Biosyn CM-879Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10884521032095), received between Oct 10, 2017 and May 16, 2025 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (19 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CANINE OVARIOHYSTERECTOMY, THE SUTURE DISCONNECTED FROM THE NEEDLE WHILE IN THE MIDDLE OF CLOSING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038982 ↗
• MalfunctionMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VETERINARY CANINE OVARIOHYSTERECTOMY, THE SUTURE DISCONNECTED FROM THE NEEDLE BASE WHILE IN THE MIDDLE OF CLOSING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22032284 ↗
• MalfunctionMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CANINE OVARIOHYSTERECTOMY, THE SUTURE DISCONNECTED FROM THE NEEDLE WHILE IN THE MIDDLE OF CLOSING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027670 ↗
• MalfunctionApr 18, 2025Break; Break

  IT WAS REPORTED THAT THE SUTURE BROKE EASILY WHEN TYING KNOTS.

  Patient problems: Insufficient Information

  MAUDE report 21866129 ↗
• MalfunctionApr 16, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POSTOPERATIVELY TO THE OVARIECTOMY, THE SUTURE LINE DID NOT HOLD, AND THE CAT RETURNED THE SAME DAY WITH AN OPEN ABDOMEN AND LATER DIED. THE ISSUE WAS IDENTIFIED THROUGH A CT SCAN. THE PRODUCT WAS REPLACED BY ANOTHER MANUFACTURER'S PRODUCT, AND THE CAT WAS RE-ADMITTED TO THE HOSPITAL.

  Patient problems: Wound Dehiscence

  MAUDE report 21852828 ↗
• MalfunctionApr 2, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT ON MARCH 5TH, A VETERINARY OVARIECTOMY WAS PERFORMED. HOWEVER, ON MARCH 7TH, THE SUTURE LINE DID NOT HOLD, RESU LTING IN AN OPEN ABDOMEN. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL AND UNDERWENT ADDITIONAL SURGERY USING COMPETITIVE SUTURE STRANDS. THE PATIENT WAS REPORTED TO BE FINE AFTER THE PROCEDURE.

  Patient problems: Tissue Breakdown

  MAUDE report 21758793 ↗
• MalfunctionMay 12, 2022Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, MULTIPLE THREADS KEPT BREAKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14370446 ↗
• MalfunctionAug 9, 2021Break; Break

  ACCORDING TO THE REPORTER, FOLLOWING A CAESAREAN SECTION PROCEDURE, THE SUTURE BROKE UNEXPECTEDLY AFTER THE PATIENT HAD LEFT THE VETERINARY CLINIC. THE PATIENT WENT BACK TO THE CLINIC AND STAYED FOR 14 DAYS POST-OPERATIVELY. THE ABDOMEN CONTENTS REPLACED; ABDOMEN FLUSHED & WALL RE-SUTURED CAUSING AN EXTENDED EXCISION TO THE PATIENT. DURING THE PROCEDURE, THE SURGICAL TIME WAS ALSO EXTENDED FOR 30 MINUTES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12298316 ↗
• MalfunctionMar 26, 2020Unraveled Material; Unraveled Material

  DUPLICATE OF (B)(4).

  Patient problems: No Code Available

  MAUDE report 9887148 ↗
• MalfunctionJul 10, 2019Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THREE DAYS POST-OPERATIVE FROM A BLEEDING SPLEEN RESECTION, THE THREAD BROKE. THE DOG WAS BROUGHT BACK TO THE CLINIC WITH 400 CC BLOOD LOSS FROM THE WOUND. THE ECHO SHOWED A DISCONTINUITY OF THE WOUND LAYERS. THE ABDOMEN WAS ¿DRY.¿ AN EXTRA OPERATION WAS STARTED. IN BETWEEN THE SUTURED LAYERS, IT WAS FOUND THAT THERE WERE DRIED BLOOD CLOTS WHICH MAY HAVE PUSHED THE MUSCLE LAYERS APART. THE RUNNING SUTURES WERE NOT HOLDING THE WOUND EDGES ANYMORE.

  Patient problems: No Code Available; No Information

  MAUDE report 8777890 ↗
• MalfunctionAug 15, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE AN EYE ENUCLEATION PROCEDURE, THERE WAS SUTURE REACTION AND STERILE ABSCESS WAS SEEN.

  Patient problems: Abscess

  MAUDE report 7786355 ↗
• MalfunctionAug 15, 2018Unraveled Material; Patient-Device Incompatibility; Unraveled Material; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THE PATIENT HAD POST MAST CELL CANCER REMOVAL SUTURE REACTION AND INCISION COMPLETELY OPENED RIGHT LATERAL THORAX SUPERFICIALLY. IT WAS ALSO NOTED THAT THERE WAS WOUND DEHISCENCE. THE PATIENT WAS RE-SUTURED TO COMPLETE THE CASE.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 7784687 ↗
• MalfunctionAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD POST SURGERY COMPLICATIONS WHICH INCLUDED EYE ENUCLEATION OS AND STERILE ABSCESS WHICH IS NOT PART OF THE DEVICE PROBLEM THE PATIENT TOOK A TOPICAL ANTI-BIOTIC. THERE WAS NO INJURY.

  Patient problems: Abscess; Eye Injury

  MAUDE report 7782493 ↗
• MalfunctionNov 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PRODUCT'S NEEDLE WAS RIPPING OFF AND MULTIPLE PRODUCT WAS BROKEN. NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7060774 ↗
• MalfunctionNov 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN VETERINARIAN PROCEDURE, THE DEVICE HAD MANY BREAKS AND THE NEEDLE WAS RIPPING OFF. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7060449 ↗
• MalfunctionNov 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN VETERINARIAN PROCEDURE, THE DEVICE HAD MANY BREAKS AND THE NEEDLE WAS RIPPING OFF. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7060443 ↗
• MalfunctionNov 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN VETERINARIAN PROCEDURE, THE DEVICE HAD MANY BREAKS AND THE NEEDLE WAS RIPPING OFF. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7060422 ↗
• MalfunctionNov 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN VETERINARIAN PROCEDURE, THE DEVICE HAD MANY BREAKS AND THE NEEDLE WAS RIPPING OFF. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7060414 ↗
• MalfunctionNov 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN VETERINARIAN PROCEDURE, THE DEVICE HAD MANY BREAKS AND THE NEEDLE WAS RIPPING OFF. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7059193 ↗
• MalfunctionNov 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PRODUCT'S NEEDLE WAS RIPPING OFF AND MULTIPLE PRODUCT WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7059076 ↗
• MalfunctionNov 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PRODUCT'S NEEDLE WAS RIPPING OFF AND MULTIPLE PRODUCT WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7059057 ↗
• MalfunctionNov 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PRODUCT'S NEEDLE WAS RIPPING OFF AND MULTIPLE PRODUCT WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7059026 ↗
• MalfunctionNov 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PRODUCT HAD MULTIPLE BREAKS AND ITS NEEDLE RIPPING OFF. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7059012 ↗
• MalfunctionNov 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PRODUCT'S NEEDLE WAS RIPPING OFF AND MULTIPLE PRODUCT WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7058986 ↗
• MalfunctionNov 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD MANY BREAKS AND THE NEEDLE WAS RIPPING OFF. PATIENT INVOLVEMENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7058974 ↗

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-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-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-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-1300-2020 · Dec 18, 2019 · Terminated
  Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
• 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-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-1299-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - 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-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-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-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-1282-2020 · Dec 18, 2019 · Terminated
  Polysorb 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-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-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-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

…and 13 more.