Polysorb L-1742KRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10884521046245), received between Sep 7, 2018 and Oct 17, 2025 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Break” (27 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE OPERATION, THE SUTURE BROKE EASILY WITH GENTLE TRACTION. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE, AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23320358 ↗
• MalfunctionAug 6, 2025Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT DURING AN OPEN EYE SURGERY, THE SUTURE EXHIBITED BOTH BREAKAGE AND SURFACE ROUGHNESS. ALTHOUGH THE SUTURE HAD NOT YET BEEN USED ON A PATIENT, THE ISSUE WAS IDENTIFIED UPON INSPECTION. THE DEFECTIVE SUTURE WAS IMMEDIATELY REPLACED WITH A NEW BOX OF THE SAME PRODUCT MODEL BUT A DIFFERENT LOT NUMBER, ALLOWING THE PROCEDURE TO CONTINUE WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731681 ↗
• MalfunctionJul 24, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PACKAGE WAS OPENED PRIOR THE OPHTHALMIC SURGERY, AND THE SUTURE BODY BROKE AS SOON AS IT WAS PULLED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585790 ↗
• MalfunctionJul 24, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PACKAGE WAS OPENED PRIOR THE OPHTHALMIC SURGERY, AND THE SUTURE BODY BROKE AS SOON AS IT WAS PULLED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585762 ↗
• MalfunctionJul 24, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PACKAGE WAS OPENED PRIOR THE OPHTHALMIC SURGERY, AND THE SUTURE BODY BROKE AS SOON AS IT WAS PULLED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585740 ↗
• MalfunctionJul 24, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PACKAGE WAS OPENED PRIOR THE OPHTHALMIC SURGERY, AND THE SUTURE BODY BROKE AS SOON AS IT WAS PULLED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585706 ↗
• MalfunctionJul 24, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PACKAGE WAS OPENED PRIOR THE OPHTHALMIC SURGERY, AND THE SUTURE BODY BROKE AS SOON AS IT WAS PULLED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585699 ↗
• MalfunctionJul 24, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PACKAGE WAS OPENED PRIOR THE OPHTHALMIC SURGERY, AND THE SUTURE BODY BROKE AS SOON AS IT WAS PULLED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585690 ↗
• MalfunctionJul 24, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PACKAGE WAS OPENED PRIOR THE OPHTHALMIC SURGERY, AND THE SUTURE BODY BROKE AS SOON AS IT WAS PULLED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585653 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY, THE SUTURE BROKE WHEN IT WAS TAKEN OUT OF THE PACKAGE AND ABOUT TO BE SUTURED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561131 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A STRABISMUS CORRECTION SURGERY, THE SUTURE BROKE WHEN IT WAS TAKEN OUT OF THE PACKAGE AND ABOUT TO BE SUTURED. THE ISSUE WAS RESOLVED BY REPLACING THE SUTURE WITH ONE FROM A DIFFERENT BATCH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22559438 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SUTURE THREAD BROKE ABNORMALLY WHEN IT WAS TAKEN OUT OF THE PACKAGE AND ABOUT TO BE USED FOR SUTURING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22558687 ↗
• MalfunctionJul 21, 2025Break; Break

  ACCORDING TO THE REPORTER, THE THREAD OF THE DEVICE BROKE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555228 ↗
• MalfunctionJul 18, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN STRABISMUS CORRECTION PROCEDURE, WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE, THE SUTURE BROKE. THIS ISSUE OCCURRED ON MORE THAN ONE DEVICE. TO RESOLVE THE ISSUE, A SAME TYPE OF SUTURE WITH A DIFFERENT LOT NUMBER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22549008 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A STRABISMUS CORRECTION SURGERY, THE SUTURE BROKE WHEN IT WAS TAKEN OUT OF THE PACKAGE AND ABOUT TO BE SUTURED. THE ISSUE WAS RESOLVED BY REPLACING THE SUTURE WITH ONE FROM A DIFFERENT BATCH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22548916 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A STRABISMUS CORRECTION SURGERY, THE SUTURE BROKE WHEN IT WAS TAKEN OUT OF THE PACKAGE AND ABOUT TO BE SUTURED. THE ISSUE WAS RESOLVED BY REPLACING THE SUTURE WITH ONE FROM A DIFFERENT BATCH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22548768 ↗
• MalfunctionMar 7, 2025Break; Break

