Polysorb GL-34-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10884521045316), received between Sep 25, 2017 and May 4, 2026 — classified as 6 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT DURING A MODIFIED RADICAL MASTECTOMY OF THE LEFT BREAST, IN INCISION CLOSURE, THE THREAD BROKE DURING KNOT TYING EVEN WITH SLIGHT MANUAL TRACTION. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071513 ↗
• MalfunctionApr 23, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, TWO SURGEONS WERE SIMULTANEOUSLY PERFORMING SUTURING AT DIFFERENT LAPAROSCOPIC TROCAR SITES WHEN BOTH SUTURES FROM THE SAME PACKAGE BROKE. IT WAS NOTED THAT THE SURGEONS STRICTLY ADHERED TO STANDARD OPERATING PROCEDURES THROUGHOUT THE PROCEDURE, WITH NO EXCESSIVE FORCE, VIOLENT SUTURING, OR OVER-TENSIONING WAS INVOLVED. ANOTHER BRAND OF SUTURE WERE IMMEDIATELY REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24969437 ↗
• MalfunctionApr 23, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, TWO SURGEONS WERE SIMULTANEOUSLY PERFORMING SUTURING AT DIFFERENT LAPAROSCOPIC TROCAR SITES WHEN BOTH SUTURES FROM THE SAME PACKAGE BROKE. IT WAS NOTED THAT THE SURGEONS STRICTLY ADHERED TO STANDARD OPERATING PROCEDURES THROUGHOUT THE PROCEDURE, WITH NO EXCESSIVE FORCE, VIOLENT SUTURING, OR OVER-TENSIONING WAS INVOLVED. ANOTHER BRAND OF SUTURE WERE IMMEDIATELY REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24969101 ↗
• MalfunctionApr 6, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL RESECTION FOR COLON CANCER, THE NEEDLE TIP FRACTURED. THE SURGEON REPLACED THE DEVICE WITH ANOTHER MANUFACTURER¿S SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793690 ↗
• MalfunctionApr 6, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL COLECTOMY, WHILE SUTURING THE ENTERO-ENTERIC ANASTOMOSIS, THE NEEDLE TIP FRACTURED AS IT PASSED THROUGH THE TISSUE. THE USER OPENED A NEW SUTURE PACKET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789555 ↗
• MalfunctionOct 31, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A SMALL BOWEL RESECTION PROCEDURE, THE TAIL OF THE NEEDLE BROKE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23444432 ↗
• MalfunctionOct 29, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN SUBTOTAL GASTRECTOMY, THE NEEDLE BROKE WHILE SUTURING THE ANASTOMOSIS. ONLY ONE NEEDLE TIP REMAINED ON THE NEEDLE HOLDER. THE BROKEN NEEDLE WAS ACTIVELY SEARCHED FOR AND WAS SUCCESSFULLY FOUND. IT WAS NOTED THAT A SECONDARY PUNCTURE WAS NEEDED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 23420786 ↗
• MalfunctionDec 27, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PROCEDURAL/DEVICE-RELATED ISSUE OCCURRED WHEN AN OPERATING ROOM NURSE OPENED THE PACKAGE OF A SUTURE AND FOUND 6 SUTURES INSIDE. THE SUTURE WAS NOT TREATED OR HYDRATED PRIOR TO USE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 21027928 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY OF A LAPAROSCOPIC GASTRIC MALIGNANT TUMOR SURGERY, THE PATIENT'S GENERAL CONDITION WAS GOOD AFTER SURGERY AND THE ADVERSE EVENT WAS NOT DEVICE RELATED. AFTER THE PATIENT MOVED, THE ABDOMINAL DRAINAGE DRAINED BLOODY FLUID, AND THE AMOUNT OF DRAINAGE FLUID INCREASED SIGNIFICANTLY. THE HEMOGLOBIN OF THE BLOOD ROUTINE EXAMINATION CONTINUED