MONOCRYL MCP497GRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705031046603), received between Jun 19, 2019 and Mar 20, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Material Separation” (16 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE FELL OFF THE SUTURE FOUR DIFFERENT TIMES, LIKE FOUR DIFFERENT STRANDS THEY PULLED. THEY PULLED IT OUT OF THE CASE, THE APPEAL PACK, AND WHEN THEY WANT TO GO ARM IT, THE NEEDLE POPPED OFF. NO X-RAY WAS DONE BUT THEY WERE ABLE TO RETRIEVE THE NEEDLE. NO PATIENT CONSEQUENCES. DEVICE IS RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24648706 ↗
• MalfunctionMar 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE FELL OFF THE SUTURE FOUR DIFFERENT TIMES, LIKE FOUR DIFFERENT STRANDS THEY PULLED. THEY PULLED IT OUT OF THE CASE, THE APPEAL PACK, AND WHEN THEY WANT TO GO ARM IT, THE NEEDLE POPPED OFF. NO X-RAY WAS DONE BUT THEY WERE ABLE TO RETRIEVE THE NEEDLE. NO PATIENT CONSEQUENCES. DEVICE IS RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24648659 ↗
• MalfunctionMar 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE FELL OFF THE SUTURE FOUR DIFFERENT TIMES, LIKE FOUR DIFFERENT STRANDS THEY PULLED. THEY PULLED IT OUT OF THE CASE, THE APPEAL PACK, AND WHEN THEY WANT TO GO ARM IT, THE NEEDLE POPPED OFF. NO X-RAY WAS DONE BUT THEY WERE ABLE TO RETRIEVE THE NEEDLE. NO PATIENT CONSEQUENCES. DEVICE IS RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24648615 ↗
• MalfunctionMar 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE FELL OFF THE SUTURE FOUR DIFFERENT TIMES, LIKE FOUR DIFFERENT STRANDS THEY PULLED. THEY PULLED IT OUT OF THE CASE, THE APPEAL PACK, AND WHEN THEY WANT TO GO ARM IT, THE NEEDLE POPPED OFF. NO X-RAY WAS DONE BUT THEY WERE ABLE TO RETRIEVE THE NEEDLE. NO PATIENT CONSEQUENCES. DEVICE IS RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24648522 ↗
• MalfunctionJan 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048375 ↗
• MalfunctionJan 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048372 ↗
• MalfunctionJan 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048370 ↗
• MalfunctionJan 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048369 ↗
• MalfunctionJan 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN OPEN KNEE WOUND PROCEDURE, THE NEEDLE BROKE FROM THE SUTURE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24038003 ↗
• MalfunctionMay 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT LAPAROSCOPIC BILATERAL FALLOPIAN TUBE RECANALIZATION+HYSTEROSALPINGOSTOMY WITH METHYLENE BLUE SOLUTION+ABDOMINAL ADHESIOLYSIS ON (B)(6) 2025 AND SUTURE WAS USED. AT 09:30, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN THE SUTURE WAS USED TO SEW THE SKIN TO THE FIFTH STITCH. THE SURGEON IMMEDIATELY TOOK OUT THE BROKEN NEEDLE. AFTER CHECKING WITH THE INSTRUMENT NURSE AND THE SURGEON, THE NEEDLE BODY WAS INTACT. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY AND THE SKIN SUTURE WAS COMPLETED. THIS SITUATION CAUSED THE PATIENT'S SURGERY TO BE DELAYED BY 5 MINUTES AND REQUIRED RE-SUTURING; THE PATIENT'S INCISION IS NOW HEALING WELL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113500 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHEN SEWING . CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20897019 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHEN SEWING. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20897009 ↗
• MalfunctionMar 6, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PODIATRY PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE IN HALF WHILE SUTURING. THE NEEDLE FRAGMENT WAS RETRIEVED, AND ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18850639 ↗
• MalfunctionOct 31, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR HAD AN ISSUE USING THE SUTURE, WHICH IS A SUTURE SHE USES ALL THE TIME. THERE WAS A SECTION OF THE SUTURE THAT FELT THICKER AND SEEMED TO DRAG TISSUE WITH IT. SHE EXPLAINED IT FEELING MORE LIKE A BARBED SUTURE. A COUPLE WERE OPENED TO FEEL THE SUTURE. ONE FELT NORMAL AND ANOTHER DID FEEL LIKE IT WASN¿T UNIFORM IN SIZE. AT ONE POINT IT FELT LIKE A BUMP OR LIKE THE SUTURE BECAME BIGGER IN SIZE. ANOTHER SUTURE USED AFTER THE EVENT OCCURRED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700978 ↗
