Polysorb GL-69-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10884521045477), received between Aug 31, 2017 and Sep 18, 2025 — classified as 11 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (11 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING AN OPEN IRRIGATION AND DEBRIDEMENT PROCEDURE FOR A RIGHT BREAST HEMATOMA, THE SUTURE LINE DID NOT HOLD, WITH KNOTS UNRAVELING MULTIPLE TIMES DURING CLOSURE BELOW THE SKIN. THE SURGEON TIED FIVE KNOTS, BUT THE KNOTS CONTINUED TO UNRAVEL. 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 23088664 ↗
• MalfunctionFeb 6, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A C4-5 ANTERIOR CERVICAL DECOMPRESSION AND FUSION WITH ALLOGRAFT OPEN PROCEDURE, WHILE SUTURING IN THE NECK, THE NEEDLE BROKE WHEN THE SURGEON GRABBED THE NEEDLE. ANOTHER STRAND WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18655994 ↗
• InjuryAug 11, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO A LUMBAR DECOMPRESSION LAMINECTOMY, THE SUTURE SEEMED TO DISSOLVE WITHIN A FEW WEEKS AND WAS 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 17515791 ↗
• InjuryAug 11, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO A LUMBAR MICRODISCECTOMY, THE SUTURE SEEMED TO DISSOLVE WITHIN A FEW WEEKS AND WAS 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 17515753 ↗
• InjuryAug 11, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO A LUMBAR MICRODISCECTOMY, 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 17515746 ↗
• InjuryAug 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO A CRANIOTOMY TUMOR WITH NAVIGATION, 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 17504349 ↗
• InjuryAug 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO A CRANIOTOMY TUMOR WITH NAVIGATION, 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 17504260 ↗
• 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 17503092 ↗
• 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 17502919 ↗
• InjuryAug 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO AN OPEN POSTERIOR SPINAL FUSION, 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 17500081 ↗
• InjuryAug 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO A LUMBAR DECOMPRESSION LAMINECTOMY, THE SUTURE SEEMED TO DISSOLVE WITHIN A FEW WEEKS AND WAS 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 17500040 ↗
• InjuryAug 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO A LUMBAR DECOMPRESSION LAMINECTOMY, THE SUTURE SEEMED TO DISSOLVE WITHIN A FEW WEEKS AND WAS 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 17500013 ↗
• InjuryAug 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO A LUMBAR MICRODISCECTOMY, 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 17499695 ↗
• MalfunctionApr 21, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A DECOMPRESSION OF THE SPINE, OPEN PROCEDURE, THE NEEDLE TIP BROKE OFF DURING CLOSURE OF SUBCUTANEOUS TISSUE. THE 2/3 OF THE NEEDLE BROKE OFF IN PATIENT AND 1/3 UPPER NEEDLE WAS ON THE NEEDLE DRIVERS. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16788589 ↗
• MalfunctionAug 30, 2022Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, DURING PROCEDURE, WHILE PERFORMING SEROSAL LEMBERT SUTURING, THE SUTURE WAS UNRAVELED. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 15324802 ↗
• MalfunctionAug 18, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE FELL APART.

  Patient problems: Insufficient Information

  MAUDE report 15249977 ↗
• MalfunctionAug 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE OF THE TWO SUTURES EASILY DETACHED FROM THE THREAD. ANOTHER SUTURE WAS USED TO CONTINUE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 15142801 ↗
• MalfunctionMay 25, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN VAGUS NERVE STIMULATION (VNS) REVISION, IN THE SUBDERMAL, THE TIP OF THE NEEDLE BROKE OFF. ALL PARTS WAS CONTAINED. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14498487 ↗
• MalfunctionMar 30, 2022Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING AN OPEN NEURO PROCEDURE, THE SURGEON SAID THAT THE NEEDLES WERE BENDING AND POPPING OFF PREMATURELY. TO RESOLVE THE ISSUE, MORE SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13952189 ↗
• MalfunctionJan 20, 2022Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 13311817 ↗
• MalfunctionJun 16, 2020Break; Break

  ACCORDING TO THE REPORTER, ALL SUTURES WERE USED TO SEW BOWEL. WHEN TWO NEEDLES WERE RECEIVED, IT WAS NOTICED THAT THE TIPS WERE MISSING.

  Patient problems: No Information

  MAUDE report 10157189 ↗
• MalfunctionJun 16, 2020Break; Break

  ACCORDING TO THE REPORTER, WHILE SUTURING DURING A PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF WHEN THE PHYSICIAN ASSISTANT WAS CLOSING THE PATIENT¿S SCALP. THE TIP WAS RECOVERED IN JAWS OF THE NEEDLE HOLDER.

  Patient problems: No Information

  MAUDE report 10156691 ↗
• MalfunctionJan 21, 2020Break; Break

  ACCORDING TO THE REPORTER, WHEN PERFORMING INTERRUPTED SUTURE TECHNIQUE DURING AN OPEN PROCEDURE, THE NEEDLE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9610701 ↗
• MalfunctionMay 29, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, WHEN THE SCRUB NURSE OPENED SUTURE PACK TO VERIFY THE NUMBERS OF NEEDLES PRE-OPERATIVELY, THE SCRUB NURSE FOUND ONLY 4 NEEDLES INSTEAD OF 5 AS LISTED. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8652566 ↗
• MalfunctionAug 31, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN MASTECTOMY PROCEDURE, THE DEVICE¿S NEEDLE BROKE 7MM FROM THE TIP. THE TECH FOUND THE NEEDLE PIECE OUTSIDE THE PATIENT. NOTHING FELL INTO THE PATIENT CAVITY. NO ADVERSE EVENTS WERE REPORTED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6837207 ↗

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