Polysorb CL-812Recalls & reported problems
Covidien LP · Braided Absorbable Suture · Class 2 · Implant
Quick summary
This Covidien Polysorb absorbable surgical suture is a braided polyglycolic acid thread used to close tissue. Reports mostly describe the needle coming apart from the suture thread during surgery, sometimes after the first knot was tied, plus a few reports of the thread breaking. There are 69 reports, with no deaths and no injuries; a few mention cuts or a fragment left in the patient. 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
- 69
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 10884521049697), received between Dec 14, 2017 and Aug 24, 2026 — classified as 69 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (65 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 Component65
- Break5
- Insufficient Device Problem Information3
- Detachment Of Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions56
- Insufficient Information6
- No Known Impact Or Consequence To Patient5
- Laceration(s)4
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50407081 ↗MalfunctionAug 14, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50248852 ↗MalfunctionAug 14, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50248757 ↗MalfunctionAug 14, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50248677 ↗MalfunctionAug 13, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50234806 ↗MalfunctionAug 13, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50234773 ↗MalfunctionAug 13, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50234705 ↗MalfunctionMar 23, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A CESAREAN SECTION, THE NEEDLE DETACHED FROM THE SUTURE THREAD AFTER THE FIRST KNOT WAS TIED WITHOUT EXCESSIVE FORCE. THE ISSUE HAPPENED TO TWO MORE SUTURES. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24671678 ↗MalfunctionMar 23, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A CESAREAN SECTION, THE NEEDLE DETACHED FROM THE SUTURE THREAD AFTER THE FIRST KNOT WAS TIED WITHOUT EXCESSIVE FORCE. THE ISSUE HAPPENED TO TWO MORE SUTURES. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24671653 ↗MalfunctionMar 23, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A CESAREAN SECTION, THE NEEDLE DETACHED FROM THE SUTURE THREAD AFTER THE FIRST KNOT WAS TIED WITHOUT EXCESSIVE FORCE. A SECOND SUTURE HAD THE SAME ISSUE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24671614 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A CESAREAN SECTION, THE NEEDLE DETACHED FROM THE SUTURE THREAD AFTER THE FIRST KNOT WAS TIED WITHOUT EXCESSIVE FORCE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24455158 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A CESAREAN SECTION, THE NEEDLE DETACHED FROM THE SUTURE THREAD AFTER THE FIRST KNOT WAS TIED WITHOUT EXCESSIVE FORCE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454479 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A CESAREAN SECTION, THE NEEDLE DETACHED FROM THE SUTURE THREAD AFTER THE FIRST KNOT WAS TIED WITHOUT EXCESSIVE FORCE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454438 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A CESAREAN SECTION, THE NEEDLE DETACHED FROM THE SUTURE THREAD AFTER THE FIRST KNOT WAS TIED WITHOUT EXCESSIVE FORCE. A SECOND SUTURE HAD THE SAME ISSUE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454398 ↗MalfunctionJan 20, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE PERFORMING A CONTINUOUS SUTURE, THE NEEDLE UNEXPECTEDLY DETACHED ITSELF. THE SAME ISSUE OCCURRED ON THREE OTHER SUTURES FROM THE SAME BATCH. SEWING WAS PERFORMED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24121433 ↗MalfunctionJan 20, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE PERFORMING A CONTINUOUS SUTURE, THE NEEDLE UNEXPECTEDLY DETACHED ITSELF. THE SAME ISSUE OCCURRED ON THREE OTHER SUTURES FROM THE SAME BATCH. SEWING WAS PERFORMED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24121415 ↗MalfunctionJan 20, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE PERFORMING A CONTINUOUS SUTURE, THE NEEDLE UNEXPECTEDLY DETACHED ITSELF. THE SAME ISSUE OCCURRED ON THREE OTHER SUTURES FROM THE SAME BATCH. SEWING WAS PERFORMED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24121406 ↗MalfunctionJan 20, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE PERFORMING A CONTINUOUS SUTURE, THE NEEDLE UNEXPECTEDLY DETACHED ITSELF. THE SAME ISSUE OCCURRED ON THREE OTHER SUTURES FROM THE SAME BATCH. SEWING WAS