Biosyn XX-5229JRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521113756), received between Aug 25, 2017 and Jun 15, 2020 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (14 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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE THREAD BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10152867 ↗
• MalfunctionOct 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SIGMOIDECTOMY PROCEDURE, AFTER OPENING THE DEVICE, THEY FOUND TWO PRODUCTS WITH THE NEEDLE AND THE THREAD DISENGAGED AND ONE PRODUCT WITH BROKEN THREAD AT POINT OF LESS 1CM FROM THE NEEDLE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9227037 ↗
• MalfunctionOct 23, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A SIGMOIDECTOMY PROCEDURE, AFTER OPENING THE DEVICE, THEY FOUND TWO PRODUCTS WITH THE NEEDLE AND THE THREAD DISENGAGED AND ONE PRODUCT WITH BROKEN THREAD AT POINT OF LESS 1CM FROM THE NEEDLE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9227034 ↗
• MalfunctionJun 13, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING PEDIATRIC PROCEDURE, WHEN KNOTTING THE THREAD, THE THREAD BROKE, SO THE SUTURE COULD NOT BE USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8697435 ↗
• MalfunctionMay 10, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWO SUTURES BROKE WHILE MAKING A NODULE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8600766 ↗
• MalfunctionOct 16, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING, THE SUTURE THREAD BROKE. NOTHING FELL INTO THE CAVITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE DEVICE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6952073 ↗
• MalfunctionOct 16, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING, THE DEVICE THREAD BROKE. NOTHING FELL INTO THE PATIENT CAVITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE DEVICE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6952058 ↗
• MalfunctionOct 16, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING THE THREAD BROKE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6951799 ↗
• MalfunctionOct 16, 2017Break; Break

  ACCORDING TO THE REPORTER, THE THREAD BROKE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6951775 ↗
• MalfunctionOct 16, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING THE THREAD BROKE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6951497 ↗
• MalfunctionOct 10, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING, THE THREAD BROKE IN PIECE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6937518 ↗
• MalfunctionOct 10, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING, THE THREAD BROKE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6937462 ↗
• MalfunctionOct 9, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING, THE THREAD BROKE IN PIECE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6929264 ↗
• MalfunctionOct 6, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING, THE THREAD BROKE IN PIECE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6922770 ↗
• MalfunctionAug 25, 2017Break; Break

  ACCORDING TO THE REPORTER, A NURSE MERELY MENDED THE KINK WITH SLIGHT FORCE BUT THE THREAD BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6822944 ↗

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 · Terminated
  Polysorb 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-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-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-1280-2020 · Dec 18, 2019 · Terminated
  Polysorb 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 · 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-1296-2020 · Dec 18, 2019 · Terminated
  Polysorb 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-1300-2020 · Dec 18, 2019 · Terminated
  Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
• 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-1287-2020 · Dec 18, 2019 · Terminated
  Polysorb 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
• 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-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-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-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-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-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

…and 13 more.