TO DECREASE. ALSO, THE ABDOMINAL CT SCAN SHOWED PERITONEAL HEMORRHAGE, AND DELAYED ABDOMINAL HEMORRHAGE WAS CONSIDERED. IT WAS ALSO REPORTED THAT THE LAPAROSCOPIC PERITONEAL HEMORRHAGE REMOVAL WAS PERFORMED UNDER GENERAL ANESTHESIA FROM (B)(6) 2024 19:35 TO (B)(6) 2024: 40; ABDOMINAL HEMOSTASIS AFTER RECENT LAPAROTOMY. DURING THE PROCEDURE, BLOOD CLOTS AND FREE BLOOD ACCUMULATION WERE FOUND IN THE ABDOMINAL AND PELVIC CAVITIES, WITH A TOTAL AMOUNT OF ABOUT 500ML. THE BLOOD CLOTS WERE MAINLY LOCATED IN THE LEFT UPPER ABDOMEN AND PELVIC CAVITY, AND DARK RED BLOOD AND A SMALL AMOUNT OF BLOOD CLOTS WERE SEEN AROUND THE SPLEEN. THE MESANGIAL TEAR WAS SEEN AT THE WOUND EDGE OF THE MESANGIAL FISSURE SUTURE, WITH LOCAL BLOOD OOZING AND OBVIOUS TISSUE EDEMA.

  Patient problems: Extravasation; Hematoma; Hemorrhage/Blood Loss/Bleeding; Low Oxygen Saturation; Swelling/ Edema

  MAUDE report 20613277 ↗
• MalfunctionOct 10, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A PARTIAL GASTRECTOMY, DURING REINFORCEMENT AFTER GASTROINTESTINAL ANASTOMOSIS, THERE WERE ONLY FOUR NEEDLES AFTER THE PACKAGE WAS OPENED. THE SUTURE WAS NOT USED. A NEW SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20419104 ↗
• MalfunctionAug 22, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INTESTINAL ANASTOMOSIS, THE TIP OF THE NEEDLE WAS BROKEN. THE BROKEN TIP WAS FOUND BY USING A SUCTION. A NEW SUTURE FROM THE SAME BATCH WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20037401 ↗
• MalfunctionJun 4, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE SURGERY ON THE BODY AND TAIL OF THE PANCREAS, WHEN THE PANCREATIC STUMP WAS FINALLY PROCESSED, ONE NEEDLE AND ONE THREAD OF INTERRUPTED SUTURING WERE USED TO BRING THE RESECTION EDGES TOGETHER, THEN THE NEEDLE TIP SUDDENLY BOUNCED OFF. THE CIRCULATING AND SCRUB TEACHERS AND DOCTOR IMMEDIATELY FOUND THE NEEDLE TIP IN TIME WITHOUT ANY IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19460389 ↗
• InjuryMay 24, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTROINTESTINAL PROCEDURE, WHEN THE DOCTOR WAS USING SUTURES FOR SUTURING, THREE SUTURES WERE USED AND ALL THE NEEDLES BROKE. ONE OF THE NEEDLES BROKE IN THE ABDOMINAL CAVITY, AND THE SURGEON USED A C-ARM TO SEARCH FOR THE BROKEN NEEDLE, WHICH EXTENDED THE OPERATION TIME 2 HOURS. A COMPETITOR DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 19397961 ↗
• InjuryApr 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTROINTESTINAL SURGERY, ON INTESTINAL ANASTOMOSIS, THE TWO NEEDLES BROKE AND FELL INTO THE CAVITY OF THE PATIENT. A C-SHAPE ARM WAS USED TO SEARCH FOR THE BROKEN NEEDLE, WHICH EXTENDED THE SURGERY TIME BY TWO HOURS. ALSO, AN X-RAY WAS PERFORMED ON (B)(6) 2024 TO LOCATE THE COMPONENT. THE SURGEON USED ANOTHER SET OF NEEDLES FROM ANOTHER MANUFACTURER TO COMPLETE THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19127628 ↗
• InjuryApr 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTROINTESTINAL SURGERY, ON INTESTINAL ANASTOMOSIS, THE TWO NEEDLES BROKE AND FELL INTO THE THE CAVITY OF THE PATIENT. A C-SHAPE ARM WAS USED TO SEARCH FOR THE BROKEN NEEDLE, WHICH EXTENDED THE SURGERY TIME BY TWO HOURS. ALSO, AN X-RAY WAS PERFORMED ON (B)(6) 2024 TO LOCATE THE COMPONENT. THE SURGEON USED ANOTHER SET OF NEEDLES FROM ANOTHER MANUFACTURER TO COMPLETE THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19127387 ↗