PERFORMED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24121322 ↗MalfunctionJan 2, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ABDOMINOPLASTY, WITH LIPOSUCTION, FAT TRANSFER TO THE GLUTEAL AREA, MASTOPEXY WITH IMPLANTS, FLEUR-DE-LIS, AND BRACHIOPLASTY, WHILE USING THE DEVICE DURING MUSCLE APPLICATION, THE NEEDLE SEPARATED FROM THE SUTURE STRAND WHILE SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE DOCTOR REFUSED OTHER ALTERNATIVES AND, SINCE THERE WAS NO OTHER LOT NUMBER OF THE SAME TYPE, SUTURES WERE USED UNTIL ONE WAS FOUND THAT DID NOT DETACH. A TOTAL OF TEN SUTURES HAD THE SAME ISSUE. IT WAS NOTED THAT THE TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23952600 ↗MalfunctionJan 2, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ABDOMINOPLASTY, WITH LIPOSUCTION, FAT TRANSFER TO THE GLUTEAL AREA, MASTOPEXY WITH IMPLANTS, FLEUR-DE-LIS, AND BRACHIOPLASTY, WHILE USING THE DEVICE DURING MUSCLE APPLICATION, THE NEEDLE SEPARATED FROM THE SUTURE STRAND WHILE SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE DOCTOR REFUSED OTHER ALTERNATIVES AND, SINCE THERE WAS NO OTHER LOT NUMBER OF THE SAME TYPE, SUTURES WERE USED UNTIL ONE WAS FOUND THAT DID NOT DETACH. A TOTAL OF TEN SUTURES HAD THE SAME ISSUE. IT WAS NOTED THAT THE TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23952593 ↗MalfunctionJan 2, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ABDOMINOPLASTY, WITH LIPOSUCTION, FAT TRANSFER TO THE GLUTEAL AREA, MASTOPEXY WITH IMPLANTS, FLEUR-DE-LIS, AND BRACHIOPLASTY, WHILE USING THE DEVICE DURING MUSCLE APPLICATION, THE NEEDLE SEPARATED FROM THE SUTURE STRAND WHILE SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE DOCTOR REFUSED OTHER ALTERNATIVES AND, SINCE THERE WAS NO OTHER LOT NUMBER OF THE SAME TYPE, SUTURES WERE USED UNTIL ONE WAS FOUND THAT DID NOT DETACH. A TOTAL OF TEN SUTURES HAD THE SAME ISSUE. IT WAS NOTED THAT THE TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23952586 ↗MalfunctionJan 2, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ABDOMINOPLASTY, WITH LIPOSUCTION, FAT TRANSFER TO THE GLUTEAL AREA, MASTOPEXY WITH IMPLANTS, FLEUR-DE-LIS, AND BRACHIOPLASTY, WHILE USING THE DEVICE DURING MUSCLE APPLICATION, THE NEEDLE SEPARATED FROM THE SUTURE STRAND WHILE SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE DOCTOR REFUSED OTHER ALTERNATIVES AND, SINCE THERE WAS NO OTHER LOT NUMBER OF THE SAME TYPE, SUTURES WERE USED UNTIL ONE WAS FOUND THAT DID NOT DETACH. A TOTAL OF TEN SUTURES HAD THE SAME ISSUE. IT WAS NOTED THAT THE TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23952569 ↗MalfunctionJan 2, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ABDOMINOPLASTY, WITH LIPOSUCTION, FAT TRANSFER TO THE GLUTEAL AREA, MASTOPEXY WITH IMPLANTS, FLEUR-DE-LIS, AND BRACHIOPLASTY, WHILE USING THE DEVICE DURING MUSCLE APPLICATION, THE NEEDLE SEPARATED FROM THE SUTURE STRAND WHILE SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE DOCTOR REFUSED OTHER ALTERNATIVES AND, SINCE THERE WAS NO OTHER LOT NUMBER OF THE SAME TYPE, SUTURES WERE USED UNTIL ONE WAS FOUND THAT DID NOT DETACH. A TOTAL OF TEN SUTURES HAD THE SAME ISSUE. IT WAS NOTED THAT THE TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23952562 ↗MalfunctionJan 2, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ABDOMINOPLASTY, WITH LIPOSUCTION, FAT TRANSFER TO THE GLUTEAL AREA, MASTOPEXY WITH IMPLANTS, FLEUR-DE-LIS, AND BRACHIOPLASTY, WHILE USING THE DEVICE DURING MUSCLE APPLICATION, THE NEEDLE SEPARATED FROM THE SUTURE STRAND WHILE SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE DOCTOR REFUSED OTHER ALTERNATIVES AND, SINCE THERE WAS NO OTHER LOT NUMBER OF THE SAME TYPE, SUTURES WERE USED UNTIL ONE WAS FOUND THAT DID NOT DETACH. A TOTAL OF TEN SUTURES HAD THE SAME ISSUE. IT WAS NOTED THAT THE TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23952542 ↗MalfunctionJan 2, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ABDOMINOPLASTY, WITH LIPOSUCTION, FAT TRANSFER TO THE GLUTEAL AREA, MASTOPEXY WITH IMPLANTS, FLEUR-DE-LIS, AND BRACHIOPLASTY, WHILE USING THE DEVICE DURING MUSCLE APPLICATION, THE NEEDLE SEPARATED FROM THE SUTURE STRAND WHILE SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE DOCTOR REFUSED OTHER ALTERNATIVES AND, SINCE THERE WAS NO OTHER LOT NUMBER OF THE SAME TYPE, SUTURES WERE USED UNTIL ONE WAS FOUND THAT DID NOT DETACH. A TOTAL OF TEN SUTURES HAD THE SAME ISSUE. IT WAS NOTED THAT THE TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23952533 ↗
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.