Polysorb CL-944Recalls & reported problems
Covidien LP · Braided Absorbable Suture · Class 2 · Implant
Quick summary
This Polysorb CL-944 is a Covidien braided absorbable surgical suture used to close tissue during surgery. The 49 reports mostly describe the needle coming loose from the suture strand or breaking, sometimes while being pulled from its packaging before surgery even begins; no reports describe harm to the patient, and there are no deaths or injuries. No recalls name this device. Reports have risen sharply, from 5 in the earlier 12-month period to 28 in the most recent one.
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
- 46
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10884521043602), received between Aug 8, 2017 and Apr 1, 2026 — classified as 46 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (44 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 Component44
- Break16
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- Insufficient Information6
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE NEEDLE HAS COME LOOSE FROM THE STRAND SEVERAL TIMES. AN ADDITIONAL NEW EQUIVALENT SUTURE WAS TAKEN OUT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24757725 ↗MalfunctionMar 24, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE NEEDLE HAS COME LOOSE FROM THE STRAND SEVERAL TIMES. AN ADDITIONAL NEW EQUIVALENT SUTURE WAS TAKEN OUT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24678342 ↗MalfunctionMar 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, NEEDLE DETACHMENT OCCURRED ON FOUR SUTURES WHILE SUTURING.
Patient problems: Insufficient Information
MAUDE report 24645862 ↗MalfunctionMar 18, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING A CESAREAN SECTION, WHEN CLOSING THE UTERUS, THE NEEDLE DETACHED FROM THE SUTURE THREAD. A DIFFERENT SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24635790 ↗MalfunctionMar 9, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE NEEDLE BROKE WHILE REMOVING THE NEEDLE SUTURE FROM THE PACKAGING. TWO SUTURES WERE USED AND HAD THE SAME ISSUE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24548227 ↗MalfunctionMar 4, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SUTURING, TWO NEEDLE DETACHMENTS OCCURRED. A NEW SUTURE FROM ANOTHER BOX WAS USED TO RESOLVE THE ISSUE. NO CONSEQUENCES OR IMPACT TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24513591 ↗MalfunctionMar 4, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE NEEDLE DETACHED FROM THE SUTURE. THE ISSUE OCCURRED WITH ABOUT TWO SUTURES FROM THE SAME BOX, AND THE SAME PROBLEM WAS OBSERVED. A NEW BOX WAS OPENED AND USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24513530 ↗MalfunctionMar 4, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SUTURING, TWO NEEDLE DETACHMENTS OCCURRED. A NEW SUTURE FROM ANOTHER BOX WAS USED TO RESOLVE THE ISSUE. NO CONSEQUENCES OR IMPACT TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24513236 ↗MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A CESAREAN SECTION, WHILE SUTURING AND PREPARING THE SUTURE AFTER THE PATIENT'S INCISION, THE NEEDLE DETACHED. IT WAS NOTED THAT THE TWO SUTURES WERE USED AND HAD THE SAME ISSUE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23874019 ↗MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A CESAREAN SECTION, WHILE SUTURING AND PREPARING THE SUTURE AFTER THE PATIENT'S INCISION, THE NEEDLE DETACHED. IT WAS NOTED THAT THE TWO SUTURES WERE USED AND HAD THE SAME ISSUE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23873975 ↗MalfunctionDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE NEEDLE DETACHED, BUT IT DID NOT FALL INTO THE PATIENT¿S CAVITY. THE SAME ISSUE OCCURRED ON TWO MORE SUTURES. A NEW SUTURE FROM A DIFFERENT DISTRIBUTOR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23851154 ↗MalfunctionDec 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE NEEDLE DETACHED, BUT IT DID NOT FALL INTO THE PATIENT¿S CAVITY. THE SAME ISSUE OCCURRED ON TWO MORE SUTURES. A NEW SUTURE FROM A DIFFERENT DISTRIBUTOR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828060 ↗MalfunctionDec 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE NEEDLE DETACHED, BUT IT DID NOT FALL INTO THE PATIENT¿S CAVITY. THE SAME ISSUE OCCURRED ON TWO MORE SUTURES. A NEW SUTURE FROM A DIFFERENT DISTRIBUTOR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827973 ↗MalfunctionDec 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A C-SECTION, WHILE SUTURING AND PREPARING THE SUTURE AFTER THE PATIENT'S INCISION, THE NEEDLE DETACHED. THE ISSUE AFFECTED TWO SUTURES FROM THE SAME PRODUCT AND LOT NUMBER. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23789530 ↗MalfunctionDec 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A C-SECTION, WHILE SUTURING AND PREPARING THE SUTURE AFTER THE PATIENT'S INCISION, THE NEEDLE DETACHED. THE ISSUE AFFECTED TWO SUTURES FROM THE SAME PRODUCT AND LOT NUMBER. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23789387 ↗MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED, BUT IT DID NOT FALL INTO THE PATIENT¿S CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23744321 ↗MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A SECTIO PERITONEO SUTURING, THE NEEDLE DETACHED, BUT IT DID NOT FALL INTO THE PATIENT¿S CAVITY. THE ISSUE OCCURRED ON THREE SUTURES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. THE PRODUCT WAS RETURNED WITHOUT ACCOMPANYING INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23743694 ↗MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A SECTIO PERITONEO SUTURING, THE NEEDLE DETACHED, BUT IT DID NOT FALL INTO THE PATIENT¿S CAVITY. THE ISSUE OCCURRED ON THREE SUTURES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. THE PRODUCT WAS RETURNED WITHOUT ACCOMPANYING INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23743638 ↗MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A SECTIO PERITONEO SUTURING, THE NEEDLE DETACHED, BUT IT DID NOT FALL INTO THE PATIENT¿S CAVITY. THE ISSUE OCCURRED ON THREE SUTURES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. THE PRODUCT WAS RETURNED WITHOUT ACCOMPANYING INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23743309 ↗MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED, BUT IT DID NOT FALL INTO THE PATIENT¿S CAVITY. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742741 ↗MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED, BUT IT DID NOT FALL INTO THE PATIENT¿S CAVITY. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742721 ↗MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED, BUT IT DID NOT FALL INTO THE PATIENT¿S CAVITY. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742642 ↗MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED, BUT IT DID NOT FALL INTO THE PATIENT¿S CAVITY. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742458 ↗MalfunctionNov 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE SUTURING, THE THREAD CAME LOOSE FROM THE NEEDLE. THE SURGEON TRIED ANOTHER SUTURE FROM THE SAME BATCH AND HAD THE SAME PROBLEM. THE NEEDLE DID NOT FALL FROM THE PATIENT CAVITY. ADDITIONAL NEW SUTURES FROM A DIFFERENT BATCH WERE USED WITHOUT ISSUE.
Patient problems: Insufficient Information
MAUDE report 23585951 ↗MalfunctionNov 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE SUTURING, THE THREAD CAME LOOSE FROM THE NEEDLE. THE SURGEON TRIED ANOTHER SUTURE FROM THE SAME BATCH AND HAD THE SAME PROBLEM. THE NEEDLE DID NOT FALL FROM THE PATIENT CAVITY. ADDITIONAL NEW SUTURES FROM A DIFFERENT BATCH WERE USED WITHOUT ISSUE.
Patient problems: Insufficient Information
MAUDE report 23585879 ↗
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
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- 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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.