• InjuryDec 29, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A GASTRIC STROMAL TUMOR PROCEDURE, IN THE REMOVAL OF MOST OF THE STOMACH, RESECTION OF PANCREATIC HEAD, AND SPLEEN, THE NEEDLE BROKE. IMMEDIATE ABDOMINAL EXPLORATION AND INTRAOPERATIVE FLUOROSCOPY WERE DONE, BUT THE NEEDLE TIP COULD NOT BE FOUND.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 18419578 ↗
• MalfunctionDec 8, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ENDOSCOPIC HEPATECTOMY, THE NEEDLE OF THE THREE SUTURES BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY AT LEAST THIRTY MINUTES AS A RESULT OF THE EVENT. THERE WAS NO DEVICE COMPONENT THAT FELL INTO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18295034 ↗
• MalfunctionDec 8, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ENDOSCOPIC HEPATECTOMY, THE NEEDLE OF THE THREE SUTURES BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY AT LEAST THIRTY MINUTES AS A RESULT OF THE EVENT. THERE WAS NO DEVICE COMPONENT THAT FELL INTO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18294835 ↗
• MalfunctionDec 8, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ENDOSCOPIC HEPATECTOMY, THE NEEDLE OF THE THREE SUTURES BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY AT LEAST THIRTY MINUTES AS A RESULT OF THE EVENT. THERE WAS NO DEVICE COMPONENT THAT FELL INTO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18294821 ↗
• MalfunctionOct 31, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A RADICAL GASTRECTOMY FOR GASTRIC CANCER, THE NEEDLE TIP WAS BROKEN. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18043783 ↗
• MalfunctionSep 26, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING THYROID TUMOR RESECTION, THE NEEDLE TIP BROKE WHEN SUTURING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821359 ↗
• InjurySep 15, 2023Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A GASTRIC STROMAL TUMOR SURGERY, WHEN SUTURING THE TAIL OF THE PANCREAS, IT WAS FOUND THAT THE TIP OF A NEEDLE WAS BROKEN BUT IT COULDN'T BE FOUND. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE DEVICE ISSUE. AN X-RAY WAS USED FOR THE EXPRESS PURPOSE OF LOCATING THE NEEDLE, OR CONFIRMING THAT ALL PIECES WERE LOCATED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 17760855 ↗
• MalfunctionMar 22, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING SKIN SUTURING OF THE WOUND, THE NEEDLE BROKE AND WAS TAKEN OUT WITH A NEEDLE HOLDER. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16593106 ↗
• MalfunctionDec 19, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING SURGERY, WHEN THE DOCTOR USED SUTURE, THE NURSE OPENED THE PACKAGE AND FOUND THAT THERE WERE 6 NEEDLES IN THE 5-NEEDLE PACKAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16006005 ↗
• MalfunctionMar 28, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING WOUND SUTURING, WHEN THE PACKAGE WAS OPENED, THERE WERE 6 NEEDLES IN THE PACKAGE INSTEAD OF JUST 5. THE DEVICE WAS REPLACED AND THE DEVICES WERE COUNTED AGAIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13928805 ↗

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