Polysorb CL-894Recalls & reported problems
Covidien LP · Braided Absorbable Suture · Class 2 · Implant
Quick summary
This Covidien Polysorb CL-894 is a braided absorbable surgical suture. Most of the 48 reports describe the needle coming loose or detaching from the suture thread, sometimes during a procedure and sometimes when opening the package, with a few mentioning a broken or mispackaged product. No deaths and no injuries were reported. There are no recalls naming this device, and no reports in the last 12 months compared with 4 in the prior12 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
- 48
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10884521042902), received between Sep 7, 2022 and Dec 30, 2024 — classified as 48 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (47 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 Component47
- Break1
- Insufficient Device Problem Information1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- Insufficient Information7
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WAS AN EVENT INVOLVING CL-894 POLYSORB* 0 VIO 75CM GS23 X36, FROM WHICH THE NEEDLE HAS BEEN REMOVED FROM THE THREAD THREE TIMES.
Patient problems: Insufficient Information
MAUDE report 21033105 ↗MalfunctionNov 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE CAME LOOSE FROM THE THREAD. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 20664562 ↗MalfunctionNov 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE CAME LOOSE FROM THE THREAD.
Patient problems: Insufficient Information
MAUDE report 20640643 ↗MalfunctionNov 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE CAME LOOSE FROM THE THREAD.
Patient problems: Insufficient Information
MAUDE report 20640618 ↗MalfunctionOct 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PREOPERATIVELY, THE THREE NEEDLES DETACHED FROM THE THREAD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20456661 ↗MalfunctionOct 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PREOPERATIVELY, THE THREE NEEDLES DETACHED FROM THE THREAD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20456149 ↗MalfunctionOct 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN CLOSING, THE THREE NEEDLES DETACHED FROM THE THREAD. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20455984 ↗MalfunctionOct 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN REMOVING THE NEEDLE FROM THE RETAINER THE NEEDLE DETACHED FOR BOTH DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20450886 ↗MalfunctionOct 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN REMOVING THE NEEDLE FROM THE RETAINER THE NEEDLE DETACHED FOR BOTH DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20450784 ↗MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHILE SUTURING THE FASCIA, AFTER INSERTING THE NEEDLE INTO THE TISSUE AND MAKING ONE TO TWO STITCHES, THE NEEDLE SEPARATED FROM THE THREAD. IT WAS IMPOSSIBLE TO COMPLETE THE SUTURING WITH THE THREAD. THE SAME ISSUE OCCURRED WITH TWO OTHER SUTURES. A NEW SUTURE FROM THE SAME BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20323093 ↗MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHILE SUTURING THE FASCIA, AFTER INSERTING THE NEEDLE INTO THE TISSUE AND MAKING ONE TO TWO STITCHES, THE NEEDLE SEPARATED FROM THE THREAD. IT WAS IMPOSSIBLE TO COMPLETE THE SUTURING WITH THE THREAD. THE SAME ISSUE OCCURRED WITH TWO OTHER SUTURES. A NEW SUTURE FROM THE SAME BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20323026 ↗MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHILE SUTURING THE FASCIA, AFTER INSERTING THE NEEDLE INTO THE TISSUE AND MAKING ONE TO TWO STITCHES, THE NEEDLE SEPARATED FROM THE THREAD. IT WAS IMPOSSIBLE TO COMPLETE THE SUTURING WITH THE THREAD. THE SAME ISSUE OCCURRED WITH TWO OTHER SUTURES. A NEW SUTURE FROM THE SAME BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20323025 ↗MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING THE FASCIA, AFTER INSERTING THE NEEDLE INTO THE TISSUE AND MAKING ONE TO TWO STITCHES, THE NEEDLE SEPARATED FROM THE THREAD. IT WAS IMPOSSIBLE TO COMPLETE THE SUTURING WITH THE THREAD. THE SAME ISSUE OCCURRED WITH TWO OTHER SUTURES. A NEW SUTURE FROM THE SAME BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20323014 ↗MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHILE SUTURING THE FASCIA, AFTER INSERTING THE NEEDLE INTO THE TISSUE AND MAKING ONE TO TWO STITCHES, THE NEEDLE SEPARATED FROM THE THREAD. IT WAS IMPOSSIBLE TO COMPLETE THE SUTURING WITH THE THREAD. THE SAME ISSUE OCCURRED WITH