MONOCRYL MCP936HRecalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 10705031046757), received between Feb 22, 2018 and Sep 23, 2026 — classified as 23 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Break” (21 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 10, 2024Open, Classified

   Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

   Z-2149-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873905 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AT THE TIME OF SUTURING IN CESAREAN SECTION SURGERY, THE SURGEON INDICATES THAT SUTURE THREAD BREAKS WITHOUT HAVING GENERATED FORCE OR ANY PULL OF THE THREAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839399 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WITH THE SAME LOT NUMBER WAS BROKEN FOUR TIMES DURING USE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512074 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WITH THE SAME LOT NUMBER WAS BROKEN FOUR TIMES DURING USE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511596 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WITH THE SAME LOT NUMBER WAS BROKEN FOUR TIMES DURING USE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505591 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WITH THE SAME LOT NUMBER WAS BROKEN FOUR TIMES DURING USE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505590 ↗
• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHILE BEING USED, NEEDLE ON MONOCRYL PLUS SUTURE BROKE. THERE WERE NO SURGICAL DELAYS REPORTED. FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494791 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, END OF NEEDLE (ABOUT 2MM PORTION) BROKE OFF DURING USE AND WAS UNABLE TO BE FOUND. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251436 ↗
• MalfunctionJul 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEMORRHOIDECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. IN THE MIDDLE OF THE PROCEDURE, THE NEEDLE POPPED OFF. THE NEEDLE SEPARATED WHILE PASSING THROUGH THE TISSUE. XRAY WAS NEEDED TO FIND THE NEEDLE. THE NEEDLE WAS RETRIEVED. IT ADDED 20 MINS. TO THE PROCEDURE AND EXTRA 20CC OF BLOOD LOSS. THE PATIENT IS DOING FINE AFTER THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 22522928 ↗
• MalfunctionMay 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE IS EASILY RELEASED FROM THE WIRE, MAKING IT IMPOSSIBLE TO PERFORM SUTURE IN SKIN (INTRADERMICA CONTINUES), AN ATTEMPT TO USE 4 UNITS, ALL WITH THE SAME PROBLEM. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959650 ↗
• MalfunctionMay 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE IS EASILY RELEASED FROM THE WIRE, MAKING IT IMPOSSIBLE TO PERFORM SUTURE IN SKIN (INTRADERMICA CONTINUES), AN ATTEMPT TO USE 4 UNITS, ALL WITH THE SAME PROBLEM. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959618 ↗
• MalfunctionMay 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE IS EASILY RELEASED FROM THE WIRE, MAKING IT IMPOSSIBLE TO PERFORM SUTURE IN SKIN (INTRADERMICA CONTINUES), AN ATTEMPT TO USE 4 UNITS, ALL WITH THE SAME PROBLEM. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959615 ↗
• MalfunctionMay 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE IS EASILY RELEASED FROM THE WIRE, MAKING IT IMPOSSIBLE TO PERFORM SUTURE IN SKIN (INTRADERMICA CONTINUES), AN ATTEMPT TO USE 4 UNITS, ALL WITH THE SAME PROBLEM. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959611 ↗
• MalfunctionFeb 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE ABOUT ONE INCH PAST THE SWEDGE. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332109 ↗
• MalfunctionFeb 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE ABOUT ONE INCH PAST THE SWEDGE. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332108 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. IN THE LAST 6-8WKS THE PATIENT EXPERIENCED A WOUND DEHISCENCE ALONG THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21060176 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. IN THE LAST 6-8WKS THE PATIENT EXPERIENCED A WOUND DEHISCENCE ALONG THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21060175 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. IN THE LAST 6-8WKS THE PATIENT EXPERIENCED A WOUND DEHISCENCE ALONG THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21060174 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. IN THE LAST 6-8WKS THE PATIENT EXPERIENCED A WOUND DEHISCENCE ALONG THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21060172 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. IN THE LAST 6-8WKS THE PATIENT EXPERIENCED A WOUND DEHISCENCE ALONG THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21060171 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. IN THE LAST 6-8WKS THE PATIENT EXPERIENCED A WOUND DEHISCENCE ALONG THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21060169 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT OVER THE PAST WEEK DURING CARDIOVASCULAR PROCEDURES THAT THEY HAVE BEEN HAVING ISSUES WITH THE SUTURE BREAKING ABOUT ONE INCH PAST THE SWEDGE. ANOTHER LIKE DEVICE WOULD BE USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO PRODUCT RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028769 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT OVER THE PAST WEEK DURING CARDIOVASCULAR PROCEDURES THAT THEY HAVE BEEN HAVING ISSUES WITH THE SUTURE BREAKING ABOUT ONE INCH PAST THE SWEDGE. ANOTHER LIKE DEVICE WOULD BE USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO PRODUCT RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028763 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING FOLLOW UP VISIT, DOCTOR FOUND INFECTION ON THE SUTURED SITE. DOCTOR WAS IN DOUBT WHETHER IT IS FROM SUTURE OR NOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 19949701 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING FOLLOW UP VISIT, DOCTOR FOUND INFECTION ON THE SUTURED SITE. DOCTOR WAS IN DOUBT WHETHER IT IS FROM SUTURE OR NOT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 19949697 ↗