MONOCRYL MCP935HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031046740), received between Oct 31, 2022 and Mar 10, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY THE SALES REP THAT DURING CLOSURE, TWO NEEDLES BROKE DURING USE. THERE IS NO ADVERSE IMPACT PATIENT/USER REPORTED. 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 24559995 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY THE SALES REP THAT DURING CLOSURE, TWO NEEDLES BROKE DURING USE. THERE IS NO ADVERSE IMPACT PATIENT/USER REPORTED. 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 24559993 ↗
• MalfunctionNov 24, 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 TO THE SALES REP THAT THE SUTURE KEEP BREAKING SPECIFICALLY THE NEEDLE WAS POOPING OFF IN THE SUTURE. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT RETURN IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633438 ↗
• MalfunctionNov 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT THE SUTURE KEEP BREAKING SPECIFICALLY THE NEEDLE WAS POOPING OFF IN THE SUTURE. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT RETURN IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633432 ↗
• MalfunctionNov 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT THE SUTURE KEEP BREAKING SPECIFICALLY THE NEEDLE WAS POOPING OFF IN THE SUTURE. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT RETURN IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633401 ↗
• MalfunctionOct 31, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE STAFF SAID THE SUTURES WERE BREAKING OFF NEEDLE AND IF THEY MANAGE TO USE THE SUTURE WOULD NOT HOLD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705070 ↗
• MalfunctionOct 31, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE STAFF SAID THE SUTURES WERE BREAKING OFF NEEDLE AND IF THEY MANAGE TO USE THE SUTURE WOULD NOT HOLD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15704467 ↗