Biosyn GM-875Recalls & reported problems
Covidien LP · Monofilament Absorbable Suture · Class 2 · Implant
Quick summary
This Biosyn GM-875 is an absorbable synthetic suture made by Covidien, used to close wounds and surgical incisions. The 47 reports mostly describe the suture needle snapping — during surgery, while handling it, or even when the package was first opened — and the suture coming loose from the needle; in most cases surgeons switched to another suture to finish the case. There are no deaths and 2 injuries. 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
- 49
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10884521032828), received between Jul 24, 2017 and Sep 19, 2026 — classified as 2 injuries, 47 malfunctions.
The most frequently reported specific device problem is “Break” (43 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
- Break43
- Detachment of Device or Device Component11
- Adverse Event Without Identified Device or Use Problem1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- Insufficient Information7
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- Unintended Radiation Exposure2
- No Code Available1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50831750 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50831584 ↗MalfunctionAug 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50221320 ↗MalfunctionJul 8, 2026Break
IT WAS REPORTED THAT DURING A PEDIATRIC SURGICAL SKIN CLOSURE, THE NEEDLES OF THE TWO SUTURES BROKE. TO COMPLETE THE CASE, A SUTURE FROM ANOTHER BRAND WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25745262 ↗MalfunctionJun 5, 2026Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC PEDIATRIC SURGERY, TWO NEEDLES BROKE IMMEDIATELY UPON THE PACKAGE WAS OPENED AND BEFORE S UTURING BEGAN. ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE AND WAS OF THE SAME PRODUCT IDENTIFICATION AND LOT AS THE DEVICE WITH THE BROKEN NEEDLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414449 ↗MalfunctionJun 5, 2026Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC PEDIATRIC SURGERY, TWO NEEDLES BROKE IMMEDIATELY UPON THE PACKAGE WAS OPENED AND BEFORE SUTURING BEGAN. ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE AND WAS OF THE SAME PRODUCT IDENTIFICATION AND LOT AS THE DEVICE WITH THE BROKEN NEEDLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414384 ↗MalfunctionMay 19, 2026Break
IT WAS REPORTED THAT INTRAOPERATIVELY, THE NEEDLES BROKE SEVERAL TIMES DURING HANDLING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25213557 ↗MalfunctionMay 19, 2026Break
IT WAS REPORTED THAT INTRAOPERATIVELY, THE NEEDLES BROKE SEVERAL TIMES DURING HANDLING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25213461 ↗MalfunctionApr 6, 2026Break
ACCORDING TO THE REPORTER, DURING A FACIAL WOUND CLOSURE, AT THE TIME OF SUTURING THE SUBCUTANEOUS TISSUE AND INTRADERMAL OF THE SKIN, THE NEEDLE BROKE. IT OCCURRED ON TWO SUTURES. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793987 ↗MalfunctionApr 6, 2026Break
ACCORDING TO THE REPORTER, DURING A FACIAL WOUND CLOSURE, AT THE TIME OF SUTURING THE SUBCUTANEOUS TISSUE AND INTRADERMAL OF THE SKIN, THE NEEDLE BROKE. IT OCCURRED ON TWO SUTURES. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793955 ↗MalfunctionJan 28, 2026Break
ACCORDING TO THE REPORTER, DURING A SUPERFICIAL TUMOR EXCISION, THE SYNTHETIC ABSORBABLE SURGICAL SUTURE WAS NEEDED TO CLOSE THE WOUND, AFTER THE FIRST STITCH, THE SUTURE BROKE AND COULD NOT BE USED TO CONTINUE CLOSURE. THE SUTURE WAS IMMEDIATELY REPLACED, AND THE WOUND WAS CLOSED TO COMPLETE THE PROCEDURE. NO HARM WAS CAUSED TO THE PATIENT, AND THE RELATED DEVICE ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24206400 ↗MalfunctionJan 28, 2026Break
IT WAS REPORTED THAT DURING A SUPERFICIAL TUMOR EXCISION, WHILE BEING USED TO CLOSE THE WOUND AND UPON PLACING THE FIRST STITCH, THE SUTURE BROKE AND COULD NOT BE USED TO CONTINUE CLOSURE. THE SUTURE WAS IMMEDIATELY REPLACED, AND THE WOUND WAS CLOSED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24206378 ↗MalfunctionJan 28, 2026Break; No Apparent Adverse Event
IT WAS REPORTED THAT DURING USE, THE SUTURE BROKE. THE SUTURE WAS IMMEDIATELY REPLACED.
