Polysorb SL-712Recalls & reported problems
Covidien LP · Braided Absorbable Suture · Class 2 · Implant
Quick summary
This Covidien Polysorb absorbable suture is a braided thread that dissolves in the body over time. Its 185 reports include no deaths and no injuries. Almost all describe the suture breaking during use, sometimes with several sutures from the same box failing, and a few describe the needle coming off, including in some veterinary procedures. 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
- 185
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 185 adverse event reports that list this exact device (DI 10884521049284), received between Dec 28, 2018 and Jul 2, 2026 — classified as 185 malfunctions.
The most frequently reported specific device problem is “Break” (182 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
- Break182
- Adverse Event Without Identified Device or Use Problem3
- Detachment of Device or Device Component3
Patient problems
- No Clinical Signs, Symptoms or Conditions132
- Insufficient Information71
- No Patient Involvement1
- Wound Dehiscence1
Recent adverse event reports
The 25 most recent of 185 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, NEEDLE DETACHMENT OCCURRED WHILE REMOVING SUTURE FROM THE RETAINER. A SECOND SUTURE FROM THE SAME LOT HAD THE SAME ISSUE. AN ADDITIONAL SUTURE WAS USED WITHOUT ISSUE. THE PROBLEM WAS DISCOVERED BEFORE USE ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25686716 ↗MalfunctionJul 2, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, NEEDLE DETACHMENT OCCURRED WHILE REMOVING SUTURE FROM THE RETAINER. A SECOND SUTURE FROM THE SAME LOT HAD THE SAME ISSUE. AN ADDITIONAL SUTURE WAS USED WITHOUT ISSUE. THE PROBLEM WAS DISCOVERED BEFORE USE ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25686710 ↗MalfunctionOct 4, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, FIVE SUTURES FROM THE SAME BOX WERE USED AND ALL OF THEM BROKE DURING USE, AND A DIFFERENT SUTURES HAD TO BE TRIED FIVE TIMES WITH SAME RESULT. THERE WAS NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20372370 ↗MalfunctionOct 4, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, FIVE SUTURES FROM THE SAME BOX WERE USED AND ALL OF THEM BROKE DURING USE, AND A DIFFERENT SUTURES HAD TO BE TRIED FIVE TIMES WITH SAME RESULT. THERE WAS NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20371634 ↗MalfunctionOct 4, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, FIVE SUTURES FROM THE SAME BOX WERE USED AND ALL OF THEM BROKE DURING USE, AND A DIFFERENT SUTURES HAD TO BE TRIED FIVE TIMES WITH SAME RESULT. THERE WAS NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20371525 ↗MalfunctionOct 4, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, FIVE SUTURES FROM THE SAME BOX WERE USED AND ALL OF THEM BROKE DURING USE, AND A DIFFERENT SUTURES HAD TO BE TRIED FIVE TIMES WITH SAME RESULT. THERE WAS NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20371503 ↗MalfunctionOct 4, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, FIVE SUTURES FROM THE SAME BOX WERE USED AND ALL OF THEM BROKE DURING USE, AND A DIFFERENT SUTURES HAD TO BE TRIED FIVE TIMES WITH SAME RESULT. THERE WAS NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20371437 ↗MalfunctionSep 26, 2024Break; Break
ACCORDING TO THE REPORTER, THE SUTURE BROKE WITH EACH USE.
Patient problems: Insufficient Information
MAUDE report 20313265 ↗MalfunctionFeb 27, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WOUND CLOSURE, THE THREAD BROKE WHEN THE KNOT WAS TIGHTENED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 18794432 ↗MalfunctionFeb 27, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY DOG OVARIECTOMIES, THE THREAD BROKE DURING PULLING. THERE WAS A LITTLE BLOOD LOSS (LESS THAN 250CC, JUST A LITTLE BIT). A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18794429 ↗MalfunctionFeb 27, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY DOG OVARIECTOMIES, THE THREAD BROKE DURING PULLING. THERE WAS A LITTLE BLOOD LOSS (LESS THAN 250CC, JUST A LITTLE BIT). A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18794408 ↗MalfunctionFeb 27, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY DOG OVARIECTOMIES, THE THREAD BROKE DURING PULLING. THERE WAS A LITTLE BLOOD LOSS (LESS THAN 250CC, JUST A LITTLE BIT). A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18794395 ↗MalfunctionFeb 27, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, AMPUTATION, THE THREAD BROKE WHEN THE KNOT WAS TIGHTENED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 18793961 ↗MalfunctionFeb 27, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE THREAD BROKE DURING PULLING. A LITTLE BLOOD LOSS (LESS THAN 250CC, JUST A LITTLE BIT). A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18793863 ↗MalfunctionFeb 27, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE THREAD BROKE DURING PULLING. A LITTLE BLOOD LOSS (LESS THAN 250CC, JUST A LITTLE BIT). A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18793843 ↗MalfunctionFeb 27, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE THREAD BROKE DURING PULLING. A LITTLE BLOOD LOSS (LESS THAN 250CC, JUST A LITTLE BIT). A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18793790 ↗MalfunctionFeb 27, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE THREAD BROKE DURING PULLING. A LITTLE BLOOD LOSS (LESS THAN 250CC, JUST A LITTLE BIT). A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18793724 ↗MalfunctionFeb 27, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY DOG OVARIECTOMIES, THE THREAD BROKE DURING PULLING. A LITTLE BLOOD LOSS (LESS THAN 250CC, JUST A LITTLE BIT). A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18792998 ↗MalfunctionFeb 27, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY DOG OVARIECTOMIES, THE THREAD BROKE DURING PULLING. A LITTLE BLOOD LOSS (LESS THAN 250CC, JUST A LITTLE BIT). A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18792948 ↗MalfunctionFeb 27, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE THREAD BROKE DURING PULLING. A LITTLE BLOOD LOSS (LESS THAN 250CC, JUST A LITTLE BIT). A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18792860 ↗MalfunctionFeb 27, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE THREAD BROKE DURING PULLING. A LITTLE BLOOD LOSS (LESS THAN 250CC, JUST A LITTLE BIT). A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18792293 ↗MalfunctionFeb 27, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE THREAD BROKE DURING PULLING. A LITTLE BLOOD LOSS (LESS THAN 250CC, JUST A LITTLE BIT). A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18792272 ↗MalfunctionDec 27, 2023Break; Break
ACCORDING TO THE REPORTER, ALL 31 SUTURE THREAD BROKE.
Patient problems: Insufficient Information
MAUDE report 18406839 ↗MalfunctionDec 27, 2023Break; Break
ACCORDING TO THE REPORTER, ALL 31 SUTURE THREAD BROKE.
Patient problems: Insufficient Information
MAUDE report 18406518 ↗MalfunctionDec 27, 2023Break; Break
ACCORDING TO THE REPORTER, ALL 31 SUTURE THREAD BROKE.
Patient problems: Insufficient Information
MAUDE report 18406484 ↗
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.