Biosyn CM-790LRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521104143), received between Oct 12, 2017 and Mar 16, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING, THE CONNECTION OF NEEDLE AND THREAD BROKE. THE ISSUE HAPPENED TO THREE SUTURES. A NEW SUTURE FROM ANOTHER OPERATING ROOM WAS OBTAINED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607015 ↗
• MalfunctionMar 16, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING, THE CONNECTION OF NEEDLE AND THREAD BROKE. THE ISSUE HAPPENED TO THREE SUTURES. A NEW SUTURE FROM ANOTHER OPERATING ROOM WAS OBTAINED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606963 ↗
• MalfunctionMar 16, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING, THE CONNECTION OF NEEDLE AND THREAD BROKE. THE ISSUE HAPPENED TO THREE SUTURES. A NEW SUTURE FROM ANOTHER OPERATING ROOM WAS OBTAINED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606843 ↗
• MalfunctionMar 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL COLECTOMY, THE NEEDLE AND SWAGE GOT BROKEN. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13635180 ↗
• MalfunctionFeb 8, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE PRODUCT SHOULD CONTAIN 12 PACKETS, BUT THERE WERE ONLY 11 PACKETS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480236 ↗
• MalfunctionNov 6, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING RENAL SURGERY, WHILE CLOSING THE SKIN, THE THREAD OF TWO DEVICES BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10805841 ↗
• MalfunctionAug 31, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING RENAL SURGERY, WHILE CLOSING THE SKIN, THE THREAD OF 2 DEVICE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10474287 ↗
• MalfunctionAug 31, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING RENAL SURGERY, WHILE CLOSING THE SKIN, THE THREAD OF 2 DEVICE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10474260 ↗
• MalfunctionDec 19, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TOTAL GASTRECTOMY, USING BOTH DEVICE IN ABDOMINAL CLOSURE IN THE OPERATION, AT THE THIRD STITCH, THE THREAD WAS SET TO THE TISSUE AND THE NEEDLE BROKE WHEN THE NEEDLE HOLDER WAS PULLED UP FOR PULLING UP THE THREAD. THE NEEDLE SWEDGE WAS NOT HELD. THERE WAS NO BROKEN PIECE WHEN THE NEEDLE BROKE AND IT SIMPLY BROKE IN TWO. THE NEEDLE WAS HELD BY THE NEEDLE HOLDER AND THE THREAD FELL TO THE ABDOMINAL CLOSURE SIDE FROM THE NEEDLE SWEDGE AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9496975 ↗
• MalfunctionSep 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE NEEDLE DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7859899 ↗
• MalfunctionAug 31, 2018Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, OUT OF THE PACKAGE, BOTH THE NEEDLE AND THREAD BROKE OF THE SUTURES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7837917 ↗
• MalfunctionOct 12, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A PROXIMAL PANCREATICODUODENECTOMY, THE LOOP OF THE DEVICE 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 6944710 ↗

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-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-1285-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - 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-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-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-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-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-1300-2020 · Dec 18, 2019 · Terminated
  Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
• 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-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-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-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-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-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

…and 13 more.