOVED AND REPLACED WITH A NEW ONE TO COMPLETE THE OPERATION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23554228 ↗MalfunctionSep 4, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, THREE DAYS POST-OPERATIVELY TO POSTERIOR LUMBAR LAMINECTOMY DECOMPRESSION, DURING WARD ROUNDS, THERE WAS FLUID LEAKAGE OBSERVED AT THE PATIENT'S SURGICAL WOUND. AFTER REINFORCING THE DRESSING CHANGES, THE FLUID LEAKAGE REDUCED.
Patient problems: Fluid Discharge
MAUDE report 22965627 ↗MalfunctionJul 25, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING A PROCEDURE TWO NEEDLES WERE FOUND STACKED TOGETHER IN ONE ENVELOPE, RESULTING IN ONE EXTRA NEEDLE BEING PRESENT. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22606394 ↗MalfunctionJul 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING THE SUTURING OF THE CERVICAL STUMP, A SUDDEN BREAKAGE OCCURRED BETWEEN THE NEEDLE TAIL AND THE SUTURE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22587445 ↗
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 · TerminatedPolysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
- Z-2541-2017 · May 3, 2017 · TerminatedSutures. 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
Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices
- Coated VICRYL VCP433HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death1,093 reports
- Polysorb CL-915Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID503 reports
- Coated VICRYL VCP493HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID435 reports
- V-Loc 180 VLOCL0316Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall376 reports
- Coated VICRYL VCP345HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death405 reports
- V-Loc 180 VLOCL0604Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall328 reports
- V-Loc 180 VLOCA008LCovidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall294 reports
- V-Loc 180 VLOCL0326Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID330 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.