  IT WAS REPORTED THAT DURING STRABISMUS SURGERY INVOLVING THE POLYSORB SUTURES, AFTER THE NEEDLE WAS PASSED THROUGH THE TISSUES AND AT THE MOMENT OF CREATING A KNOT, THE SUTURE BROKE ON THE MIDDLE PART. ANOTHER SUTURES FROM DIFFERENT LOT NUMBERS WERE USED BUT THE SAME ISSUE OCCURRED. A 5/0 USP SUTURE WAS USED IN PLACE OF THE 6/0, AND NO FURTHER ISSUES OCCURRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21545651 ↗
• MalfunctionMar 7, 2025Break; Break

  IT WAS REPORTED THAT DURING STRABISMUS SURGERY INVOLVING THE POLYSORB SUTURES, AFTER THE NEEDLE WAS PASSED THROUGH THE TISSUES AND AT THE MOMENT OF CREATING A KNOT, THE SUTURE BROKE ON THE MIDDLE PART. ANOTHER SUTURES FROM DIFFERENT LOT NUMBERS WERE USED BUT THE SAME ISSUE OCCURRED. A 5/0 USP SUTURE WAS USED IN PLACE OF THE 6/0, AND NO FURTHER ISSUES OCCURRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21545495 ↗
• MalfunctionJan 8, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN OPHTHALMIC PROCEDURE, IN OCULAR OBLIQUE STITCHING WHILE EMPLOYING A CONTINUOUS SUTURING TE CHNIQUE, THE THREAD BROKE FOR THE TWO SUTURES. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106838 ↗
• MalfunctionJan 8, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN OPHTHALMIC PROCEDURE, IN OCULAR OBLIQUE STITCHING WHILE EMPLOYING A CONTINUOUS SUTURING TE CHNIQUE, THE THREAD BROKE FOR THE TWO SUTURES. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106673 ↗
• MalfunctionAug 8, 2024Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, DURING PREPARATION, WHEN THE PACKAGING WAS OPENED, IT WAS FOUND THAT THE SUTURES INSIDE WERE BROKEN. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937402 ↗
• MalfunctionFeb 6, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHILE USING THE CONTINUOUS SUTURING TECHNIQUE, THE THREAD SNAPPED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 18655803 ↗
• MalfunctionMay 20, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN REPAIR OF TRADISMUS PROCEDURE, AT THE BEGGING OF THE SURGERY, WHEN THE SURGEON OPENED THE SUTURE PACKAGE THEY FOUND OUT THAT THE DEVICE THREAD WAS BROKEN/TORN, ANOTHER PACKAGE WAS OPEN HOWEVER SAME ISSUE WAS OCCURRED. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10075775 ↗
• MalfunctionApr 22, 2020Component Missing; Component Missing

  ACCORDING TO THE REPORTER, WHEN USING THE PRODUCT IN STRABISMUS PROCEDURE, THE SCRUB NURSE NOTED THAT THERE WAS NO CONTENTS IN PACKET. ANOTHER PACKET WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9989008 ↗
• MalfunctionFeb 13, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING STRABISMUS REPAIR, 5 THREADS BROKE WHILE TYING THE SUTURE THROUGH MUSCLE. ANOTHER SUTURE FROM COMPETITOR WAS USED TO COMPLETE THE CASE. SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE REPORTED CONDITION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9707093 ↗

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 · Terminated
  Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
• Z-2541-2017 · May 3, 2017 · Terminated
  Sutures. 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