• MalfunctionOct 31, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR HAD AN ISSUE USING THE SUTURE, WHICH IS A SUTURE SHE USES ALL THE TIME. THERE WAS A SECTION OF THE SUTURE THAT FELT THICKER AND SEEMED TO DRAG TISSUE WITH IT. SHE EXPLAINED IT FEELING MORE LIKE A BARBED SUTURE. A COUPLE WERE OPENED TO FEEL THE SUTURE. ONE FELT NORMAL AND ANOTHER DID FEEL LIKE IT WASN¿T UNIFORM IN SIZE. AT ONE POINT IT FELT LIKE A BUMP OR LIKE THE SUTURE BECAME BIGGER IN SIZE. ANOTHER SUTURE USED AFTER THE EVENT OCCURRED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700969 ↗
• MalfunctionOct 31, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR HAD AN ISSUE USING THE SUTURE, WHICH IS A SUTURE SHE USES ALL THE TIME. THERE WAS A SECTION OF THE SUTURE THAT FELT THICKER AND SEEMED TO DRAG TISSUE WITH IT. SHE EXPLAINED IT FEELING MORE LIKE A BARBED SUTURE. A COUPLE WERE OPENED TO FEEL THE SUTURE. ONE FELT NORMAL AND ANOTHER DID FEEL LIKE IT WASN¿T UNIFORM IN SIZE. AT ONE POINT IT FELT LIKE A BUMP OR LIKE THE SUTURE BECAME BIGGER IN SIZE. ANOTHER SUTURE USED AFTER THE EVENT OCCURRED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700953 ↗
• MalfunctionOct 31, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR HAD AN ISSUE USING THE SUTURE, WHICH IS A SUTURE SHE USES ALL THE TIME. THERE WAS A SECTION OF THE SUTURE THAT FELT THICKER AND SEEMED TO DRAG TISSUE WITH IT. SHE EXPLAINED IT FEELING MORE LIKE A BARBED SUTURE. A COUPLE WERE OPENED TO FEEL THE SUTURE. ONE FELT NORMAL AND ANOTHER DID FEEL LIKE IT WASN¿T UNIFORM IN SIZE. AT ONE POINT IT FELT LIKE A BUMP OR LIKE THE SUTURE BECAME BIGGER IN SIZE. ANOTHER SUTURE USED AFTER THE EVENT OCCURRED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700945 ↗
• MalfunctionOct 31, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR HAD AN ISSUE USING THE SUTURE, WHICH IS A SUTURE SHE USES ALL THE TIME. THERE WAS A SECTION OF THE SUTURE THAT FELT THICKER AND SEEMED TO DRAG TISSUE WITH IT. SHE EXPLAINED IT FEELING MORE LIKE A BARBED SUTURE. A COUPLE WERE OPENED TO FEEL THE SUTURE. ONE FELT NORMAL AND ANOTHER DID FEEL LIKE IT WASN¿T UNIFORM IN SIZE. AT ONE POINT IT FELT LIKE A BUMP OR LIKE THE SUTURE BECAME BIGGER IN SIZE. ANOTHER SUTURE USED AFTER THE EVENT OCCURRED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700936 ↗
• MalfunctionOct 31, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR HAD AN ISSUE USING THE SUTURE, WHICH IS A SUTURE SHE USES ALL THE TIME. THERE WAS A SECTION OF THE SUTURE THAT FELT THICKER AND SEEMED TO DRAG TISSUE WITH IT. SHE EXPLAINED IT FEELING MORE LIKE A BARBED SUTURE. A COUPLE WERE OPENED TO FEEL THE SUTURE. ONE FELT NORMAL AND ANOTHER DID FEEL LIKE IT WASN¿T UNIFORM IN SIZE. AT ONE POINT IT FELT LIKE A BUMP OR LIKE THE SUTURE BECAME BIGGER IN SIZE. ANOTHER SUTURE USED AFTER THE EVENT OCCURRED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700921 ↗
• MalfunctionOct 11, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OBSTETRIC PROCEDURE ON (B)(6) 2021 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN USED. ANOTHER LIKE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12608280 ↗
• MalfunctionOct 21, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED THE END OF THE SUTURE. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9213541 ↗
• MalfunctionOct 21, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE,THE NEEDLE BROKE WHERE THEY WERE ARMING IT. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9213540 ↗
• MalfunctionAug 8, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE BECAME DETACHED FROM THE SUTURE MATERIAL DURING USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8875855 ↗
• MalfunctionJun 19, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE THREAD BROKE AWAY FROM NEEDLE AT SWAGE WITH SKIN CLOSURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712083 ↗
• MalfunctionJun 19, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE THREAD BROKE AWAY FROM NEEDLE AT SWAGE WITH SKIN CLOSURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712081 ↗