Biosyn CM-925Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10884521032187), received between Oct 26, 2018 and Sep 5, 2023 — classified as 3 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 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 32 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN DISASSEMBLING, THE NEEDLE FLEW OUT AND WAS NOT FOUND. THE PATIENT HAD AN OPEN CAVITY AND FOR THIS REASON, A PLATE WAS GOING TO BE PERFORMED. ALSO, IN SOME PROCEDURES, THERE WAS MORE BLEEDING THAN NORMAL.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17686329 ↗
• MalfunctionAug 11, 2023Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE THREAD BROKEN. THERE WAS ALSO MORE BLEEDING THAN NORMAL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 17515853 ↗
• MalfunctionAug 11, 2023Break; Break

  ACCORDING TO THE REPORTER, THE TWO WAS THREAD BROKEN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17515838 ↗
• MalfunctionAug 11, 2023Break; Break

  ACCORDING TO THE REPORTER, THE TWO DEVICES HAD THEIR THREAD BROKEN. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17515803 ↗
• MalfunctionAug 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD WHILE THE SURGEON WAS DOING A CONTINUOUS SUTURING TECHNIQUE.

  Patient problems: Insufficient Information

  MAUDE report 12300948 ↗
• MalfunctionJul 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE TIME OF PASSING THE NEEDLE TO THE TISSUE TO CLOSE A CAESAREAN PROCEDURE, THE DEVICE DISASSEMBLED LEAVING THE NEEDLE AND THREAD SEPARATED. THE MALFUNCTION OCCURRED ON THREE DEVICES. ANOTHER COMPANY¿S DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12183717 ↗
• MalfunctionJul 14, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, THE NEEDLE BROKE ON THREE DEVICES. TO RESOLVE THE ISSUE, THE SURGEON USE A DIFFERENT SUTURE FROM ANOTHER PROVIDER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12169369 ↗
• MalfunctionJul 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE OFF THE NEEDLE AND THEY HAD TO CHANGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10263669 ↗
• MalfunctionJul 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A CAESAREAN SECTION, DURING UTERINE CLOSURE, THERE WERE 5 SUTURES FROM THE SAME LOT WHERE THE NEEDLE CAME OFF THE THREAD EASILY AS THEY WERE TAKEN OUT OF THE PACKAGE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10228199 ↗
• MalfunctionJul 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION PROCEDURE, ON UTERINE CLOSURE, THE NEEDLE EASILY CAME OFF THE THREAD WHEN TRYING TO MAKE A KNOT. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224795 ↗
• MalfunctionJun 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON AN OPEN ABDOMINAL HYSTERECTOMY, DURING THE BEGINNING OF THE PROCEDURE, WHILE EMPLOYING THE CONTINUOUS SUTURING TECHNIQUE, THE NEEDLE AND THREAD OF THREE SUTURES FROM THE SAME LOT DETACHED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10137870 ↗
• MalfunctionMay 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESARIAN SECTION, WHEN THE DEVICE WAS PULLED FROM THE PACKAGE, THE NEEDLE POPPED OFF EVEN WHEN THE DEVICE WAS ON THE SWEDGE. ANOTHER DEVICE HAD THE SAME ISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10084323 ↗
• MalfunctionApr 6, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LAPAROTOMY PROCEDURE, THE DEVICE THREAD BROKE. 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 9931538 ↗
• MalfunctionApr 2, 2020Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE THREAD BROKE. 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 9916977 ↗
• MalfunctionApr 2, 2020Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916807 ↗
• MalfunctionApr 1, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD OF THE DEVICE BROKE. SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913655 ↗
• MalfunctionMar 25, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE USING A RUNNING STITCH TECHNIQUE, THE NEEDLE BROKE OFF THE SUTURE THREAD WITH LIMITED AND NORMAL AMOUNT OF TENSION. IT HAPPENED FOUR TIMES THAT DAY WITH THE SAME PATIENT. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9880313 ↗
• MalfunctionFeb 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VETERINARY CASE, THE SWAGED NEEDLE DETACHED FROM THE SUTURE DURING INCISION CLOSURE. 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 9681899 ↗
• MalfunctionFeb 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VETERINARY CASE, THE DEVICE NEEDLE DETACHED FROM TWO SEPARATE PACKAGES OF SUTURE AS IT WAS BEING WITHDRAWN FROM THE PACKAGING. 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 9681898 ↗
• MalfunctionJan 29, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SUTURE BROKE, IT SNAPPED OFF OF THE NEEDLE. ANOTHER SUTURE WITH THE SAME LOT NUMBER WAS OPENED BUT THE SAME THING HAPPENED. A DIFFERENT BOX OF SUTURES WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641506 ↗
• MalfunctionJan 2, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A CEASAREAN SECTION PROCEDURE, DURING THE CLOSURE OF THE UTERUS, THE SUTURE'S NEEDLE WAS BROKEN. TWO NEEDLES WERE BROKEN ON THE SECOND AND THIRD SUTURE DURING THE CLOSURE OF THE SKIN. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9537862 ↗
• MalfunctionJan 2, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING CLOSURE OF THE UTERUS ON A CAESAREAN SECTION, THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9537838 ↗
• MalfunctionJan 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CAESAREAN SECTION, THE NEEDLE CAME OFF SUTURE WHEN PULLING OUT OF PACKAGE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9537813 ↗
• InjurySep 24, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING THE CLOSURE OF THE UTERUS IN A CAESARIAN SECTION OPEN PROCEDURE, THE THREADS BROKE. DEHISCENCE OCCURRED IN THE UTERUS, BUT THE COMPLICATION WAS RESOLVED USING ANOTHER DEVICE. COMPLICATION CAUSES EXTENDED SURGICAL TIME.

  Patient problems: No Code Available; Organ Dehiscence

  MAUDE report 9112809 ↗
• InjurySep 24, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING THE CLOSURE OF THE UTERUS IN A CAESARIAN SECTION OPEN PROCEDURE, THE THREADS BROKE. DEHISCENCE OCCURRED IN THE UTERUS, BUT THE COMPLICATION WAS RESOLVED USING ANOTHER DEVICE. COMPLICATION CAUSES EXTENDED SURGICAL TIME.

  Patient problems: No Code Available; Organ Dehiscence

  MAUDE report 9112799 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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

…and 13 more.