MONOCRYL MCP945HRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031046795), received between Jun 27, 2018 and Jun 26, 2025 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT DURING C-SECTION, WHILE SUTURING, THE NEEDLE TIP BROKE OFF. NO PATIENT CONSEQUENCES. DEVICE IS RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336361 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE OR HIP SURGERY ON AN UNKNOWN DATE AND SUTURE WITH A PS1 OR CT1 NEEDLE WAS USED. THE PATIENT PRESENTED WITH SUTURE SPITTING BETWEEN WEEK 4 AND 8. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 22318639 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE OR HIP SURGERY ON AN UNKNOWN DATE AND SUTURE WITH A PS1 OR CT1 NEEDLE WAS USED. THE PATIENT PRESENTED WITH SUTURE SPITTING BETWEEN WEEK 4 AND 8. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 22318638 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE OR HIP SURGERY ON AN UNKNOWN DATE AND SUTURE WITH A PS1 OR CT1 NEEDLE WAS USED. THE PATIENT PRESENTED WITH SUTURE SPITTING BETWEEN WEEK 4 AND 8. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 22318637 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE OR HIP SURGERY ON AN UNKNOWN DATE AND SUTURE WITH A PS1 OR CT1 NEEDLE WAS USED. THE PATIENT PRESENTED WITH SUTURE SPITTING BETWEEN WEEK 4 AND 8. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 22318634 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE OR HIP SURGERY ON AN UNKNOWN DATE AND SUTURE WITH A PS1 OR CT1 NEEDLE WAS USED. THE PATIENT PRESENTED WITH SUTURE SPITTING BETWEEN WEEK 4 AND 8. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 22318633 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE OR HIP SURGERY ON AN UNKNOWN DATE AND SUTURE WITH A PS1 OR CT1 NEEDLE WAS USED. THE PATIENT PRESENTED WITH SUTURE SPITTING BETWEEN WEEK 4 AND 8. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 22318632 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281948 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281947 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281946 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281945 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281944 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281942 ↗
• InjuryJun 27, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROTOMY MYOMECTOMY PROCEDURE ON (B)(6) 2018 AND THE SUTURE WAS USED ON SEROSAL LAYERS OF THE UTERUS WHEN MULTIPLE UTERINE INCISIONS CLOSED IN STANDARD FASHION. DURING THE PROCEDURE, FIBROIDS WERE TAKEN OUT. THE PROCEDURE CONCLUDED WITHOUT COMPLICATIONS. IT WAS ALSO REPORTED THAT THE PATIENT SUBSEQUENTLY BECAME UNSTABLE, WENT INTO HYPOVOLEMIC SHOCK AND REQUIRED RETURN TO OPERATING ROOM ON (B)(6) 2018 FOR EXPLORATORY LAPAROTOMY. UPON INSPECTION OF THE ABDOMEN, THE SUTURE WAS MISSING ON THE UTERUS; NOT EVEN SCRAPS OF SUTURE WERE SEEN. UPON REENTRY, THERE WAS 1500 ML OF BLOOD IN THE ABDOMEN. IT WAS NOT NOTED HOW THE CASE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blood Loss; Hypovolemic Shock; Not Applicable

  MAUDE report 7642320 ↗
• InjuryJun 27, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROTOMY MYOMECTOMY PROCEDURE ON (B)(6) 2018 AND THE SUTURE WAS USED ON SEROSAL LAYERS OF THE UTERUS WHEN MULTIPLE UTERINE INCISIONS CLOSED IN STANDARD FASHION. DURING THE PROCEDURE, FIBROIDS WERE TAKEN OUT. THE PROCEDURE CONCLUDED WITHOUT COMPLICATIONS. IT WAS ALSO REPORTED THAT THE PATIENT SUBSEQUENTLY BECAME UNSTABLE, WENT INTO HYPOVOLEMIC SHOCK AND REQUIRED RETURN TO OPERATING ROOM ON (B)(6) 2018 FOR EXPLORATORY LAPAROTOMY. UPON INSPECTION OF THE ABDOMEN, THE SUTURE WAS MISSING ON THE UTERUS; NOT EVEN SCRAPS OF SUTURE WERE SEEN. UPON REENTRY, THERE WAS 1500 ML OF BLOOD IN THE ABDOMEN. IT WAS NOT NOTED HOW THE CASE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blood Loss; Hypovolemic Shock; Not Applicable

  MAUDE report 7642240 ↗
• InjuryJun 27, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROTOMY MYOMECTOMY PROCEDURE ON (B)(6) 2018 AND THE SUTURE WAS USED ON SEROSAL LAYERS OF THE UTERUS WHEN MULTIPLE UTERINE INCISIONS CLOSED IN STANDARD FASHION. DURING THE PROCEDURE, FIBROIDS WERE TAKEN OUT. THE PROCEDURE CONCLUDED WITHOUT COMPLICATIONS. IT WAS ALSO REPORTED THAT THE PATIENT SUBSEQUENTLY BECAME UNSTABLE, WENT INTO HYPOVOLEMIC SHOCK AND REQUIRED RETURN TO OPERATING ROOM ON (B)(6) 2018 FOR EXPLORATORY LAPAROTOMY. UPON INSPECTION OF THE ABDOMEN, THE SUTURE WAS MISSING ON THE UTERUS; NOT EVEN SCRAPS OF SUTURE WERE SEEN. UPON REENTRY, THERE WAS 1500 ML OF BLOOD IN THE ABDOMEN. IT WAS NOT NOTED HOW THE CASE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blood Loss; Hypovolemic Shock; Not Applicable

  MAUDE report 7642235 ↗