Biosyn GM-324Recalls & reported problems
Covidien LP · Monofilament Absorbable Suture · Class 2 · Implant
Quick summary
This Covidien Biosyn GM-324 is an absorbable synthetic suture used to close wounds. The 46 reports mostly describe the needle coming loose from the thread or the suture breaking during use, which interrupted surgery and led to a new suture being opened; none report a death or an injury, and a few mention the wound reopening or tissue damage. No recalls name this device. Reports fell from 17 in the earlier 12 months to 6 in the most recent.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 20884521032719), received between Sep 27, 2017 and Feb 24, 2026 — classified as 46 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (27 reports).
28 other recalls cover devices cleared under the same FDA submission (K000037); 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component27
- Break18
- Adverse Event Without Identified Device or Use Problem3
- Unraveled Material3
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- Insufficient Information9
- No Known Impact Or Consequence To Patient7
- No Code Available4
- Organ Dehiscence2
- Tissue Damage2
- Wound Dehiscence2
- Death1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PEDIATRIC SURGERY, THE NEEDLE AND THREAD WERE DETACHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429786 ↗MalfunctionJan 12, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, WHILE SUTURING OR PREPARING SUTURE AFTER PATIENT INCISION, FIVE NEEDLES DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24047121 ↗MalfunctionJan 12, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, WHILE SUTURING OR PREPARING SUTURE AFTER PATIENT INCISION, FIVE NEEDLES DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24047062 ↗MalfunctionJan 12, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, WHILE SUTURING OR PREPARING SUTURE AFTER PATIENT INCISION, FIVE NEEDLES DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24047033 ↗MalfunctionJan 12, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, WHILE SUTURING OR PREPARING SUTURE AFTER PATIENT INCISION, FIVE NEEDLES DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24046972 ↗MalfunctionJan 12, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, WHILE SUTURING OR PREPARING SUTURE AFTER PATIENT INCISION, FIVE NEEDLES DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24046939 ↗MalfunctionSep 8, 2025Break; Break
IT WAS REPORTED THAT DURING INTRACUTANEOUS WOUND CLOSURE DURING APPLICATION AND SUTURING, THE SUTURE BROKE WITH AN UNUSUALLY FREQUENT OCCURRENCE OF SUTURE BREAKAGE OBSERVED DURING USE. THIS RESULTED IN SIGNIFICANT DISRUPTION TO THE WORKFLOW. A NEW SUTURE WAS SUBSEQUENTLY USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22997178 ↗MalfunctionSep 8, 2025Break; Break
IT WAS REPORTED THAT DURING INTRACUTANEOUS WOUND CLOSURE DURING APPLICATION AND SUTURING, THE SUTURE BROKE WITH AN UNUSUALLY FREQUENT OCCURRENCE OF SUTURE BREAKAGE OBSERVED DURING USE. THIS RESULTED IN SIGNIFICANT DISRUPTION TO THE WORKFLOW. A NEW SUTURE WAS SUBSEQUENTLY USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22997144 ↗MalfunctionAug 20, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, WHILE SUTURING, THE NEEDLE BROKE WHEN THE SURGEON TIGHTENED THE THREAD. THE BROKEN NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE THREAD WAS REMOVED, AND THE SURGEON USED A NEW NEEDLE TO START OVER. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22852932 ↗MalfunctionAug 20, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, WHILE SUTURING, THE NEEDLE BROKE WHEN THE SURGEON TIGHTENED THE THREAD. THE BROKEN NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE THREAD WAS REMOVED, AND THE SURGEON USED A NEW NEEDLE TO START OVER. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22852931 ↗MalfunctionAug 20, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, WHILE SUTURING, THE NEEDLE BROKE WHEN THE SURGEON TIGHTENED THE THREAD. THE BROKEN NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE THREAD WAS REMOVED, AND THE SURGEON USED A NEW NEEDLE TO START OVER. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22852886 ↗MalfunctionAug 20, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, WHILE SUTURING, THE NEEDLE BROKE WHEN THE SURGEON TIGHTENED THE THREAD. THE BROKEN NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE THREAD WAS REMOVED, AND THE SURGEON USED A NEW NEEDLE TO START OVER. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22852670 ↗MalfunctionAug 20, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, WHILE SUTURING, THE NEEDLE BROKE WHEN THE SURGEON TIGHTENED THE THREAD. THE BROKEN NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE THREAD WAS REMOVED, AND THE SURGEON USED A NEW NEEDLE TO START OVER. