Biosyn GM-122Recalls & reported problems
Covidien LP · Monofilament Absorbable Suture,V-20,1x Violet Strand · Class 2 · Implant
Quick summary
This Covidien Biosyn absorbable suture is a violet thread used to close wounds that dissolves in the body. Many of the 113 reports describe the needle detaching from the thread, often while the suture is pulled from its retainer before surgery, and others describe the thread breaking. The reports include 4 injuries and no deaths. Reports rose to 25 in the last 12 months from 11 in the previous 12 months. No recalls name this device.
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
- 113
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 10884521032422), received between Dec 15, 2017 and Sep 21, 2026 — classified as 4 injuries, 109 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (63 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 Component63
- Break38
- Adverse Event Without Identified Device or Use Problem7
- Unraveled Material6
- Patient-Device Incompatibility4
- Material Twisted/Bent2
- Mechanics Altered2
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions73
- No Consequences Or Impact To Patient9
- No Known Impact Or Consequence To Patient8
- No Patient Involvement5
- Tissue Damage5
- Insufficient Information4
- Wound Dehiscence4
- Foreign Body In Patient3
Recent adverse event reports
The 25 most recent of 113 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Detachment of Device or Device Component
According to the reporter, during a procedure, while removing the suture from the retainer, the needle detached. A new suture was used to resolve the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50836918 ↗MalfunctionAug 19, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50322114 ↗MalfunctionAug 19, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50322111 ↗MalfunctionApr 15, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE REMOVING THE SUTURE FROM THE RETAINER, THE NEEDLE 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 24884636 ↗MalfunctionApr 3, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT INTRAOPERATIVELY, THE NEEDLE WAS DETACHED FROM THE SUTURE WHILE BEING REMOVED FROM THE RETAINER PRIOR TO PATIENT INCISION. 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 24784288 ↗MalfunctionFeb 25, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PREOPERATIVELY, BEFORE PATIENT USE, WHEN BEING PULLED OUT FROM THE RETAINER, THE NEEDLE WAS DETACHED. ANOTHER NEW SUTURE WAS USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24449421 ↗MalfunctionFeb 24, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE THREAD OF TWO SUTURES DETACHED FROM THE NEEDLE WHILE BEING WITHDRAWN FROM THEIR RETAINERS. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24428579 ↗MalfunctionFeb 24, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE THREAD OF TWO SUTURES DETACHED FROM THE NEEDLE WHILE BEING WITHDRAWN FROM THEIR RETAINERS. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24428532 ↗MalfunctionFeb 3, 2026Detachment of Device or Device Component
ACCORDING TO THE VETERINARY REPORT, A NEEDLE OF A SUTURE CAME OFF DURING SURGERY. NO COMPONENT FELL INTO THE CAVITY OF THE PATIENT. ANOTHER SUTURE 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 24255038 ↗MalfunctionFeb 3, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, TWO SUTURES BROKE WHILE SUTURING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251046 ↗MalfunctionFeb 3, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, TWO SUTURES BROKE WHILE SUTURING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24250751 ↗MalfunctionJan 29, 2026Detachment of Device or Device Component
ACCORDING TO A VETERINARY CASE, DURING SUTURING, TWO NEEDLES BROKE OFF THE SUTURE TOWARDS THE END. ANOTHER SUTURE 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 24206752 ↗MalfunctionJan 29, 2026Detachment of Device or Device Component
ACCORDING TO A VETERINARY CASE, DURING SUTURING, TWO NEEDLES BROKE OFF THE SUTURE TOWARDS THE END. ANOTHER SUTURE 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 24206747 ↗MalfunctionJan 23, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, ON TWO DEVICES, THE NEEDLE DETACHED AS A WHOLE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24164619 ↗MalfunctionJan 9, 2026Detachment of Device or Device Component
ACCORDING TO A VETERINARY REPORT , TWO NEEDLES CAME OFF. TO RESOLVE THE ISSUE, ANOTHER SUTURE OF THE SAME TYPE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24029821 ↗MalfunctionJan 9, 2026Detachment of Device or Device Component
ACCORDING TO A VETERINARY REPORT, TWO NEEDLES CAME OFF. TO RESOLVE THE ISSUE, ANOTHER SUTURE OF THE SAME TYPE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24029810 ↗MalfunctionJan 9, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, THE NEEDLE CAME OFF FROM THE SWAGE. TO RESOLVE THE ISSUE, A NEW SUTURE OF THE SAME TYPE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24019736 ↗MalfunctionJan 5, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, THE NEEDLE CAME OFF FROM THE SWAGE. THIS ISSUE OCCURRED ON TWO DEVICES. TO RESOLVE THE ISSUE, A NEW SUTURE OF THE SAME TYPE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23969362 ↗MalfunctionJan 5, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, THE NEEDLE CAME OFF FROM THE SWAGE. THIS ISSUE OCCURRED ON TWO DEVICES. TO RESOLVE THE ISSUE, A NEW SUTURE OF THE SAME TYPE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23969257 ↗MalfunctionJan 5, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, THE NEEDLE CAME OFF FROM THE SWAGE. THIS ISSUE OCCURRED ON TWO DEVICES. TO RESOLVE THE ISSUE, A NEW SUTURE OF THE SAME TYPE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23961576 ↗MalfunctionJan 5, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, THE NEEDLE CAME OFF FROM THE SWAGE. THIS ISSUE OCCURRED ON TWO DEVICES. TO RESOLVE THE ISSUE, A NEW SUTURE OF THE SAME TYPE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23961416 ↗MalfunctionNov 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LIVER LOBECTOMY ON A VETERINARY PROCEDURE, FOUR NEEDLES CAME OFF FROM SUTURE MID SURGERY WITHIN 30 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23539863 ↗MalfunctionNov 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LIVER LOBECTOMY ON A VETERINARY PROCEDURE, FOUR NEEDLES CAME OFF FROM SUTURE MID SURGERY WITHIN 30 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23539771 ↗MalfunctionNov 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, FOUR NEEDLES CAME OFF FROM SUTURE MID SURGERY WITHIN 30 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23539752 ↗MalfunctionNov 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE, FOUR NEEDLES CAME OFF FROM SUTURE MID SURGERY WITHIN 30 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23539742 ↗
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-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-1289-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
- Z-1293-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but no
- Z-1297-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
- 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-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-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-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
- 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-1300-2020 · Dec 18, 2019 · TerminatedBiosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
- Z-1284-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
- 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-1274-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery,
- Z-1296-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
- Z-1287-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
…and 13 more.
Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices
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- 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.