Biosyn UM-204Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10884521033368), received between Mar 6, 2018 and Aug 13, 2024 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 10 DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction

  MAUDE report 19977756 ↗
• MalfunctionAug 13, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 10 DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction

  MAUDE report 19977598 ↗
• MalfunctionAug 13, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 10 DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction

  MAUDE report 19977540 ↗
• MalfunctionAug 13, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 10 DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction

  MAUDE report 19977465 ↗
• MalfunctionAug 13, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 10 DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction

  MAUDE report 19977425 ↗
• MalfunctionAug 13, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 10 DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction

  MAUDE report 19977244 ↗
• MalfunctionAug 13, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 10 DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction

  MAUDE report 19974248 ↗
• MalfunctionAug 13, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 10 DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction

  MAUDE report 19974109 ↗
• MalfunctionAug 13, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 10 DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction

  MAUDE report 19973630 ↗
• MalfunctionAug 12, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 10 DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction

  MAUDE report 19960175 ↗
• MalfunctionDec 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE NEEDLE AND THREAD DISENGAGED IMMEDIATELY WHEN TRYING TO USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9403733 ↗
• MalfunctionNov 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN TRYING TO USE THE NEEDLE AND THE THREAD, THEY IMMEDIATELY DISENGAGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9293135 ↗
• MalfunctionOct 21, 2019Break; Break

  ACCORDING TO THE REPORTER DURING A VETERINARY PROCEDURE, THE NEEDLE AND THREAD OF THE DEVICE BROKE RIGHT AFTER THEY ATTEMPT TO USE THE DEVICE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9216721 ↗
• MalfunctionSep 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE NEEDLE AND THE THREAD OF THE DEVICE WAS DISENGAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9137861 ↗
• MalfunctionMay 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE THREAD WAS FOUND TO BE DISENGAGED FROM THE NEEDLE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8650568 ↗
• MalfunctionFeb 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING USE IN PATIENT, NEEDLE DISENGAGEMENT OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT WAS REPORTED AS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331511 ↗
• MalfunctionFeb 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY IN A VETERINARY PROCEDURE, NEEDLE DISENGAGEMENT OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331510 ↗
• MalfunctionFeb 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY IN A VETERINARY PROCEDURE, NEEDLE DISENGAGEMENT OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331509 ↗
• MalfunctionFeb 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ON THE FIRST PACKET, NEEDLE DISENGAGEMENT OCCURRED SPORADICALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331506 ↗
• MalfunctionFeb 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE DISENGAGEMENT OCCURRED SPORADICALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8330899 ↗
• MalfunctionNov 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE IN USE, THE NEEDLE DISENGAGED BUT NOTHING FELL INTO THE PATIENT'S CAVITY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8113962 ↗
• MalfunctionMar 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: DURING A VETERINARY PROCEDURE, THE THREAD DETACHED FROM THE NEEDLE. AN ADDITIONAL SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO INJURY OR HARM TO THE ANIMAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7316189 ↗

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-1283-2020 · Dec 18, 2019 · Terminated
  Polysorb 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-1300-2020 · Dec 18, 2019 · Terminated
  Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
• Z-1274-2020 · Dec 18, 2019 · Terminated
  Polysorb 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 · 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-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-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-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-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-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-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-1288-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, b
• Z-1293-2020 · Dec 18, 2019 · Terminated
  Polysorb 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-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-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-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.