Polysorb CL-922Recalls & reported problems
Covidien LP · Braided Absorbable Suture · Class 2 · Implant
Quick summary
This Polysorb CL-922 braided absorbable suture (Covidien LP) closes wounds. Reports mostly describe needles or thread detaching or breaking, sometimes before use, with a few mentions of abnormal color. Of 40 reports, there were no deaths, 10 injuries, and 30 malfunctions; injuries included pain, impaired healing, and tissue injury. No recalls name this device. Reports rose sharply, from 4 in the prior 12 months to 18 in the most recent 12 months.
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
- 40
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10884521043398), received between May 10, 2018 and Sep 23, 2026 — classified as 10 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 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 Component17
- Patient-Device Incompatibility12
- Break9
- Device Operates Differently Than Expected2
- Adverse Event Without Identified Device or Use Problem1
- Device Slipped1
- Human-Device Interface Problem1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Pain5
- No Code Available4
- Impaired Healing3
- Insufficient Information3
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient3
- Unspecified Tissue Injury3
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50863093 ↗MalfunctionAug 24, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50418255 ↗MalfunctionJul 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50068769 ↗MalfunctionJul 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50068747 ↗MalfunctionJul 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50068729 ↗MalfunctionJul 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50068686 ↗MalfunctionJul 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50068629 ↗MalfunctionMay 6, 2026Break; Product Quality Problem; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE BEFORE USING ON THE PATIENT, UPON OPENING THE PACKAGE, THE SCRUB NURSE FOUND THAT THE NEEDLE AND THREAD WERE SEPARATED, THE COLOR WAS ABNORMAL, AND THE SUTURE BROKE EASILY UPON SLIGHT TRACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25098006 ↗MalfunctionFeb 27, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VAGINAL LACERATION REPAIR USING THE SUTURE, THE NEEDLE DETACHED FROM THE SUTURE WITHOUT UNDUE FORCE, COMPLICATING THE PROCEDURE. THE DETACHMENT OCCURRED WHILE SUTURING AFTER THE PATIENT INCISION. IT WAS CONFIRMED THAT THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471073 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN PROCEDURE TO REPAIR A SECOND DEGREE LACERATION, THE NEEDLE DETACHED FROM THE SUTURE TOWARDS THE END OF THE REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24465830 ↗MalfunctionFeb 20, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PERINEAL REPAIR PROCEDURE, THE NEEDLE JUST COMPLETELY POPPED OFF WHILE SUTURING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402378 ↗MalfunctionFeb 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VAGINAL LACERATION REPAIR PROCEDURE, THE NEEDLES POPPED OFF ON FIVE DIFFERENT SUTURES WHILE SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION. FIVE SUTURES WERE OPENED 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 24386198 ↗MalfunctionFeb 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VAGINAL LACERATION REPAIR PROCEDURE, THE NEEDLES POPPED OFF ON FIVE DIFFERENT SUTURES WHILE SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION. FIVE SUTURES WERE OPENED 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 24386197 ↗MalfunctionFeb 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VAGINAL LACERATION REPAIR PROCEDURE, THE NEEDLES POPPED OFF ON FIVE DIFFERENT SUTURES WHILE SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION. FIVE SUTURES WERE OPENED 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 24386160 ↗MalfunctionFeb 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VAGINAL LACERATION REPAIR PROCEDURE, THE NEEDLES POPPED OFF ON FIVE DIFFERENT SUTURES WHILE SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION. FIVE SUTURES WERE OPENED 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 24386133 ↗MalfunctionFeb 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VAGINAL LACERATION REPAIR PROCEDURE, THE NEEDLES POPPED OFF ON FIVE DIFFERENT SUTURES WHILE SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION. FIVE SUTURES WERE OPENED 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 24386129 ↗MalfunctionFeb 17, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, POST-OPERATIVELY ON A CLOSURE OF THE EPISIOTOMY WOUND, THE PATIENT RETURNED DUE TO UNBEARABLE PAIN AT THE EPISIOTOMY SITE. EXAMINATION REVEALED THAT THE WOUND HAD HEALED, BUT THE COSMETIC SUTURE HAD NOT BEEN FULLY ABSORBED. AFTER REMOVAL OF THE SUTURE AND DISINFECTION, THE SYMPTOMS WERE RELIEVED.
Patient problems: Pain
MAUDE report 24368861 ↗InjuryDec 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, A MEDIOLATERAL EPISIOTOMY DURING SPONTANEOUS DELIVERY ON (B)(6) 2025, A SYNTHETIC ABSORBABLE SURGICAL SUTURE WAS USED TO CLOSE THE WOUND. AT 10:30 ON (B)(6), THE PATIENT RETURNED FOR FOLLOW-UP DUE TO PERSISTENT SEVERE PAIN AT THE WOUND SITE. UPON EXAMINATION, THE DOCTOR FOUND THAT THE EPISIOTOMY WOUND HAD NOT HEALED AND THE ABSORBABLE SURGICAL SUTURE HAD NOT BEEN ABSORBED. THE DOCTOR REASSURED THE PATIENT AND EXPLAINED THE SITUATION; THE PATIENT UNDERSTOOD AND COOPERATED WITH THE TREATMENT. SUTURE REMOVAL, DISINFECTION, AND TWO SESSIONS OF INFRARED THERAPY WERE PROVIDED, AFTER WHICH THE PAIN WAS RELIEVED. ONE WEEK LATER, THE WOUND HAD HEALED COMPLETELY.
