Polysorb GL-224Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521045163), received between Jan 12, 2018 and Jan 16, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MYOMECTOMY PROCEDURE, TWO DEVICES SUTURE WERE BROKEN. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18523254 ↗
• MalfunctionJan 16, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MYOMECTOMY PROCEDURE, TWO DEVICES SUTURE WERE BROKEN. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18523234 ↗
• MalfunctionOct 13, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PREOPERATIVELY, TWO NEEDLES WERE IN A SHUTTLE THAT SHOULD ONLY CONTAIN ONE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936590 ↗
• MalfunctionFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVE TO ROUTINE VETERINARY OVARIECTOMY WHERE SUTURE WAS USED TO LIGATE BOTH OVARIAN PEDICLES AND CRANIAL UTERINE HORNS, THE LABRADOR DEVELOPED A SEPTIC PERITONITIS AND AN EXPLORATORY LAPAROTOMY WAS PERFORMED FOUR DAYS AFTER THE INITIAL SURGERY DUE TO CLINICAL DETERIORATION. SIGNIFICANT TISSUE ADHESIONS WERE PRESENT AND BLUNT DISSECTION RESULTED IN SIGNIFICANT TRAUMA TO THE DISTAL AORTA/PROXIMAL RIGHT ILIAC ARTERY, RESULTING IN PATIENT HAVING POST-THROMBOTIC SYNDROME ON THE TABLE. THE FOCUS OF SUPPURATIVE INFLAMMATORY REACTIONS APPEARED TO BE AT BOTH OVARIAN PEDICLES AND IN THE DISTAL RIGHT INGUINAL AREA. ANOTHER SUTURE WAS UTILIZED FOR LINEA ALBA ABDOMINAL WALL CLOSURE (NO REACTION). ABDOMINAL FLUID SAMPLES OBTAINED AT EXPLORATORY LAPAROTOMY CONFIRMED BACTERIAL INFECTION. POST-MORTEM FAILED TO IDENTIFY ANY OTHER CAUSE OTHER THAN IATROGENIC BREAK IN ASEPSIS DURING NEUTERING.

  Patient problems: Adhesion(s); Bacterial Infection; Peritonitis; Thrombosis/Thrombus

  MAUDE report 16431570 ↗
• InjuryJun 23, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A DEEP SUTURE ON AN INGUINAL HERNIA REPAIR, THE NEEDLE BROKE IN THE TISSUES AND THE BROKEN PIECE FELL INTO THE PATIENT¿S CAVITY.

  Patient problems: Device Embedded In Tissue or Plaque; No Information; Tissue Damage

  MAUDE report 8725659 ↗
• MalfunctionDec 2, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING FASCIA CLOSURE, THE NEEDLE BROKE. THE SURGEON REALIZED THAT THE NEEDLE WAS BROKEN AT ITS END AFTER THE COMPLETION OF THE 2ND POINT. A PIECE OF THE NEEDLE WAS AT THE OPERATIVE SITE. REMOVING THE NEEDLE PIECE FROM THE SURGICAL SITE AND USING ANOTHER WIRE FOR THE REST OF THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8123165 ↗
• MalfunctionSep 7, 2018Break; Break

  ACCORDING TO THE REPORTER, THE NEEDLE TIP SNAPPED OFF DURING A PROCEDURE. THEY FOUND IT ON THE DRAPE AND DISCARDED SAFELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7855593 ↗
• MalfunctionMay 22, 2018Bent; Break; Detachment Of Device Component; Bent; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SUTURE NEEDLE BENDS EASILY AND IT BROKE. A PORTION OF THE SUTURE NEEDLE FELL INTO THE PATIENT CAVITY AND THEY WERE ABLE TO COMPLETELY RETRIEVE THE BROKEN PIECE FROM THE PATIENT¿S CAVITY. THEY NOTED THAT THIS EVENT RESULTED IN SIGNIFICANT TIME LOSS AND IT MADE IT HARDER TO COMPLETE THE SUTURING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7533093 ↗
• MalfunctionJan 12, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING ON C-SECTION PROCEDURE, THE DEVICE'S NEEDLE AND THREAD WAS BROKE. NO PATIENT INJURY HAS BEEN NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7187471 ↗

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