Polysorb GL-46-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521045354), received between May 23, 2018 and Jun 30, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Break

  ACCORDING TO THE REPORTER, DURING A GASTROINTESTINAL SURGERY, THE NEEDLE TIP OF THE SUTURE BEING USED BROKE. THE OPERATION WAS IMMEDIATELY PAUSED, AND THE SURGICAL FIELD WAS CAREFULLY EXPLORED. IT WAS NOTED THAT THE NEEDLE TIP DID NOT FALL INTO THE CAVITY. THE SUTURE WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673356 ↗
• MalfunctionMar 10, 2026Break

  ACCORDING TO THE REPORTER, DURING A OPEN THYROIDECTOMY, WHILE SUTURING THE THREAD BROKE. REUSING A PACK OF THE SAME TYPE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559026 ↗
• MalfunctionSep 26, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SUTURE WAS USED TO REINFORCE SUTURING AFTER CUTTING THE COLON, WHEN THE SUTURE ON THE NEEDLE BROKE, CAUSING TO REOPEN THE WOUND AND TISSUE BLEEDING. THE DOCTOR IMMEDIATELY REPLACED THE ABSORBABLE SUTURE, COMPLETED THE SUTURE REINFORCEMENT, AND THE PATIENT'S TISSUE STOPPED BLEEDING. THE PATIENT DID NOT HAVE HEAVY BLEEDING (LESS THAN 500 CC).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 20310282 ↗
• InjuryAug 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO A LUMBAR SPINE DECOMPRESSION, THE SUTURE SEEM TO DISSOLVE WITHIN A FEW WEEKS AND BREAKING DOWN BEFORE EXPECTED, WHICH HAS LED TO DEHISCENCE AND WOUND INFECTION. AS A RESPONSE TO THE SITUATION, INCISION AND DRAINAGE PROCEDURES WERE PERFORMED TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 17503041 ↗
• MalfunctionDec 15, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHEN SUTURING THE BILIARY TRACT, THE PACKAGE SHOWED 5 PIECES, BUT THERE WERE ACTUALLY 6 PIECES. THE SURGEON CONTINUED SUTURING TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13009636 ↗
• MalfunctionDec 8, 2021Component Missing; Component Missing

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS NO NEEDLE IN THE PACKAGE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12965460 ↗
• MalfunctionJul 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN THYROIDECTOMY PROCEDURE, THE SUTURE AND THE NEEDLE WERE FOUND DETACHED WHEN TAKING OUT FROM PACKAGE IT HAPPENED WITH 5 SUTURES. THE SURGEON THEN USED ANOTHER DEVICE 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 12182050 ↗
• MalfunctionJun 3, 2021Break; Break

  ACCORDING TO THE REPORTER, ON A LEFT PAROTID GLAND MASS AND PARTIAL SUPERFICIAL LOBECTOMY AND FACIAL NERVE DISSECTION, WHEN SUTURING THE MUSCLE TISSUE, THE NEEDLE TIP WAS FOUND TO BE BROKEN WHEN THE SKIN WAS SUTURED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930112 ↗
• MalfunctionFeb 5, 2021Break; Break

  ACCORDING TO THE REPORTER, THE SURGEON PERFORMED PYLORUS-PRESERVING PANCREATICODUODENECTOMY, AFTER THE PROCEDURE WAS USED, THE SCRUB NURSE WAS COUNTING THE NUMBERS OF THE NEEDLES. AT THE MOMENT, THE NURSE REALIZED THAT NEEDLE TIP WAS BROKEN OFF FROM THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11284438 ↗
• MalfunctionApr 9, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING HEMANGIOMA RESECTION OF THE LEFT UPPER ARM, THE PATIENT WOUND WAS SUTURE WITH THE DEVICE, HOWEVER THE NEEDLE BROKE THREE QUARTERS OF WHICH WERE UNDER THE INCISION AND ONE QUARTER WERE ON THE SUTURE LINE. AFTER FINDING THE BROKEN NEEDLE, THE DOCTOR FOUND THREE-QUARTERS OF THE BROKEN NEEDLE UNDER THE INCISION. AFTER TAKING IT OUT, THE DOCTOR CHECKED THE WHOLE NEEDLE WITH THE NURSE UNDER THE STAGE AND CONFIRMED THAT THE TWO BROKEN ENDS WERE A GOOD NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9943922 ↗
• MalfunctionJun 21, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A THYROIDECTOMY, TO CUT THE ISTHMUS OF THYROID GLAND NEEDED TO SUTURE IN THE PROCESS OF THYROIDECTOMY. THE NEEDLE HOLDER CLAMPED THE NEEDLE WHEN THE DOCTOR PULLED OUT THE NEEDLE. THE TOP OF NEEDLE WAS BROKEN AND FELL TO THE GROUND. THE NURSE NOTICED IT IN TIME AND REPLACED THE NEEDLE. THE OPERATION CONTINUED TO THE END. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7625789 ↗
• MalfunctionMay 23, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE THREAD WAS BROKE VERY EASILY WHEN KNOTTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7537272 ↗

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