Polysorb SL-692Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521049222), received between Jun 21, 2018 and Apr 21, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Break

  ACCORDING TO THE REPORTER, WHILE PREPARING FOR SURGICAL SUTURING, THE SUTURE BROKE IMMEDIATELY UPON TENSION. IT WAS PROMPTLY REPLACED, AND NO ADVERSE IMPACT ON THE PROCEDURE OCCURRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942042 ↗
• MalfunctionMar 12, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN CESAREAN SECTION AND GYNECOLOGICAL SURGERY, ON SKIN SUTURING, THE FOUR SUTURES DETACHED FROM THE NEEDLES AT THE CONNECTION POINT. A NEW SUTURE WAS USED TO RESOLVE THE  ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24580919 ↗
• MalfunctionFeb 13, 2026Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A DENTAL IMPLANT SURGERY DUE TO MISSING TEETH, DURING WOUND CLOSURE, THE SUTURE SUDDENLY DETACHED FROM THE NEEDLE. THE DOCTOR DISCOVERED A CRACK AT THE EYE OF THE SUTURE NEEDLE. AFTER CONFIRMING THAT NO SUTURE NEEDLE FRAGMENTS REMAINED IN THE PATIENT'S ORAL CAVITY, A NEW SUTURE WAS OPENED AND USED TO COMPLETE THE CLOSURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330203 ↗
• MalfunctionApr 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER OPENING THE CONSUMABLES PACKAGE, IT WAS FOUND THAT THE SUTURE WAS BROKEN. THE SUTURE WAS REPLACED FOR SUTURING. NO OBVIOUS HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919230 ↗
• MalfunctionDec 11, 2024Break; Break

  ACCORDING TO THE REPORTER, A CESAREAN SECTION WAS PERFORMED UNDER COMBINED SPINAL-EPIDURAL ANESTHESIA. THE OPERATION WAS ABOUT TO END, AND THE SKIN WAS CLOSED WITH SYNTHETIC ABSORBABLE SUTURES (4-0). AFTER THE ASSISTANT SEWED A FEW STITCHES, THE NEEDLE THREAD BROKE AT THE TAIL END OF THE NEEDLE, CAUSING BLEEDING AT THE SUTURE POINT. THE AMOUNT OF BLEEDING INCREASED, INCREASING THE RISK OF INFECTION. THE CIRCULATING NURSE PROMPTLY REPLACED THE SUTURE WITH THE SAME TYPE AND MODEL AND CONTINUED THE SUTURING. THE OPERATION WAS SUCCESSFULLY COMPLETED, AND THE MATERNAL VITAL SIGNS WERE SMOOTHLY SENT BACK TO THE WARD.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20902965 ↗
• MalfunctionNov 28, 2024Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE THREAD WAS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 20805473 ↗
• MalfunctionNov 27, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CESAREAN SECTION SKIN SUTURE PROCEDURE, THE THREAD WAS BROKEN. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800166 ↗
• MalfunctionNov 20, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE UNPACKING, THE SKIN SUTURE HAD NOT BEEN STARTED, AND THE NEEDLE AND THREAD WERE FOUND DETACHED, WITH THE THREAD ALSO BREAKING.

  Patient problems: Insufficient Information

  MAUDE report 20740695 ↗
• MalfunctionNov 4, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POSTOPERATIVELY OF THE CESAREAN SECTION, IT WAS NOTED THAT DURING THE INITIAL PROCEDURE, THE SKIN WAS SUTURED WITH ABSORBABLE SUTURE, AND AFTER SUTURING, THE SKIN WAS INTACT WITHOUT THREAD ENDS. THE INITIAL OPERATION WAS SUCCESSFULLY COMPLETED. MOREOVER, 164 DAYS AFTER DISCHARGE, THE ABSORBABLE SUTURE WAS NOT ABSORBED AND THE SUTURE WAS VISIBLE ON THE SKIN, INCREASING THE PATIENT'S PSYCHOLOGICAL BURDEN AND WOUND PAIN. HENCE, AFTER A FOLLOW-UP, THE SURGEON ASKED TO OBSERVE AND WAIT FOR THE SUTURE TO FALL OFF ON ITS OWN.