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22852580 ↗MalfunctionAug 20, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, WHILE SUTURING, THE NEEDLE BROKE WHEN THE SURGEON TIGHTENED THE THREAD. THE BROKEN NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE THREAD WAS REMOVED, AND THE SURGEON USED A NEW NEEDLE TO START OVER. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22852562 ↗MalfunctionJul 28, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, WHEN WITHDRAWING FROM THE RETAINER AND PREPARING FOR SUTURING, THE THREAD BROKE. THERE WERE FOUR SUTURES USED AND HAD THE SAME ISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22639774 ↗MalfunctionJul 28, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, WHEN WITHDRAWING FROM THE RETAINER AND PREPARING FOR SUTURING, THE THREAD BROKE. THERE WERE FOUR SUTURES USED AND HAD THE SAME ISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22638986 ↗MalfunctionJul 28, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, WHEN WITHDRAWING FROM THE RETAINER AND PREPARING FOR SUTURING, THE THREAD BROKE. THERE WERE FOUR SUTURES USED AND HAD THE SAME ISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22638919 ↗MalfunctionJul 28, 2025Break; Break
ACCORDING TO THE REPORTER DURING A VETERINARY PROCEDURE, WHEN WITHDRAWING FROM THE RETAINER AND PREPARING FOR SUTURING, THE THREAD BROKE. THERE WERE FOUR SUTURES USED AND HAD THE SAME ISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22628209 ↗MalfunctionJul 28, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE NEEDLE BROKE WHEN THE SURGEON TIGHTENED THE THREAD. THE BROKEN NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE THREAD WAS REMOVED, AND THE SURGEON USED A NEW NEEDLE TO START OVER. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22628133 ↗MalfunctionJul 16, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE NEEDLE HAD DETACHED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22519811 ↗MalfunctionJan 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE NEEDLE BREAKS FROM THE STRAND FOR MORE THAN ONE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21125891 ↗MalfunctionJan 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE NEEDLE BREAKS FROM THE STRAND FOR MORE THAN ONE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21125728 ↗MalfunctionNov 15, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A BREAST PROCEDURE, THE THREAD BROKE WHEN THE NEEDLE WAS PULLED OUT DURING DERMAL SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20694785 ↗MalfunctionMay 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN VETERINARY PROCEDURE, THE TWO THREADS WERE SEPARATED FROM THE NEEDLE. THE NEEDLE WAS STUCK IN THE NEEDLE DRIVER SUTURE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. NO DEVICE COMPONENT FELL INTO THE CAVITY OF THE PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19299799 ↗MalfunctionMar 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE SUTURE SEPARATED FROM THE NEEDLE. THE NEEDLE WAS STUCK IN THE NEEDLE DRIVER SUTURE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. NO DEVICE COMPONENT FELL INTO THE CAVITY OF THE PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18933187 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K000037. One submission often covers many models, so check the product and lot details in each record.
- Z-1290-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
- Z-1292-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, bu
- Z-1291-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but n
- Z-1280-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not i
- Z-1295-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in c
- Z-1294-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in c
- Z-1276-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
- Z-1281-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
- Z-1278-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
- Z-1299-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
- Z-1279-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but no
- Z-1277-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
- Z-1275-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
- Z-1282-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
- Z-1286-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
…and 13 more.
Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices
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- Coated VICRYL VCP493HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID435 reports
- V-Loc 180 VLOCL0316Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall376 reports
- Coated VICRYL VCP345HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death405 reports
- V-Loc 180 VLOCL0604Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall328 reports
- V-Loc 180 VLOCA008LCovidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall294 reports
- V-Loc 180 VLOCL0326Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID330 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.