Polysorb GL-33-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10884521045309), received between Jul 17, 2018 and Sep 21, 2026 — classified as 2 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (23 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.

• MalfunctionSep 21, 2026Break

  According to the reporter, during a procedure, after the surgeon completed the suturing, the needle tip was found to have broken when the needle holder withdrew the needle. The broken end was found on the table. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839273 ↗
• MalfunctionAug 26, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50459709 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY SURGERY, A BROKEN NEEDLE OCCURRED DURING SUTURING BUT DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED, AND THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454969 ↗
• MalfunctionNov 4, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THERE WERE 6 NEEDLES PRESENT INSTEAD OF THE EXPECTED 5 NEEDLES. ANOTHER LOT NUMBER PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464600 ↗
• MalfunctionSep 4, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF THE LEFT DISTAL RADIUS FRACTURE AND ARTIFICIAL BONE GRAFTING SURGERY UNDER GENERAL ANESTHESIA. ON THE SAME DAY, COATED BRAIDED SYNTHETIC ABSORBABLE SUTURES WERE USED TO SUTURE THE INCISION. DURING KNOTTING, THE SUTURES WERE FOUND TO BE PRONE TO BREAKING, MAKING SUTURING IMPOSSIBLE. THE DELAY IN SUTURING THE INCISION POSED AN INFECTION RISK, WORSENED THE PATIENT'S CONDITION, AND INCREASED DISCOMFORT. UPON IDENTIFYING THE ISSUE, THE DEFECTIVE SUTURES WERE IMMEDIATELY REPLACED WITH NORMAL COATED BRAIDED SYNTHETIC ABSORBABLE SUTURES TO COMPLETE INCISION CLOSURE.

  Patient problems: Discomfort

  MAUDE report 22962248 ↗
• MalfunctionJul 16, 2025Break; Break

  IT WAS REPORTED THAT THE SUTURE BROKE AFTER SUTURING ABOUT THREE SUTURES DURING A PROCEDURE USING THE INTERRUPTED SUTURE TECHNIQUE. THE THREAD WAS IDENTIFIED AS THE PART THAT BROKE. THE PRODUCT WAS REPLACED BY ANOTHER MANUFACTURER'S PRODUCT.

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

  MAUDE report 22517625 ↗
• MalfunctionMar 22, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RADICAL RESECTION OF ESOPHAGEAL CANCER WAS PERFORMED, A SUTURE WAS USED TO SUTURE THE GASTRIC TISSUE AFTER OPENING THE PACKAGE, IT WAS FOUND THAT ALL FIVE SUTURES AND NEEDLES WERE DETACHED, AND THE MIDDLE SECTION OF THE THREAD BROKE OFF AUTOMATICALLY AND COULD NOT BE USED. THEN ANOTHER PACKAGE OF SUTURE WAS OPENED, WHICH INCREASED THE PATIENT'S WAITING TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21672990 ↗
• MalfunctionMar 22, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RADICAL RESECTION OF ESOPHAGEAL CANCER WAS PERFORMED, A SUTURE WAS USED TO SUTURE THE GASTRIC TISSUE, AFTER OPENING THE PACKAGE, IT WAS FOUND THAT ALL FIVE SUTURES AND NEEDLES WERE DETACHED, AND THE MIDDLE SECTION OF THE THREAD BROKE OFF AUTOMATICALLY AND COULD NOT BE USED. THEN ANOTHER PACKAGE OF SUTURE WAS OPENED, WHICH INCREASED THE PATIENT'S WAITING TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21672989 ↗
• MalfunctionMar 22, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RADICAL RESECTION OF ESOPHAGEAL CANCER WAS PERFORMED, A SUTURE WAS USED TO SUTURE THE GASTRIC TISSUE, AFTER OPENING THE PACKAGE, IT WAS FOUND THAT ALL FIVE SUTURES AND NEEDLES WERE DETACHED, AND THE MIDDLE SECTION OF THE THREAD BROKE OFF AUTOMATICALLY AND COULD NOT BE USED. THEN ANOTHER PACKAGE OF SUTURE WAS OPENED, WHICH INCREASED THE PATIENT'S WAITING TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21672985 ↗
• MalfunctionMar 22, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RADICAL RESECTION OF ESOPHAGEAL CANCER WAS PERFORMED, A SUTURE WAS USED TO SUTURE THE GASTRIC TISSUE; AFTER OPENING THE PACKAGE, IT WAS FOUND THAT ALL FIVE SUTURES AND NEEDLES WERE DETACHED, AND THE MIDDLE SECTION OF THE THREAD BROKE OFF AUTOMATICALLY AND COULD NOT BE USED. THEN ANOTHER PACKAGE OF SUTURE WAS OPENED, WHICH INCREASED THE PATIENT'S WAITING TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21671317 ↗
• MalfunctionMar 22, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RADICAL RESECTION OF ESOPHAGEAL CANCER WAS PERFORMED, A SUTURE WAS USED TO SUTURE THE GASTRIC TISSUE; AFTER OPENING THE PACKAGE, IT WAS FOUND THAT ALL FIVE SUTURES AND NEEDLES WERE DETACHED, AND THE MIDDLE SECTION OF THE THREAD BROKE OFF AUTOMATICALLY AND COULD NOT BE USED. THEN ANOTHER PACKAGE OF SUTURE WAS OPENED, WHICH INCREASED THE PATIENT'S WAITING TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21671271 ↗
• MalfunctionNov 1, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BREAST SURGERY, AFTER OPENING THE PACKAGING, IT WAS FOUND THAT THE THREAD WAS BROKEN. THE SAME ISSUE OCCURRED WITH 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 20593104 ↗
• MalfunctionNov 1, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BREAST SURGERY, AFTER OPENING THE PACKAGING, IT WAS FOUND THAT THE THREAD WAS DETACHED FROM THE NEEDLE. THE SAME ISSUE OCCURRED WITH 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 20592538 ↗
• InjuryJun 26, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC RADICAL RESECTION OF RECTAL CANCER, AFTER SUTURING THE INCISION, AN EXAMINATION REVEALED THAT THE NEEDLE TIP WAS MISSING. INTRA-ABDOMINAL SEARCH WAS PERFORMED. THE FOREIGN MATTER REMAINING IN THE PATIENT LEAD TO INFECTION AND POOR HEALING. NO ACTIONS WERE TAKEN FOR REMEDIATION.

