Polysorb CL-813Recalls & reported problems
Covidien LP · Braided Absorbable Suture · Class 2 · Implant
All models of Polysorb (291)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien Polysorb absorbable suture has 264 adverse event reports, including 263 malfunctions, 1 injury and no deaths. Reports mostly describe needles detaching from the thread and threads breaking during preparation, and several note that a new suture was used without issue. The count rose in the most recent 12 months, with 161 reports compared with 86 in the 12 months before. There are no recalls that 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
- 274
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 274 adverse event reports that list this exact device (DI 10884521041943), received between Aug 15, 2017 and Sep 23, 2026 — classified as 1 injury, 273 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (244 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component244
- Break53
- Insufficient Device Problem Information5
- Product Quality Problem3
- Detachment Of Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions241
- Insufficient Information51
- Foreign Body In Patient4
- No Consequences Or Impact To Patient3
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Unintended Radiation Exposure1
Recent adverse event reports
The 25 most recent of 274 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Detachment of Device or Device Component
According to the reporter, during a colon procedure, four needles detachment were observed. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869609 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
According to the reporter, during a colon procedure, four needles detachment were observed. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869573 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
According to the reporter, during a colon procedure, four needles detachment were observed. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869456 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
According to the reporter, during a gynecology procedure, four needles detachment were observed. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869339 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
According to the reporter, during a gynecology procedure, four needles detachment were observed. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869255 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
According to the reporter, during a gynecology procedure, four needles detachment were observed. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869098 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
According to the reporter, pre-operatively, while removing the suture from the retainer, the connection of the needle and thread broke. Another suture was used to complete the case. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854298 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
According to the reporter, pre-operatively, while removing the suture from the retainer, the connection of the needle and thread broke. Another suture was used to complete the case. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854188 ↗MalfunctionSep 17, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809884 ↗MalfunctionSep 17, 2026Detachment of Device or Device Component
According to the reporter, during a procedure, needle detachment was observed. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802619 ↗MalfunctionJun 9, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VENTRAL HERNIORRHAPHY, WHILE REMOVING THE SUTURE FROM THE RETAINER, FIVE NEEDLES DETACHED. 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 25448246 ↗MalfunctionJun 9, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VENTRAL HERNIORRHAPHY, WHILE REMOVING THE SUTURE FROM THE RETAINER, FIVE NEEDLES DETACHED. 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 25448205 ↗MalfunctionJun 9, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VENTRAL HERNIORRHAPHY, WHILE REMOVING THE SUTURE FROM THE RETAINER, FIVE NEEDLES DETACHED. 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 25448123 ↗MalfunctionMay 6, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING CESAREAN SECTION ABDOMINAL CLOSURE, THE SUTURE WAS DAMAGED AT THE SWAGE PART. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25090045 ↗MalfunctionApr 12, 2026Break
IT WAS REPORTED THAT PREOPERATIVELY, WHEN USER TRIED TO REMOVE THE SUTURE FROM THE PACKAGING BY PULLING ON THE NEEDLE, THE THREAD BROKE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853041 ↗MalfunctionApr 12, 2026Break
IT WAS REPORTED THAT PREOPERATIVELY, WHEN USER TRIED TO REMOVE THE SUTURE FROM THE PACKAGING BY PULLING ON THE NEEDLE, THE THREAD BROKE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853039 ↗MalfunctionApr 12, 2026Break
IT WAS REPORTED THAT PREOPERATIVELY, WHEN USER TRIED TO REMOVE THE SUTURE FROM THE PACKAGING BY PULLING ON THE NEEDLE, THE THREAD BROKE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853022 ↗MalfunctionApr 11, 2026Break
IT WAS REPORTED THAT PREOPERATIVELY, WHEN USER TRIED TO REMOVE THE SUTURE FROM THE PACKAGING BY PULLING ON THE NEEDLE, THE THREAD BROKE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24850681 ↗MalfunctionApr 11, 2026Break
IT WAS REPORTED THAT PREOPERATIVELY, WHEN USER TRIED TO REMOVE THE SUTURE FROM THE PACKAGING BY PULLING ON THE NEEDLE, THE THREAD BROKE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24849551 ↗MalfunctionApr 11, 2026Break
IT WAS REPORTED THAT PREOPERATIVELY, WHEN USER TRIED TO REMOVE THE SUTURE FROM THE PACKAGING BY PULLING ON THE NEEDLE, THE THREAD BROKE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24849443 ↗MalfunctionApr 11, 2026Break
IT WAS REPORTED THAT PREOPERATIVELY, WHEN USER TRIED TO REMOVE THE SUTURE FROM THE PACKAGING BY PULLING ON THE NEEDLE, THE THREAD BROKE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24849353 ↗MalfunctionApr 11, 2026Break
IT WAS REPORTED THAT PREOPERATIVELY, WHEN USER TRIED TO REMOVE THE SUTURE FROM THE PACKAGING BY PULLING ON THE NEEDLE, THE THREAD BROKE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24849283 ↗MalfunctionApr 11, 2026Break
IT WAS REPORTED THAT PREOPERATIVELY, WHEN USER TRIED TO REMOVE THE SUTURE FROM THE PACKAGING BY PULLING ON THE NEEDLE, THE THREAD BROKE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24849181 ↗MalfunctionApr 11, 2026Break
IT WAS REPORTED THAT PREOPERATIVELY, WHEN USER TRIED TO REMOVE THE SUTURE FROM THE PACKAGING BY PULLING ON THE NEEDLE, THE THREAD BROKE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24849133 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS SUTURE BREAKAGE. THIS ISSUE OCCURRED ON TWO DEVICES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24709056 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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