Patient problems: Insufficient Information
MAUDE report 24206256 ↗MalfunctionJan 27, 2026Break
IT WAS REPORTED THAT DURING A PEDIATRIC LAPAROSCOPIC PROCEDURE, WHILE CLOSING THE UMBILICAL INCISION, THE NEEDLE BROKE INTO TWO HALVES. THE NEEDLE WAS REASSEMBLED AND FOUND TO BE INTACT. A CONTINUOUS SUTURE TECHNIQUE WAS USED, AND THE SUTURE WAS OPENED AND USED IMMEDIATELY WITHOUT PRIOR TREATMENT OR HYDRATION. THE ISSUE WAS RESOLVED BY USING A NEW SUTURE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189613 ↗MalfunctionNov 13, 2025Break; Break
ACCORDING TO THE REPORTER WHEN THE SURGEON PERFORMED A SKIN MASS EXCISION, DURING ROUTINE SUTURING WITH A SUTURE, THE SUTURE NEEDLE BROKE. ALL FRAGMENTS OF THE BROKEN NEEDLE WERE INTACT AND THERE WERE NO REMNANTS LEFT IN THE WOUND. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23541991 ↗MalfunctionOct 21, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE SUBCUTANEOUS TISSUE, THE NEEDLE AND THREAD DETACHED. AFTER THAT, THE NEEDLE TIP SUDDENLY BROKE AS WELL. NO COMPONENT FALL INTO THE PATIENT'S CAVITY. THE BROKEN NEEDLE TIP WAS IMMEDIATELY LOCATED AND REASSEMBLED COMPLETELY, WITH NO FRAGMENTS LEFT INSIDE THE PATIENT. A NEW PRODUCT WAS THEN USED TO CONTINUE THE SURGICAL SUTURING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23354356 ↗InjurySep 5, 2025Break; Break
ACCORDING TO THE REPORTER DURING A SKIN SUTURING PROCEDURE, THE DOCTOR SUDDENLY DISCOVERED THAT THE SUTURE NEEDLE HAD BROKEN. IMMEDIATE EFFORTS WERE MADE TO LOCATE THE NEEDLE NEAR THE WOUND, BUT WERE UNSUCCESSFUL. AN X-RAY WAS THEN USED TO SEARCH FOR THE BROKEN NEEDLE, WHICH WAS FOUND LODGED IN THE SKIN. FURTHER ATTEMPTS TO RETRIEVE IT WERE MADE, BUT THE NEEDLE COULD NOT BE LOCATED UNTIL AN ULTRASOUND MACHINE WAS USED TO ASSIST IN FINDING THE BROKEN NEEDLE. THE NEEDLE WAS THEN PIECED TOGETHER WITH THE BROKEN END FOR COMPARISON, AND ITS COMPLETENESS WAS CONFIRMED JOINTLY WITH THE SURGEON.
Patient problems: Unintended Radiation Exposure
MAUDE report 22975725 ↗MalfunctionApr 30, 2025Break; Break
ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC BILATERAL INTERNAL RING SUTURE SURGERY, THE NEEDLE BROKE DURING THE SECOND STITCH. THE SURGEON IMMEDIATELY STOPPED THE PROCEDURE, LOCATED THE BROKEN FRAGMENT, AND SUCCESSFULLY REMOVED IT FROM THE PATIENT¿S SKIN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21933534 ↗InjuryFeb 26, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR, AFTER THE INSTRUMENTS AND ITEMS WERE COUNTED CORRECTLY BEFORE CLOSING THE BODY CAVITY, THE SURGEON DISINFECTED THE UMBILICUS. THE SCRUB NURSE ON THE OPERATING TABLE HANDED THE SURGEON A PAIR OF FINE FORCEPS AND A 0/5GM875 ABSORBABLE SUTURE NEEDLE, WHICH WAS CLAMPED WITH A 14CM THICK NEEDLE HOLDER. WHEN THE SURGEON WAS SUTURING THE FIRST STITCH, THE NEEDLE BROKE FROM THE BACK 1/3 JUST HALFWAY THROUGH THE STITCH. SO THE DOCTOR ON THE OPERATING TABLE, THE ASSISTANT AND THE SCRUB NURSE BEGAN TO SEARCH FROM THE NEEDLE INSERTION POINT. THE CIRCULATING NURSE PULLED AN X-RAY MACHINE TO ASSIST IN THE SEARCH. AFTER FIVE TO TEN MINUTES, IT WAS FINALLY FOUND AND REMOVED IN THE UMBILICAL MUSCLE LAYER. THEN IT WAS COMPARED WITH THE NEW INTACT SUTURE NEEDLE AND NO MISSING WAS FOUND. ANOTHER FILM WAS TAKEN TO CONFIRM THAT THERE WAS NO RESIDUE IN THE CHILD'S BODY. SO THE FOLLOWING SURGICAL PROCEDURES CONTINUED.
Patient problems: Unintended Radiation Exposure
MAUDE report 21473169 ↗MalfunctionJan 23, 2025Break; Break
ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC HEPATOBILIARY PROCEDURE, 36 SUTURE THREADS WERE BROKEN AT THE BEGINNING OF THE OPERATION. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21217774 ↗MalfunctionJan 17, 2025Break; Break
ACCORDING TO THE REPORTER, THE SUTURE WAS BROKEN.
Patient problems: Insufficient Information
MAUDE report 21183665 ↗MalfunctionNov 12, 2024Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN HAND INJURY SUTURING, WHEN APPLIED ON THE ARM WHILE USING CONTINUOUS SUTURING TECHNIQUE, THE THREADS OF THE TWO SUTURES WERE BROKEN. THE SUTURE WAS REPLACED WITH ANOTHER ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20667699 ↗MalfunctionSep 18, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A WISDOM TEETH SURGERY, SEVERAL NEEDLES BROKE IN TWO WHILE INSIDE THE PATIENT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20248683 ↗MalfunctionSep 18, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A WISDOM TEETH SURGERY, SEVERAL NEEDLES BROKE IN TWO WHILE INSIDE THE PATIENT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20248462 ↗MalfunctionAug 22, 2024Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN INDIRECT HERNIA, WHILE SKIN SUTURING, THE NEEDLE BROKE. A NEW SUTURE FROM THE SAME BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20024745 ↗
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-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-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-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-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-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-1283-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
- 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-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-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-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-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-1298-2020 · Dec 18, 2019 · TerminatedPolysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not i
- 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-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-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
…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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.