Biosyn GM-327Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521032736), received between Aug 20, 2024 and Jun 25, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (16 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. 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE WHILE SUTURING, THE SUTURE THREAD BROKE OR NEEDLE ALSO SNAPPED AT THE CRIMPING POINT (CONNECTION OF NEEDLE AND THREAD).

  Patient problems: Insufficient Information

  MAUDE report 25631234 ↗
• MalfunctionJun 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE WHILE SUTURING, THE SUTURE THREAD BROKE OR NEEDLE ALSO SNAPPED AT THE CRIMPING POINT (CONNECTION OF NEEDLE AND THREAD).

  Patient problems: Insufficient Information

  MAUDE report 25631227 ↗
• MalfunctionJun 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE WHILE SUTURING, THE SUTURE THREAD BROKE OR NEEDLE ALSO SNAPPED AT THE CRIMPING POINT (CONNECTION OF NEEDLE AND THREAD).

  Patient problems: Insufficient Information

  MAUDE report 25631209 ↗
• MalfunctionJun 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE WHILE SUTURING, THE SUTURE THREAD BROKE OR NEEDLE ALSO SNAPPED AT THE CRIMPING POINT (CONNECTION OF NEEDLE AND THREAD).

  Patient problems: Insufficient Information

  MAUDE report 25631177 ↗
• MalfunctionJun 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE WHILE SUTURING, THE SUTURE THREAD BROKE OR NEEDLE ALSO SNAPPED AT THE CRIMPING POINT (CONNECTION OF NEEDLE AND THREAD).

  Patient problems: Insufficient Information

  MAUDE report 25631111 ↗
• MalfunctionJun 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE WHILE SUTURING, THE SUTURE THREAD BROKE OR NEEDLE ALSO SNAPPED AT THE CRIMPING POINT (CONNECTION OF NEEDLE AND THREAD).

  Patient problems: Insufficient Information

  MAUDE report 25631071 ↗
• MalfunctionJun 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE WHILE SUTURING, THE SUTURE THREAD BROKE OR NEEDLE ALSO SNAPPED AT THE CRIMPING POINT (CONNECTION OF NEEDLE AND THREAD).

  Patient problems: Insufficient Information

  MAUDE report 25631056 ↗
• MalfunctionJun 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE SUTURE THREAD BROKE OR NEEDLE ALSO SNAPPED AT THE CRIMPING POINT (CONNECTION OF NEEDLE AND THREAD).

  Patient problems: Insufficient Information

  MAUDE report 25621870 ↗
• MalfunctionJun 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE SUTURE THREAD BROKE OR NEEDLE ALSO SNAPPED AT THE CRIMPING POINT (CONNECTION OF NEEDLE AND THREAD). IT WAS NOTED THAT THREE SUTURES WERE USED AND THREE STITCHES WERE ADDED TO THE FRAGILE WALL. TO RESOLVE THE ISSUE, IT REQUIRED OVERLOCKED STITCHING THREE TIMES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414967 ↗
• MalfunctionJun 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE SUTURE THREAD BROKE OR NEEDLE ALSO SNAPPED AT THE CRIMPING POINT (CONNECTION OF NEEDLE AND THREAD). IT WAS NOTED THAT THREE SUTURES WERE USED AND THREE STITCHES WERE ADDED TO THE FRAGILE WALL. TO RESOLVE THE ISSUE, IT REQUIRED OVERLOCKED STITCHING THREE TIMES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414729 ↗
• MalfunctionMar 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. IT WAS NOTED THAT THREE SUTURES WERE USED DURING THE SAME EVENT WITH THE SAME PATIENT. THE SURGICAL TIME WAS EXTENDED DUE TO THE PRODUCT ISSUE. 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 24523780 ↗
• MalfunctionMar 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. IT WAS NOTED THAT THREE SUTURES WERE USED DURING THE SAME EVENT WITH THE SAME PATIENT. THE SURGICAL TIME WAS EXTENDED DUE TO THE PRODUCT ISSUE. 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 24523753 ↗
• MalfunctionMar 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. IT WAS NOTED THAT THREE SUTURES WERE USED DURING THE SAME EVENT WITH THE SAME PATIENT. THE SURGICAL TIME WAS EXTENDED DUE TO THE PRODUCT ISSUE. 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 24523657 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE OF THE SUTURE, THE NEEDLE DETACHED FROM THE THREAD WHILE SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. ANOTHER BATCH WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24373376 ↗
• MalfunctionAug 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A COELIO TO EXPLORE HEMOSTASIS PROCEDURE, THE THREAD DETACHED FROM THE NEEDLE. THE SAME ISSUE OCCURRED WITH THE SECOND SUTURE. A THIRD SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20023432 ↗
• MalfunctionAug 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A COELIO TO EXPLORE HEMOSTASIS PROCEDURE, THE THREAD DETACHED FROM THE NEEDLE. THE SAME ISSUE OCCURRED WITH THE SECOND SUTURE. A THIRD SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006440 ↗

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-1281-2020 · Dec 18, 2019 · Terminated
  Polysorb 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-1276-2020 · Dec 18, 2019 · Terminated
  Polysorb 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-1286-2020 · Dec 18, 2019 · Terminated
  Polysorb 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-1289-2020 · Dec 18, 2019 · Terminated
  Polysorb 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-1295-2020 · Dec 18, 2019 · Terminated
  Polysorb 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-1290-2020 · Dec 18, 2019 · Terminated
  Polysorb 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-1294-2020 · Dec 18, 2019 · Terminated
  Polysorb 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-1279-2020 · Dec 18, 2019 · Terminated
  Polysorb 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 · Terminated
  Polysorb 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-1297-2020 · Dec 18, 2019 · Terminated
  Polysorb 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-1292-2020 · Dec 18, 2019 · Terminated
  Polysorb 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-1278-2020 · Dec 18, 2019 · Terminated
  Polysorb 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-1284-2020 · Dec 18, 2019 · Terminated
  Polysorb 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-1298-2020 · Dec 18, 2019 · Terminated
  Polysorb 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-1275-2020 · Dec 18, 2019 · Terminated
  Polysorb 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

…and 13 more.