Biosyn SM-5637Recalls & reported problems

Summary

The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 10884521033078), received between Sep 15, 2017 and Apr 1, 2026 — classified as 31 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Break” (72 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 147 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE USING THE SUTURE, THE SUTURE BROKE WHILE SUTURING. THE SURGICAL TIME WAS EXTENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24761150 ↗
• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE USING THE SUTURE, THE SUTURE BROKE WHILE SUTURING. THE SURGICAL TIME WAS EXTENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24761147 ↗
• MalfunctionFeb 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, BREAKAGE OCCURRED AT THE JUNCTION WITH THE NEEDLE MORE THAN 15 TIMES. THE PRODUCTS WERE NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470164 ↗
• MalfunctionFeb 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, BREAKAGE OCCURRED AT THE JUNCTION WITH THE NEEDLE MORE THAN 15 TIMES. THE PRODUCTS WERE NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470082 ↗
• MalfunctionFeb 13, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE WAS DETACHED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330796 ↗
• MalfunctionFeb 13, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE DETACHED WHILE SUTURING. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330427 ↗
• MalfunctionJan 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO NEEDLES WERE DETACHED FROM THE SUTURE WHILE SUTURING OR PREPARING THE SUTURE AFTER THE PATIENT INCISION. THE PROCEDURE TIME WAS EXTENDED BY APPROXIMATELY 30 MINUTES DUE TO THE DEVICE ISSUE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY, AND AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24031989 ↗
• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SUTURE BROKE. ALL PIECES WERE RECOVERED.

  Patient problems: Insufficient Information

  MAUDE report 24024204 ↗
• MalfunctionJan 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO NEEDLES WERE DETACHED FROM THE SUTURE WHILE SUTURING OR PREPARING THE SUTURE AFTER THE PATIENT INCISION. THE PROCEDURE TIME WAS EXTENDED BY APPROXIMATELY 30 MINUTES DUE TO THE DEVICE ISSUE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY, AND AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952234 ↗
• MalfunctionJan 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO NEEDLES WERE DETACHED FROM THE SUTURE WHILE SUTURING OR PREPARING THE SUTURE AFTER THE PATIENT INCISION. THE PROCEDURE TIME WAS EXTENDED BY APPROXIMATELY 30 MINUTES DUE TO THE DEVICE ISSUE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY, AND AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952219 ↗
• MalfunctionDec 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE SUTURES BROKE WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892333 ↗
• MalfunctionDec 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE SUTURES BROKE WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892326 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT DURING THE CLOSING STEP OF A ROBOTIC LAPAROSCOPIC SLEEVE PROCEDURE, THE SUTURE BROKE WHILE SUTURING. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23591641 ↗
• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC BILATERAL SALPINGECTOMY, THE SUTURE BROKE IN THE MIDDLE WHILE CLOSING THE PORT SITES. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23103000 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT DURING A LEFT CAROTID ENDARTERECTOMY OPEN PROCEDURE; WHILE CLOSING THE SKIN, THE SUTURE BROKE IN THE MIDDLE DURING SUTURING AND THEN IT UNRAVELED, AS DETERMINED DURING THE PROCEDURE. THESE ISSUES RESULTED IN AN EXTENDED SURGICAL TIME OF AT LEAST FIVE MINUTES AND REQUIRED COMPLETE RE-SUTURING OF THE ENTIRE INCISION. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896071 ↗
• MalfunctionAug 21, 2025Break; Material Frayed; Break; Material Frayed

  ACCORDING TO THE REPORTER, DURING A ROBOTIC ASSISTED LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR, WHEN CLOSING THE TROCAR SITES, THE STRANDS KNOTS WOULD NOT HOLD WITH 5-6 KNOTS AND THE THREAD KEPT BREAKING. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22867775 ↗
• MalfunctionMay 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING BIOSYN* 4-0 SUTURES, THE NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING/PREPARING THE SUTURE AFTER THE PATIENT INCISION. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE FROM THE SAME BATCH AND THREE OTHER SUTURES FROM A DIFFERENT BATCH. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019746 ↗
• MalfunctionMay 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING BIOSYN 4-0 SUTURES, THE NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING/PREPARING THE SUTURE AFTER THE PATIENT INCISION. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE FROM THE SAME BATCH AND THREE OTHER SUTURES FROM A DIFFERENT BATCH. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019661 ↗
• MalfunctionMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING BIOSYN* 4-0 SUTURES, THE NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING/PREPARING THE SUTURE AFTER THE PATIENT INCISION. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE FROM THE SAME BATCH AND THREE OTHER SUTURES FROM A DIFFERENT BATCH. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011788 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT DURING THE USE OF THE SUTURE, THE SUTURE BROKE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21879860 ↗
• MalfunctionNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, AFTER A BREAST REDUCTION SURGERY, THE PATIENT ACQUIRED INFECTION POSTOPERATIVELY. WOUND TREATMENT WAS DONE. THE SUTURE WAS REMOVED AND DISCARDED.

  Patient problems: Unspecified Infection

  MAUDE report 20740385 ↗
• MalfunctionNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 53 DAYS POSTOPERATIVELY OF BREAST REDUCTION, THERE WAS AN INFECTION. A WOUND CARE SUCH AS TOPICAL ANTISEPTIC OINTMENT AND WOUND GEL WERE APPLIED TO TREAT THE INFECTION. IT WAS NOTED THAT THE SUTURE WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 20666454 ↗
• MalfunctionJun 19, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE THREAD BROKE AND THE NEEDLE FELL OFF THE THREAD WITHOUT ANY MAJOR EFFORT APPLIED. THE ISSUE HAPPENED ON TWO OCCASIONS WITH SUTURES FROM TWO DIFFERENT LOT NUMBERS.

  Patient problems: Insufficient Information

  MAUDE report 19568797 ↗
• MalfunctionApr 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PLASTIC SURGERY, WHEN THE SURGEON WAS CLOSING UP THE SKIN INCISION WHILE SUTURING, THE SUTURE CAME OFF AT THE SWAGE OF THE NEEDLE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101582 ↗
• MalfunctionApr 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE SUTURE WAS USED TO CLOSE THE SKIN, THE SUTURE BROKE OFF THE SWAGE.

  Patient problems: Insufficient Information

  MAUDE report 19094097 ↗

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-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-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-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-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-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
• 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-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-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-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-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-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-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

…and 13 more.