MONOCRYL MCP494GRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705031046573), received between Sep 6, 2019 and Jan 13, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Break” (20 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT ALMOST EVERY SUTURE FROM THIS BOX COME OFF FROM THE NEEDLE, WITHOUT LITTLE TO NO PRESSURE OR MANEUVER. NO INJURIES OR ADVERSE EVENT IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052573 ↗
• MalfunctionDec 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AT THE SWAGE AREA. THE NEEDLE DID NOT DETACH FROM SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935280 ↗
• MalfunctionJun 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WAS ALERTED BY CLINIC NURSE <NURSE'S NAME>THAT THERE WERE 2 SUTURES THAT DETACHED FROM THE NEEDLE. DR <DOCTOR'S NAME>WAS CLOSING THE SKIN LAYER WITH THE SUTURE DURING THE END OF THE BREAST SURGERY. A 3RD PIECE WAS OPENED TO CONTINUE WITH THE PROCEDURE. ONLY THE 2ND FAULTY SUTURE WAS RETAINED AS THEY HAD DISCARDED THE 1ST SUTURE. CLINIC STILL HAS 25 PCS OF SUTURE WITH THE SAME LOT NUMBER TO BE RETURNED AND EXCHANGED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309857 ↗
• MalfunctionJun 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WAS ALERTED BY CLINIC NURSE <NURSE'S NAME>THAT THERE WERE 2 SUTURES THAT DETACHED FROM THE NEEDLE. DR <DOCTOR'S NAME>WAS CLOSING THE SKIN LAYER WITH THE SUTURE DURING THE END OF THE BREAST SURGERY. A 3RD PIECE WAS OPENED TO CONTINUE WITH THE PROCEDURE. ONLY THE 2ND FAULTY SUTURE WAS RETAINED AS THEY HAD DISCARDED THE 1ST SUTURE. CLINIC STILL HAS 25 PCS OF SUTURE WITH THE SAME LOT NUMBER TO BE RETURNED AND EXCHANGED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309853 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THE PRODUCT FELL APART WITHIN HOURS. DEVICES ARE AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043451 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THE PRODUCT FELL APART WITHIN HOURS. DEVICES ARE AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043449 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED BY THE DISTRIBUTOR THE PRODUCT FELL APART WITHIN HOURS. NO PATIENT CONSEQUENCE WAS REPORTED. DEVICES ARE AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043401 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THE PRODUCT FELL APART WITHIN HOURS. DEVICES ARE AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043394 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THE PRODUCT FELL APART WITHIN HOURS. DEVICES ARE AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043368 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THE PRODUCT FELL APART WITHIN HOURS. DEVICES ARE AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043363 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THE PRODUCT FELL APART WITHIN HOURS. DEVICES ARE AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043360 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THE PRODUCT FELL APART WITHIN HOURS. DEVICES ARE AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043359 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THE PRODUCT FELL APART WITHIN HOURS. DEVICES ARE AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043358 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THE PRODUCT FELL APART WITHIN HOURS. DEVICES ARE AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043238 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THE PRODUCT FELL APART WITHIN HOURS. DEVICES ARE AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043221 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THE PRODUCT FELL APART WITHIN HOURS. DEVICES ARE AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043206 ↗
• MalfunctionJun 6, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURE SNAPPED EVEN BEFORE TAKING THE FIRST BITE. A SUBSEQUENT SUTURE WAS OPENED AND THERE WERE NO FURTHER ISSUES. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT, AND THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19478437 ↗
• MalfunctionFeb 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE DETACHED FROM THE NEEDLE DURING SKIN CLOSURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18760626 ↗
• MalfunctionFeb 21, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748154 ↗
• MalfunctionOct 13, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE SUTURE'S NEEDLE BROKE INTO 2 PIECES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931825 ↗
• MalfunctionOct 13, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE SUTURE BROKE APART INTRA-OP. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931822 ↗
• MalfunctionOct 13, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE SUTURE BROKE APART INTRA-OP. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931812 ↗
• MalfunctionMay 25, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN CANCER EXCISION PROCEDURE ON 05/04/2022 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO LOTS OF SUTURES FROM BATCH MCP494 BROKE DURING USE. IN BOTH CASES THE NEEDLE SNAPPED OFF FROM THE SUTURE MATERIAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14499068 ↗
• MalfunctionMay 25, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN CANCER EXCISION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO LOTS OF SUTURES FROM BATCH MCP494 BROKE DURING USE. IN BOTH CASES THE NEEDLE SNAPPED OFF FROM THE SUTURE MATERIAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14498837 ↗
• MalfunctionOct 28, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2019 AND SUTURE WAS USED ON THE SKIN. DURING THE PROCEDURE, THE SUTURE WAS BEING USED TO SUTURE SKIN AND A MAJORITY OF THE NEEDLE BROKE OFF UNDER THE SKIN. PART OF THE NEEDLE WAS STILL ON THE SUTURE. CLOSING WAS DELAYED TO GET THE NEEDLE OUT. THE PATIENT'S TREATMENT WAS NOT ALTERED IN ANYWAY DUE TO THE PROLONGED SURGERY TIME THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9244403 ↗