Polysorb GLS-122Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521045620), received between Jan 16, 2019 and Sep 9, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED THAT DURING A PACEMAKER INSERTION, TWO SUTURES WERE FOUND TO BE DEFECTIVE DURING THE SAME EVENT WITH THE SAME PATIENT, WITH ONE NEEDLE BREAKING AND ANOTHER NEEDLE DETACHING. 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 23001122 ↗
• MalfunctionApr 16, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LUMPECTOMY PROCEDURE, THE SUTURE BROKE WHILE SUTURING THE BREAST TISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21849784 ↗
• InjuryNov 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE SUTURING, THE NEEDLE TIP BROKE OFF IN THE PATIENT'S CAVITY. THE NEEDLE WAS ABLE TO BE RETRIEVED BY USING AN X-RAY TO LOCATE IT. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 20735659 ↗
• MalfunctionDec 4, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN EXCISION PILONIDAL CYST WITH COMPLEX REPAIR AND ADJACENT TISSUE TRANSFER, DURING SUTURE CLOSURE OF TISSUE, THE NEEDLE TIP BROKE AND DID NOT FALL IN CAVITY. DIFFERENT SUTURE OF THE SAME KIND WAS USED TO FINISH THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18263161 ↗
• MalfunctionJan 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE FELL OFF THE SUTURE WHILE IN THE ABDOMEN AND WAS LOCATED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306744 ↗
• MalfunctionDec 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC BI-LATERAL HERNIA, WHEN SUTURING THE MESH, THE OPERATOR GRABBED THE THREAD FOR THE 2ND SUTURE BEING USED, AND NOTICED THAT THERE WAS NO NEEDLE ON THE END THAT FELL RIGHT OFF THE SUTURE WHILE IN THE ABDOMEN.THE SURGEON WAS ABLE TO LOCATE THE NEEDLE IN THE ABDOMINAL WALL AND REMOVE IT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12910221 ↗
• MalfunctionJul 30, 2020Break; Break

  ACCORDING TO THE REPORTER, WHEN DOING ANASTOMOSIS INTRA-OPERATIVELY, SUTURE BROKE TWICE. AN ADDITIONAL NEW SUTURE USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10347486 ↗
• MalfunctionMar 30, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE THREAD BROKE UNDER VERY LITTLE TENSION. ANOTHER DEVICE FROM DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897296 ↗
• MalfunctionJan 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROUX-EN-Y PROCEDURE, NEEDLE DISENGAGED FROM THE SUTURE WHEN PLACED IN TROCAR. NEEDLE FELL ONTO THE TROCAR BUT WAS RETRIEVED IMMEDIATELY. NOTHING FELL INTO PATIENT'S CAVITY. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8253453 ↗

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