MONOCRYL MCP345HRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031046429), received between Jun 22, 2020 and Apr 20, 2026 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Break; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT SUTURE IS NOT 19MM THAT WAS WITHIN THE PACKAGING. POSSIBLE MANUFACTURER ISSUE WHERE THE OUTSIDE PACKAGING SAYS ONE (MM) SIZE WHILE INSIDE THE PRODUCT IS DIFFERENT (MM). IN ADDITION, BREAKING IS COMMON AND THE SUTURE IS NOT STAYING WITHIN. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925358 ↗
• MalfunctionApr 20, 2026Break; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT SUTURE IS NOT 19MM THAT WAS WITHIN THE PACKAGING. POSSIBLE MANUFACTURER ISSUE WHERE THE OUTSIDE PACKAGING SAYS ONE (MM) SIZE WHILE INSIDE THE PRODUCT IS DIFFERENT (MM). IN ADDITION, BREAKING IS COMMON AND THE SUTURE IS NOT STAYING WITHIN. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925293 ↗
• MalfunctionApr 2, 2026Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT SHORT INSERTION WAS OBSERVED. IN THE OPERATING ROOM PROCEDURE IN CHARGE OF DOCTOR, WHEN OPENING THE DEVICE IT IS SEEN THAT THE SUTURE IS NOT PLACED IN THE NEEDLE, WHICH IS WHY ANOTHER DEVICE IS REQUESTED FROM THE HOSPITAL PHARMACY AND MEDICAL SUPPLIES AND IS REPLACED AT THE SAME TIME. BIOMEDICAL PERSONNEL WENT TO THE OPERATING ROOM WHO VERIFIED THAT THE FAILURE OF THE MEDICAL DEVICE OCCURRED PRIOR TO ITS USE WITH THE PATIENT, DETERMINING THAT IT WAS A QUASI-FAILURE SINCE IT DID NOT CAUSE HARM TO THE PATIENT. THE MEDICAL DEVICE WAS REVIEWED TO POSSIBLY IDENTIFY IF THE FAILURE OF ITS OPERATION WAS ASSOCIATED WITH IMPROPER STORAGE, HANDLING OR FACTORY DEFECTS. ROOT CAUSE: DEVICE WITH A FACTORY DEFECT. THERE WERE NO SIGNIFICANT DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769255 ↗
• MalfunctionMar 16, 2026Break; Device Markings/Labelling Problem; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURE IS NOT 19MM THAT WAS WITHIN THE PACKAGING. POSSIBLE MANUFACTURER ISSUE WHERE THE OUTSIDE PACKAGING SAYS ONE (MM) SIZE WHILE INSIDE THE PRODUCT IS DIFFERENT (MM). IN ADDITION, BREAKING IS COMMON AND THE SUTURE IS NOT STAYING WITHIN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604152 ↗
• MalfunctionFeb 25, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2026 AND SUTURE WAS USED. THE SURGEON HAD A NEEDLE PULL OFF THE SUTURE WITH A SMALL PULL. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442076 ↗
• MalfunctionFeb 25, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2026 AND SUTURE WAS USED. THE SURGEON HAD A NEEDLE PULL OFF THE SUTURE WITH A SMALL PULL. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442066 ↗
• MalfunctionFeb 25, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2026 AND SUTURE WAS USED. THE SURGEON HAD A NEEDLE PULL OFF THE SUTURE WITH A SMALL PULL. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442065 ↗
• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. SEVERAL PACKS FROM THIS LOT BROKE OFF AT THE NEEDLE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21723602 ↗
• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. SEVERAL PACKS FROM THIS LOT BROKE OFF AT THE NEEDLE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21723544 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED THAT A DOG UNDERWENT AN UNSPECIFIED PROCEDURE IN 2024 AND SUTURE WAS USED. WITHIN ABOUT 3 DAYS, THE DOG WAS SEEN BY THE EMERGENCY CLINIC. THE ORIGINAL SURGEON SPOKE WITH THE DOCTOR WHO SAID THAT THE INCISION WAS OPEN. IT HAD DEHISCED AND WHEN THEY OPENED THE DOG UP, THERE WERE BLOOD CLOTS AND THEY HAD REMOVE THE SPLEEN. THE SUTURE DID BREAK POST OP BECAUSE THE INCISION WAS OPEN. THE DOG WAS SEEN 1 WEEK POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 20262871 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED THAT A DOG UNDERWENT AN UNSPECIFIED PROCEDURE AND SUTURE WAS USED. THE FIRST SURGERY WAS ON THURSDAY, AND BY MONDAY THEY BROUGHT THE DOG BACK IN AND THE SUTURE SITE HAD DEHISCED. THE DOG WAS SENT TO THE EMERGENCY CLINIC AND THE DOCTORS SAID ALL THREE LAYERS HAD COME UNDONE/OPEN AND THE STOMACH WAS FILLED WITH FLUID AND PUSS. THE SUTURE DID BREAK POST OP BECAUSE THE INCISION WAS OPEN. THE DOG WAS SEEN 4 DAYS POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Purulent Discharge; Wound Dehiscence

  MAUDE report 20260536 ↗
• MalfunctionJun 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A CANINE UNDERWENT A OVARIOHYSTERECTOMY AND SUTURE WAS USED. THE DOCTOR GRASPED NEEDLE AND THERE WAS NO SUTURE ATTACHED. ANOTHER SUTURE WAS USED. UPON RETURN OF THE DEVICE AND EVALUATION, THE BARREL HOLE OF THE NEEDLE WAS EXAMINED UNDER MAGNIFICATION AND NO SUTURE REMNANT WAS NOTED. THE SUTURE WAS EXAMINED, AND THE INSERTION DID NOT MEET THE REQUIREMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10180137 ↗