Polysorb CL-31-MGRecalls & 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
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521040496), received between Jan 11, 2024 and Aug 28, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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
- Patient-Device Incompatibility2
- Unraveled Material2
Patient problems
- Wound Dehiscence3
- Inflammation1
- Pain1
- Tissue Breakdown1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, 28 DAYS AFTER A HIP PROCEDURE, THE SUTURE HAD PREMATURE ABSORPTION. THE PATIENT HAD A SYSTEMIC INFECTION ON THE WOUND, INFLAMMATION, PAIN, AND REDNESS. THE PATIENT WAS READMITTED TO THE HOSPITAL AND HAD A REVISION TO EXPLANT THE SUTURES.
Patient problems: Inflammation; Pain; Tissue Breakdown; Unspecified Infection
MAUDE report 22911620 ↗MalfunctionSep 19, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, AFTER A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, THE THREE SUTURES USED WERE NOT ABSORBED. THERE WAS A WOUND DEHISCENCE.
Patient problems: Wound Dehiscence
MAUDE report 20258402 ↗InjuryJan 12, 2024Unraveled Material; Unraveled Material
ACCORDING TO THE REPORTER, THE INDEX PATIENT WAS PART OF A SERIES OF CERVICAL FASCIAL DEHISCENCE'S. THE SUTURE WAS OBSERVED TO BE FRIABLE AND DISSOLVED, WITH KNOTS STILL PRESENT, AND THE FASCIA/MUSCLE APPEARED HEALTHY BUT SEPARATED.
Patient problems: Wound Dehiscence
MAUDE report 18508773 ↗InjuryJan 11, 2024Unraveled Material; Unraveled Material
ACCORDING TO THE REPORTER, THE INDEX PATIENT WAS PART OF A SERIES OF CERVICAL FASCIAL DEHISCENCE'S. THE SUTURE WAS OBSERVED TO BE FRIABLE AND DISSOLVED, WITH KNOTS STILL PRESENT, AND THE FASCIA/MUSCLE APPEARED HEALTHY BUT SEPARATED.
Patient problems: Wound Dehiscence
MAUDE report 18499829 ↗
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
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- 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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