Polysorb CL-923Recalls & reported problems
Covidien LP · Braided Absorbable Suture · Class 2 · Implant
Quick summary
This Covidien Polysorb absorbable suture is a braided thread used to close wounds that dissolves in the body. Of its 317 reports, 266 are malfunctions and 51 are injuries, mostly describing needles separating from the thread and threads breaking during use. No deaths are reported. No recalls name this device. Reports rose to 190 in the last 12 months from 13 in the previous 12.
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
- 321
- Deaths reported
- 0
- Injuries reported
- 51
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 321 adverse event reports that list this exact device (DI 10884521043404), received between Sep 8, 2017 and Sep 24, 2026 — classified as 51 injuries, 270 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (181 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 Component181
- Break83
- Patient-Device Incompatibility46
- Adverse Event Without Identified Device or Use Problem23
- Device Operates Differently Than Expected5
- Product Quality Problem5
- Insufficient Device Problem Information4
- Use of Device Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions201
- Insufficient Information44
- Pain32
- Impaired Healing20
- No Code Available14
- No Consequences Or Impact To Patient14
- Inflammation10
- No Known Impact Or Consequence To Patient8
Recent adverse event reports
The 25 most recent of 321 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883927 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
According to the reporter, during an open subcutaneous tissue suturing procedure, approximately 50 sutures experienced breakage at the needle-to-suture attachment site during continuous suturing. The problem was resolved only after sutures from a different batch were used for additional suturing. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883804 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
According to the reporter, during an open subcutaneous tissue suturing procedure, approximately 50 sutures experienced breakage at the needle-to-suture attachment site during continuous suturing. The problem was resolved only after sutures from a different batch were used for additional suturing. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883747 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
According to the reporter, during an open subcutaneous tissue suturing procedure, approximately 50 sutures experienced breakage at the needle-to-suture attachment site during continuous suturing. The problem was resolved only after sutures from a different batch were used for additional suturing. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883705 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
According to the reporter, during an open subcutaneous tissue suturing procedure, approximately 50 sutures experienced breakage at the needle-to-suture attachment site during continuous suturing. The problem was resolved only after sutures from a different batch were used for additional suturing. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883647 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883566 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
According to the reporter, during an open subcutaneous tissue suturing procedure, approximately 50 sutures experienced breakage at the needle-to-suture attachment site during continuous suturing. The problem was resolved only after sutures from a different batch were used for additional suturing. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883402 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883346 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
According to the reporter, during an open subcutaneous tissue suturing procedure, approximately 50 sutures experienced breakage at the needle-to-suture attachment site during continuous suturing. The problem was resolved only after sutures from a different batch were used for additional suturing. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883261 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
According to the reporter, during an open subcutaneous tissue suturing procedure, approximately 50 sutures experienced breakage at the needle-to-suture attachment site during continuous suturing. The problem was resolved only after sutures from a different batch were used for additional suturing. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882944 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
According to the reporter, during an open subcutaneous tissue suturing procedure, approximately 50 sutures experienced breakage at the needle-to-suture attachment site during continuous suturing. The problem was resolved only after sutures from a different batch were used for additional suturing. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882884 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
According to the reporter, during an open subcutaneous tissue suturing procedure, approximately 50 sutures experienced breakage at the needle-to-suture attachment site during continuous suturing. The problem was resolved only after sutures from a different batch were used for additional suturing. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882796 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
According to the reporter, during an open subcutaneous tissue suturing procedure, approximately 50 sutures experienced breakage at the needle-to-suture attachment site during continuous suturing. The problem was resolved only after sutures from a different batch were used for additional suturing. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882748 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829683 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820597 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
According to the reporter, during a an open orthopedic, trauma and muscle suturing, the surgeon employed interrupted sutures to close the muscle, the needle and thread detached when the surgeon tied the knot. The same issue occurred when two threads from the same batch were used consecutively. A new suture from a different batch was used to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818151 ↗MalfunctionAug 31, 2026Detachment of Device or Device Component
According to the reporter, during incision suturing, the needle separated from the thread on the first outward pull. A new suture was used to resolve the issue.
Patient problems: Insufficient Information
MAUDE report 50518400 ↗MalfunctionAug 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50210711 ↗MalfunctionAug 11, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209700 ↗MalfunctionAug 11, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209613 ↗MalfunctionAug 11, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209563 ↗MalfunctionAug 11, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209503 ↗MalfunctionAug 10, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50191530 ↗MalfunctionAug 10, 2026Detachment of Device or Device Component
According to the reporter, during a cesarean section under combined spinal-epidural anesthesia, the suture detached spontaneously from the needle. This occurred with three consecutive sutures. The suture was replaced to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50191519 ↗MalfunctionAug 10, 2026Detachment of Device or Device Component
According to the reporter, during a cesarean section under combined spinal-epidural anesthesia, the suture detached spontaneously from the needle. This occurred with three consecutive sutures. The suture was replaced to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50191507 ↗
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.