Polysorb GL-223Recalls & reported problems
Covidien LP · Braided Absorbable Suture · Class 2 · Implant
Quick summary
This Covidien Polysorb GL-223 suture is an absorbable braided synthetic suture. Reports mostly describe thread breakage, needle detachment before use, unraveling, and wound reopening or seroma. There are 80 reports, with 35 injuries, no deaths, and 45 malfunctions. No recalls name this device, and the last 12 months had 0 reports versus 16 in the prior 12 months.
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
- 82
- Deaths reported
- 0
- Injuries reported
- 37
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10884521045149), received between Jan 26, 2016 and Sep 22, 2026 — classified as 37 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Break” (33 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
- Break33
- Patient-Device Incompatibility32
- Detachment of Device or Device Component24
- Unraveled Material20
- Detachment Of Device Component6
- Material Protrusion/Extrusion5
- Adverse Event Without Identified Device or Use Problem3
- Material Puncture/Hole2
Patient problems
- No Code Available25
- Wound Dehiscence20
- Reaction16
- No Known Impact Or Consequence To Patient14
- Radiation Exposure, Unintended10
- Seroma10
- No Clinical Signs, Symptoms or Conditions9
- No Consequences Or Impact To Patient7
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Patient-Device Incompatibility
According to the reporter, on(b)(6) 2026, the incision had been closed with 2-0 suture. Hence, on (b)(6) 2026, it was noted that there was a suture reaction which caused physical suffering, including wound redness, swelling, exudate, and increased pain; prolonged healing and hospitalization; required additional anti-infective treatment and repeat suturing; increased medical expenses; delayed rehabilitation; and caused anxiety.
Patient problems: Anxiety; Discomfort; Fluid Discharge; Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema
MAUDE report 50854748 ↗InjurySep 21, 2026Patient-Device Incompatibility
Patient problems: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Fluid Discharge; Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema
MAUDE report 50848951 ↗MalfunctionOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE TWO NEEDLES WERE DETACHED FROM THE THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23358837 ↗MalfunctionOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRIOR TO USE, THE TWO NEEDLES WERE DETACHED FROM THE THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23358828 ↗MalfunctionJun 20, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, THE SUTURE CAUSES SERUM INTO THE WOUND AFTER A FEW DAYS.
Patient problems: Seroma
MAUDE report 22297954 ↗MalfunctionJun 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT APPROXIMATELY TEN DAYS AFTER A VETERINARIAN PROCEDURE INVOLVING THE USE OF NINE SUTURES, A SERUM WAS OBSERVED IN THE WOUND.
Patient problems: Seroma
MAUDE report 22248350 ↗MalfunctionJun 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT APPROXIMATELY TEN DAYS AFTER A VETERINARIAN PROCEDURE INVOLVING THE USE OF NINE SUTURES, A SERUM WAS OBSERVED IN THE WOUND.
Patient problems: Seroma
MAUDE report 22248339 ↗MalfunctionJun 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT APPROXIMATELY TEN DAYS AFTER A VETERINARIAN PROCEDURE INVOLVING THE USE OF NINE SUTURES, A SERUM WAS OBSERVED IN THE WOUND.
Patient problems: Seroma
MAUDE report 22248335 ↗MalfunctionJun 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT APPROXIMATELY TEN DAYS AFTER A VETERINARIAN PROCEDURE INVOLVING THE USE OF NINE SUTURES, A SERUM WAS OBSERVED IN THE WOUND.
Patient problems: Seroma
MAUDE report 22248331 ↗MalfunctionJun 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT APPROXIMATELY TEN DAYS AFTER A VETERINARIAN PROCEDURE INVOLVING THE USE OF NINE SUTURES, A SERUM WAS OBSERVED IN THE WOUND.
Patient problems: Seroma
MAUDE report 22248278 ↗MalfunctionJun 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT APPROXIMATELY TEN DAYS AFTER A VETERINARIAN PROCEDURE INVOLVING THE USE OF NINE SUTURES, A SERUM WAS OBSERVED IN THE WOUND.