  Patient problems: Foreign Body In Patient; Impaired Healing; Unspecified Infection

  MAUDE report 19614187 ↗
• MalfunctionMar 6, 2024Break; Break

  ACCORDING TO THE REPORTER, IN AN OPEN HEMORRHOIDECTOMY, DURING SUTURING AFTER THE REMOVAL OF THE HEMORRHOIDS, THE POINT OF THE NEEDLE BROKE. A DIFFERENT SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18846189 ↗
• MalfunctionDec 1, 2023Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, DURING A RADICAL RESECTION OF RECTAL CANCER PROCEDURE, AFTER THE ABSORBABLE SUTURE WAS USED TO SUTURE THE INCISION AND KNOTTED, THE BLEEDING FROM THE PERINEAL INCISION DID NOT COMPLETELY STOP. THE PATIENT LOST 10CC BLOOD WHICH DID NOT REQUIRE A BLOOD TRANSFUSION. SUTURE SLIPPAGE OCCURRED AND THE KNOTS BECAME LOOSE. THE ABSORBABLE SUTURE WAS REMOVED AND WAS REPLACED WITH A BARBED SUTURE. THE PATIENT RECOVERED SMOOTHLY AND WAS DISCHARGED FROM THE HOSPITAL AFTER THE OPERATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18246351 ↗
• MalfunctionFeb 16, 2023Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE BROKE INTO TWO PIECES AND WAS RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16387114 ↗
• MalfunctionJan 17, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN HERNIA PROCEDURE, THE NEEDLE BROKE FROM SEVERAL SUTURES. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183360 ↗
• MalfunctionNov 10, 2022Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING OPEN GASTROINTESTINAL SURGERY WITH LAPAROSCOPIC COMBINED AUXILIARY INCISION, WHEN THE AUXILIARY INCISION WAS OPENED FOR ANASTOMOSIS, THREE NEEDLES FROM THE SAME PACK BROKE. THE TWO REMAINING SUTURES FROM THE PACK WERE USED TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 15772017 ↗
• MalfunctionOct 28, 2022Component Missing; Component Missing

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AFTER UNPACKING, IT WAS FOUND THAT THERE WERE 5 NEEDLES AND 1 NEEDLE WAS MISSING. A NEW SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15693895 ↗
• MalfunctionOct 3, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN GASTROINTESTINAL SURGERY WITH LAPAROSCOPIC COMBINED AUXILIARY INCISION, WHEN THE AUXILIARY INCISION WAS OPENED FOR ANASTOMOSIS, FIVE NEEDLES BROKE. ANOTHER SUTURE WAS USED TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15528925 ↗
• MalfunctionDec 7, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER PRE-OPERATIVELY, UPON OPENING THE BOX IT WAS FOUND THAT THERE WERE ONLY SEVEN PACKS IN THE BOX. IT WAS REPLACED WITH ANOTHER BOX TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953399 ↗
• MalfunctionAug 27, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN SENTINEL NODE DISSECTION, WHEN SUTURING, THE NEEDLE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12379366 ↗
• MalfunctionMay 5, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, WHEN PREPARING AND DISASSEMBLING THE SUPPLIES PRIOR A RADICAL RESECTION OF COLORECTAL CANCER, IT WAS FOUND THAT ONE NEEDLE AND THREAD WERE MISSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781107 ↗
• MalfunctionMar 15, 2021Detachment of Device or Device Component; Manufacturing, Packaging or Shipping Problem; Detachment of Device or Device Component; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN OPENING THE PACKAGING, THE PRODUCT HAD SIX NEEDLES AND SUTURES PARKED IN THE RETAINER. NORMALLY, IT HAD FIVE NEEDLES AND SUTURES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11490473 ↗

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