THREE OTHER SUTURES. A NEW SUTURE FROM THE SAME BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20322985 ↗MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHILE SUTURING THE FASCIA, AFTER INSERTING THE NEEDLE INTO THE TISSUE AND MAKING ONE TO TWO STITCHES, THE NEEDLE SEPARATED FROM THE THREAD. IT WAS IMPOSSIBLE TO COMPLETE THE SUTURING WITH THE THREAD. THE SAME ISSUE OCCURRED WITH THREE OTHER SUTURES. A NEW SUTURE FROM THE SAME BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20322984 ↗MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING THE FASCIA, AFTER INSERTING THE NEEDLE INTO THE TISSUE AND MAKING ONE TO TWO STITCHES, THE NEEDLE SEPARATED FROM THE THREAD. IT WAS IMPOSSIBLE TO COMPLETE THE SUTURING WITH THE THREAD. THE SAME ISSUE OCCURRED WITH TWO OTHER SUTURES. A NEW SUTURE FROM THE SAME BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20322889 ↗MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING THE FASCIA, AFTER INSERTING THE NEEDLE INTO THE TISSUE AND MAKING ONE TO TWO STITCHES, THE NEEDLE SEPARATED FROM THE THREAD. IT WAS IMPOSSIBLE TO COMPLETE THE SUTURING WITH THE THREAD. THE SAME ISSUE OCCURRED WITH TWO OTHER SUTURES. A NEW SUTURE FROM THE SAME BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20322874 ↗MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHILE SUTURING THE FASCIA, AFTER INSERTING THE NEEDLE INTO THE TISSUE AND MAKING ONE TO TWO STITCHES, THE NEEDLE SEPARATED FROM THE THREAD. IT WAS IMPOSSIBLE TO COMPLETE THE SUTURING WITH THE THREAD. THE SAME ISSUE OCCURRED WITH TWO OTHER SUTURES. A NEW SUTURE FROM THE SAME BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20322873 ↗MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING THE FASCIA, AFTER INSERTING THE NEEDLE INTO THE TISSUE AND MAKING ONE TO TWO STITCHES, THE NEEDLE SEPARATED FROM THE THREAD. IT WAS IMPOSSIBLE TO COMPLETE THE SUTURING WITH THE THREAD. THE SAME ISSUE OCCURRED WITH TWO OTHER SUTURES. A NEW SUTURE FROM THE SAME BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20322799 ↗MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHILE SUTURING THE FASCIA, AFTER INSERTING THE NEEDLE INTO THE TISSUE AND MAKING ONE TO TWO STITCHES, THE NEEDLE SEPARATED FROM THE THREAD. IT WAS IMPOSSIBLE TO COMPLETE THE SUTURING WITH THE THREAD. THE SAME ISSUE OCCURRED WITH THREE OTHER SUTURES. A NEW SUTURE FROM THE SAME BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20322663 ↗MalfunctionSep 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING THE FASCIA, AFTER INSERTING THE NEEDLE INTO THE TISSUE AND MAKING ONE TO TWO STITCHES, THE NEEDLE SEPARATED FROM THE THREAD. IT WAS IMPOSSIBLE TO COMPLETE THE SUTURING WITH THE THREAD. THE SAME ISSUE OCCURRED WITH TWO OTHER SUTURES. A NEW SUTURE FROM THE SAME BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20307200 ↗MalfunctionSep 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING THE FASCIA, AFTER INSERTING THE NEEDLE INTO THE TISSUE AND MAKING ONE TO TWO STITCHES, THE NEEDLE SEPARATED FROM THE THREAD. IT WAS IMPOSSIBLE TO COMPLETE THE SUTURING WITH THE THREAD. THE SAME ISSUE OCCURRED WITH TWO OTHER SUTURES. A NEW SUTURE FROM THE SAME BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20307199 ↗MalfunctionSep 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHILE SUTURING THE FASCIA, AFTER INSERTING THE NEEDLE INTO THE TISSUE AND MAKING ONE TO TWO STITCHES, THE NEEDLE SEPARATED FROM THE THREAD. IT WAS IMPOSSIBLE TO COMPLETE THE SUTURING WITH THE THREAD. THE SAME ISSUE OCCURRED WITH THREE OTHER SUTURES. A NEW SUTURE FROM THE SAME BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20298017 ↗MalfunctionSep 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHILE SUTURING THE FASCIA, AFTER INSERTING THE NEEDLE INTO THE TISSUE AND MAKING ONE TO TWO STITCHES, THE NEEDLE SEPARATED FROM THE THREAD. IT WAS IMPOSSIBLE TO COMPLETE THE SUTURING WITH THE THREAD. THE SAME ISSUE OCCURRED WITH TWO OTHER SUTURES. A NEW SUTURE FROM THE SAME BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20298016 ↗MalfunctionSep 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A WHILE SUTURING THE FASCIA, WHILE SUTURING, AFTER INSERTING THE NEEDLE INTO THE TISSUE AND MAKING ONE TO TWO STITCHES, THE NEEDLE SEPARATED FROM THE THREAD FOR ALL 3 DEVICE. IT WAS IMPOSSIBLE TO COMPLETE THE SEWING WITH THE THREAD. THE SAME ISSUE OCCURRED WITH THE OTHER TWO SUTURES. A NEW SUTURE FROM THE SAME BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20298009 ↗
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.