  Patient problems: Pain

  MAUDE report 20597853 ↗
• MalfunctionSep 4, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC DOUBLE HYSTERECTOMY, DOUBLE FALLOPIAN TUBE RESECTION, VAGINAL STUMP SUSPENSION, PELVIC ADHESION LYSIS, INTESTINAL ADHESION LYSIS, AND DRAINAGE PROCEDURE, AT THE TIME OF OPENING THE PACKAGING AND COUNTING THE SUTURES, IT WAS FOUND OUT THAT THE PACKAGING HAD TWO NEEDLES INSTEAD OF ONE. THE USER KEPT A GOOD RECORD OF THE NUMBER OF NEEDLES AND CONTINUED USING THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135390 ↗
• MalfunctionMar 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT OVARIAN CYST REMOVAL, RIGHT OVARIAN CYSTECTOMY AND PELVIC ADHESIONS RELEASE UNDER GENERAL ANESTHESIA, AT THE END OF THE SURGICAL PROCEDURE AND BEFORE STARTED USING IT, THE CONNECTION BETWEEN THE SUTURE AND THE NEEDLE WERE DISCONNECTED DURING CLAMPING AND COULD NOT USE IT. IT WAS NOTED THAT THE SURGERY TIME WAS EXTENDED BY 1 MINUTE. A NEW ABSORBABLE SUTURE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 18882603 ↗
• MalfunctionOct 19, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PELVIC ADHESION LYSIS WITH DOUBLE FALLOPIAN TUBE TRANSFUSION OF MEILAN, INTUBATION AND FIMBRIA-END PLUS STOMA, REMOVAL OF DOUBLE MESOSALPINX CYSTS, ELECTROCOAGULATION OF PELVIC ECTOPIC LESIONS, HYSTEROSCOPY, AND CURET TAGE, WHEN SUTURING USING THE 4-0 ABSORBABLE SUTURE IN THE ABDOMINAL INCISION, THE SUTURE BROKE. IT WAS NOTED THAT THE SURGERY TIME WAS EXTENDED BY LESS THAN 30 MINUTES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17968131 ↗
• MalfunctionDec 19, 2022Break; Break

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC PELVIC TUMOR RESECTION WITH LYSIS OF PELVIS AND INTESTINAL ADHESIONS, WHILE USING INTERRUPTED SUTURING TECHNIQUE, THE ABSORBABLE SURGICAL SUTURE AUTOMATICALLY BROKE WHEN SUTURING THE UMBILICAL INCISION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16010507 ↗
• MalfunctionNov 18, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AFTER OPENING THE PACKAGE, THE SUTURE THREAD BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12836632 ↗
• MalfunctionAug 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE IN CESAREAN SECTION, UPON SUTURING TISSUE, THE SUTURE AND THE NEEDLE WERE FOUND DETACHED THAT THE NEEDLE FELL INTO THE PATIENT'S CAVITY. THE HAND-WASHING NURSE TOOK THE NEEDLE AND THREADED THE SUTURE. THE SUTURING TIME WAS INCREASED AND LED TO A PROLONGED OPERATION TIME. IT WAS ALSO REPORTED THAT LAPAROSCOPIC PROCEDURE WAS CONVERTED TO OPEN BUT UNRELATED TO DEVICE PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10470436 ↗
• MalfunctionJun 21, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE CESAREAN SECTION SURGERY, IT WAS FOUND THAT THE NEEDLE AND THREAD WAS BROKEN WHEN USING SUTURE. ANOTHER SUTURE WAS OPENED TO COMPLETE THE OPERATION. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7625821 ↗

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