Patient problems: Pain; Unintended Radiation Exposure
MAUDE report 23918132 ↗InjuryMar 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, THE PATIENT GAVE BIRTH VAGINALLY ON (B)(6) 2025, AFTER EPISIOTOMY, THE WOUND WAS SUTURED WITH SYNTHETIC ABSORBABLE SURGICAL SUTURE. ON (B)(6) 2025, THE PATIENT EXPERIENCED PERSISTENT PERINEAL PAIN, WOUND REDNESS AND SWELLING AFTER DELIVERY. THE DOCTOR FOUND THAT SUPPURATION OCCURRED AT THE PERINEAL SUTURE. IT WAS NOTED THAT THERE WAS REJECTION OF SYNTHETIC ABSORBABLE SURGICAL SUTURE, WHICH WAS NOT ABSORBED, CAUSED AN ACUTE INFLAMMATORY RESPONSE. AFTER ANESTHESIA, THE SUTURE WAS REMOVED FROM THE PERINEUM, THE WOUND WAS CLEANED, THE PUS CAVITY WAS CLEANED, AND THE NECROTIC TISSUE WAS REMOVED. METRONIDAZOLE SODIUM CHLORIDE INJECTION AND CEFUROXIME SODIUM + 0.9% SODIUM CHLORIDE INJECTION WERE USED FOR INTRAVENOUS ANTIBACTERIAL TREATMENT, AND RIVANOL SOLUTION WAS USED FOR WET COMPRESS DISINFECTION. ON (B)(6) 2025, THE PERINEAL LACERATION WAS SUTURED AGAIN IN THE HOSPITAL, AND THE WOUND WAS SUTURED WITH NON-ABSORBABLE SURGICAL SUTURE, AND THE SUTURE WAS REMOVED AFTER FIVE DAYS.
Patient problems: Necrosis; Pain; Purulent Discharge; Swelling/ Edema
MAUDE report 21547178 ↗MalfunctionJan 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE ABSORBABLE SURGICAL SUTURE USED ON THE PATIENT'S WOUND AFTER THE OPERATION WAS NOT ABSORBED, WHICH AFFECTED THE HEALING OF THE INCISION. TO RESOLVE THE ISSUE, THE SUTURE WAS DIRECTLY REMOVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 21085230 ↗MalfunctionJan 6, 2025Device Slipped; Human-Device Interface Problem; Device Slipped; Human-Device Interface Problem
ACCORDING TO THE REPORTER, DURING A LATERAL EPISIOTOMY, AT THE TIME OF ROUTINE EPISIOTOMY SUTURE, SUTURE KNOTTING WAS DIFFICULT AND EASY TO SLIP. TO RESOLVE THE ISSUE, HEMOSTATIC FORCEPS WERE COOPERATED BY TWO PEOPLE TO TIE THE KNOT AGAIN. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21085229 ↗MalfunctionDec 9, 2024Break; Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING THE SUTURING PROCESS AFTER THE PATIENT'S DELIVERY, WHEN PASSING THROUGH THE MUSCLE LAYER AND GENTLY PULLING THE SUTURE TO TIE THE KNOT, THE SUTURE BROKE. THE SUTURE USE WAS IMMEDIATELY STOPPED. THE SUTURE WAS REPLACED WITH ONE FROM ANOTHER BATCH TO COMPLETE THE OPERATION. THE ISSUE PROLONGED THE OPERATION TIME BY 2-5 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20879537 ↗MalfunctionJan 4, 2024Break; Break
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHILE ON INSPECTION BEFORE USE, IT WAS REVEALED THAT THE SUTURE WAS COMMINUTEDLY BROKEN. TO RESOLVE THE ISSUE, THE SUTURE WAS REPLACED WITH A NEW SUTURE WITHOUT ANY ADVERSE EFFECTS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18445939 ↗InjuryJan 5, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, POSTOPERATIVELY TO A PERINEAL LATERAL INCISION DELIVERY BY LATERAL EPISIOTOMY, ABSORBABLE SUTURE WAS USED TO STOP BLEEDING. TWO DAYS LATER, A WOUND WAS NOTED AND FOUND TO BE A LITTLE RED AND DISASSEMBLED AND THE SUTURES WERE NOT ABSORBED. THE SUTURES WERE REMOVED AND TREATED WITH MICROWAVE.
Patient problems: Inflammation; Unspecified Tissue Injury; Wound Dehiscence
MAUDE report 16103823 ↗MalfunctionJun 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, 5 DAYS POST-OPERATIVELY WHERE THE DEVICE WAS USED FOR HEMOSTASIS, THE SUTURE DID NOT ABSORB AND THE WOUND WAS A LITTLE RED. DISINFECTION TREATMENT WAS GIVEN TO THE PATIENT.
Patient problems: Inflammation
MAUDE report 14747331 ↗
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.