Polysorb CL-936Recalls & reported problems
Covidien LP · Braided Absorbable Suture · Class 2 · Implant
Quick summary
This Covidien Polysorb CL-936 is a braided absorbable synthetic suture used to close tissue during surgery. There are 27 adverse event reports, and they mostly describe the needle coming loose or breaking away from the suture thread mid-operation, in most cases during joint repair or internal fixation, with surgeons switching to a new suture to finish. No deaths and no injuries were reported. There are no recalls for this device. Reports rose sharply, from 5 in the earlier 12 months to 21 in the most recent.
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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884521043527), received between Feb 7, 2019 and Feb 18, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (26 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 Component26
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A OPEN REDUCTION AND INTERNAL FIXATION (ORIF), WHILE SUTURING, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL 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 24380657 ↗MalfunctionFeb 18, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF), DURING SUTURING, THE NEEDLE DETACHED ON THREE SUTURES. A NEW SUTURE WAS USED 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 24379490 ↗MalfunctionFeb 18, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF), DURING SUTURING, THE NEEDLE DETACHED ON THREE SUTURES. A NEW SUTURE WAS USED 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 24379487 ↗MalfunctionFeb 18, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF), DURING SUTURING, THE NEEDLE DETACHED ON THREE SUTURES. A NEW SUTURE WAS USED 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 24379437 ↗MalfunctionFeb 5, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING, THE CONNECTION OF THE NEEDLE AND THREAD BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24273423 ↗MalfunctionFeb 5, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING, THE NEEDLE DETACHED FROM THE THREAD. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24271250 ↗MalfunctionFeb 3, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE HEMIARTHROPLASTY, A TOTAL OF FIVE SUTURES EXPERIENCED NEEDLE DETACHMENT WHILE BEING REMOVED FROM THE RETAINER. 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 24255206 ↗MalfunctionFeb 3, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE HEMIARTHROPLASTY, A TOTAL OF FIVE SUTURES EXPERIENCED NEEDLE DETACHMENT WHILE BEING REMOVED FROM THE RETAINER. 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 24255204 ↗MalfunctionFeb 3, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE HEMIARTHROPLASTY, A TOTAL OF FIVE SUTURES EXPERIENCED NEEDLE DETACHMENT WHILE BEING REMOVED FROM THE RETAINER. 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 24255182 ↗MalfunctionFeb 3, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE HEMIARTHROPLASTY, A TOTAL OF FIVE SUTURES EXPERIENCED NEEDLE DETACHMENT WHILE BEING REMOVED FROM THE RETAINER. 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 24255179 ↗MalfunctionFeb 3, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE HEMIARTHROPLASTY, A TOTAL OF FIVE SUTURES EXPERIENCED NEEDLE DETACHMENT WHILE BEING REMOVED FROM THE RETAINER. 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 24255169 ↗MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE, THE NEEDLE DETACHED FROM THE SWAGE POINT. TO RESOLVE THE ISSUE, A NEW DEVICE FROM A DIFFERENT LOT NUMBER WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23873452 ↗MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE, THE NEEDLE DETACHED FROM THE SWAGE POINT. TO RESOLVE THE ISSUE, A NEW DEVICE FROM A DIFFERENT LOT NUMBER WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23873419 ↗MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE, THE NEEDLE DETACHED FROM THE SWAGE POINT. TO RESOLVE THE ISSUE, A NEW DEVICE FROM A DIFFERENT LOT NUMBER WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23873394 ↗MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE, THE NEEDLE DETACHED FROM THE SWAGE POINT. TO RESOLVE THE ISSUE, A NEW DEVICE FROM A DIFFERENT LOT NUMBER WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23873385 ↗MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE, THE NEEDLE DETACHED FROM THE SWAGE POINT. TO RESOLVE THE ISSUE, A NEW DEVICE FROM A DIFFERENT LOT NUMBER WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23873364 ↗MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE, THE NEEDLE DETACHED FROM THE SWAGE POINT. TO RESOLVE THE ISSUE, A NEW DEVICE FROM A DIFFERENT LOT NUMBER WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23873311 ↗MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE NEEDLE DETACHED FROM THE SWAGE POINT WHILE SUTURING, RESULTING IN THE NEEDLE FALLING INTO THE PATIENT CAVITY. THE SURGEON IMMEDIATELY RETRIEVED THE NEEDLE FROM THE CAVITY. THE SUTURE WAS REPORTED TO BE CONTINUOUSLY BREAKING, AND MULTIPLE DEVICES FROM THE SAME LOT WERE INVOLVED IN THE EVENT. THE PROCEDURE WAS EXTENDED BY 15 MINUTES DUE TO THESE ISSUES. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23710969 ↗MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ORTHOPEDIC SURGICAL PROCEDURE, THE NEEDLE DETACHED FROM THE SWAGE POINT WHILE SUTURING, RESULTING IN THE NEEDLE FALLING INTO THE PATIENT'S CAVITY. THE SURGEON IMMEDIATELY RETRIEVED THE NEEDLE FROM THE CAVITY. THE SUTURE WAS REPORTEDTO BE CONTINUOUSLY BREAKING, AND MULTIPLE DEVICES FROM THE SAME LOT WERE INVOLVED IN THE EVENT. THE PROCEDURE WAS EXTENDED BY 15 MINUTES DUE TO THESE ISSUES. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23710869 ↗MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE NEEDLE DETACHED FROM THE SWAGE POINT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23710693 ↗MalfunctionNov 22, 2025Break; Break
IT WAS REPORTED THAT DURING A HIP REPLACEMENT SURGERY, WHILE SUTURING , THE SUTURE BROKE IN THE MIDDLE. 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 23625121 ↗MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, FOUR SUTURES BROKE WHILE SUTURING AT THE CONNECTION OF THE NEEDLE AND THREAD. ADDITIONAL NEW SUTURES WERE 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 22470229 ↗MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, FOUR SUTURES BROKE WHILE SUTURING AT THE CONNECTION OF THE NEEDLE AND THREAD. ADDITIONAL NEW SUTURES WERE 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 22469931 ↗MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, FOUR SUTURES BROKE WHILE SUTURING AT THE CONNECTION OF THE NEEDLE AND THREAD. ADDITIONAL NEW SUTURES WERE 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 22469768 ↗MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, FOUR SUTURES BROKE WHILE SUTURING AT THE CONNECTION OF THE NEEDLE AND THREAD. ADDITIONAL NEW SUTURES WERE 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 22469741 ↗
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.