Patient problems: Seroma
MAUDE report 22248236 ↗MalfunctionJun 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT APPROXIMATELY TEN DAYS AFTER A VETERINARIAN PROCEDURE INVOLVING THE USE OF NINE SUTURES, A SERUM WAS OBSERVED IN THE WOUND.
Patient problems: Seroma
MAUDE report 22248230 ↗MalfunctionJun 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT APPROXIMATELY TEN DAYS AFTER A VETERINARIAN PROCEDURE INVOLVING THE USE OF NINE SUTURES, A SERUM WAS OBSERVED IN THE WOUND.
Patient problems: Seroma
MAUDE report 22248198 ↗MalfunctionJun 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT APPROXIMATELY TEN DAYS AFTER A VETERINARIAN PROCEDURE INVOLVING THE USE OF NINE SUTURES, A SERUM WAS OBSERVED IN THE WOUND.
Patient problems: Seroma
MAUDE report 22248135 ↗MalfunctionApr 3, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF THREE TIMES. THE SUTURES WERE REMOVED AS PART OF THE ACTIONS TAKEN.
Patient problems: Insufficient Information
MAUDE report 21760017 ↗MalfunctionApr 3, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF THREE TIMES. THE SUTURES WERE REMOVED AS PART OF THE ACTIONS TAKEN.
Patient problems: Insufficient Information
MAUDE report 21760003 ↗MalfunctionApr 3, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF THREE TIMES. THE SUTURES WERE REMOVED AS PART OF THE ACTIONS TAKEN.
Patient problems: Insufficient Information
MAUDE report 21759987 ↗MalfunctionNov 28, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ACCORDING TO THE REPORTER, WHEN SCRUB NURSE OPENED THE PACKET IN STERILE FIELD, FOUND TWO NEEDLES INSIDE, INSTEAD OF JUST ONE, AS INDICATED IN THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20805971 ↗MalfunctionOct 24, 2024Break; Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A HERNIA REPAIR, THE TIP OF THE NEEDLE BROKE. THE NEEDLE FELL IN THE PATIENT CAVITY AND WAS RETRIEVED VIA NEEDLE HOLDER AS NOTICED BY THE SURGEON. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20523162 ↗MalfunctionAug 5, 2024Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TIP OF THE SUTURE WENT MISSING AND THE REMAINING PORTION WAS BENT. THE SURGEON REASSURED THE HEALTHCARE TEAM THAT IT WAS NOT INSIDE THE PATIENT. X-RAY WAS DISCUSSED, BUT THE SURGEON CONFIRMED IT WOULD BE TOO SMALL TO LOCATE WITH AN X-RAY. THE SURGEON SEARCHED THE DRAPES, OPERATING SCRUB TROLLEY, AND OPERATING FLOOR WITHOUT SUCCESS IN LOCATING IT.
Patient problems: Insufficient Information
MAUDE report 19906878 ↗MalfunctionJun 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BECAME DETACHED FROM THE SUTURE AND WAS INSIDE THE PATIENT WHICH HAD TO BE RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 19511152 ↗MalfunctionMay 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, THE TWO NEEDLES AND THREADS GOT SEPARATED WHEN THE SURGEON STARTED TO USE THE DEVICE. ALSO, THE NEEDLE FELL INTO THE CAVITY OF THE PATIENT BUT THE USER WAS ABLE TO FIND IT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19320333 ↗MalfunctionFeb 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, AS SOON AS THE PACKAGE WAS OPENED, IT WAS SEEN THAT THE NEEDLE AND THREAD WERE SEPARATED FOR BOTH DEVICE. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18692481 ↗MalfunctionOct 25, 2021Break; Break
ACCORDING TO THE REPORTER, DURING SURGICAL LAPAROTOMY IN GENERAL SURGERY VIA LAPAROSCOPIC PROCEDURE, WHILE TRANSFUSION & SUTURING OF THE MUSCLE, BOTH THREADS BROKE. TO COMPLETE THE CASE, THE SURGEON USED A NEW SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12689636 ↗MalfunctionSep 3, 2021Break; Break
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, WHEN CLOSING OUTER LAYER, A NEEDLE BROKE. THE SUTURE FOIL WAS REPLACED TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12421318 ↗
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.