Polysorb SL-5687Recalls & reported problems
Covidien LP · Braided Absorbable Suture · Class 2 · Implant
Quick summary
This Covidien Polysorb suture is an absorbable braided thread used to close wounds and tissue. Its 154 reports mostly describe threads snapping during skin closure and needles detaching. The reports include no deaths and 5 injuries, and 149 are malfunctions. No recalls name this device. Reports rose from 9 in the year before to 124 in the latest year.
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
- 155
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 155 adverse event reports that list this exact device (DI 10884521048775), received between Jan 21, 2021 and Sep 29, 2026 — classified as 5 injuries, 150 malfunctions.
The most frequently reported specific device problem is “Break” (122 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
- Break122
- Detachment of Device or Device Component37
- Component Missing2
- No Apparent Adverse Event2
- Unraveled Material2
- Adverse Event Without Identified Device or Use Problem1
- Device Slipped1
- Human-Device Interface Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions143
- Insufficient Information59
- Unintended Radiation Exposure3
- Wound Dehiscence2
- Device Embedded In Tissue or Plaque1
- Pain1
Recent adverse event reports
The 25 most recent of 155 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934169 ↗MalfunctionMay 7, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, TWO NEEDLES DETACHED IN THE MIDDLE WHILE BEING REMOVED FROM THE RETAINER AND PREPARED PRIOR TO PATIENT INCISION. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT. .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25108166 ↗MalfunctionApr 1, 2026Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE SNAPPED AT THE MOMENT IT WAS PULLED WHILE CLOSING THE SKIN. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE, AND THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24761351 ↗MalfunctionMar 19, 2026Break
ACCORDING TO THE REPORTER, DURING A PEDIATRIC LUMP EXCISION OPEN PROCEDURE, THE SUTURE SNAPPED AT THE MOMENT IT WAS PULLED WHILE CLOSING THE SKIN. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE, AND THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24638494 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24456168 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24456128 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24456080 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24455952 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24455880 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24455797 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24455726 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24455652 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24455615 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24455507 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24455474 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24455423 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24455350 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24455286 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454760 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454703 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454671 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454473 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454435 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454404 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN OPEN SURGICAL SKIN SUTURING PROCEDURE, THE SUTURE NEEDLE AND THREAD BROKE WHILE SUTURING SKIN. 95 SUTURES WERE USED AND HAD THE SAME ISSUE. THE SUTURE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454356 ↗
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.