MONOCRYL MCP427HRecalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10705031046511), received between May 9, 2019 and Sep 3, 2026 — classified as 9 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Material Separation” (28 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 52 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Total Knee Arthroplasty (TKA) procedure on (b)(6) 2026 and a barbed suture was used. Post-op, the patient experienced a wound dehiscence. The surgeon opined the product may have contributed to the wound dehiscence. Additional information was requested.

  Patient problems: Wound Dehiscence

  MAUDE report 50590497 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS THAT A PATIENT UNDERWENT A BREAST SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED AN INFECTION AROUND THE SUTURE A COUPLE OF DAYS AFTER THE PROCEDURE. THE SURGEON OPINED THIS OCCURRED AFTER CONVERTING TO TRICLOSAN-COATED PLUS SUTURES AND ATTRIBUTED THE REACTIONS/INFECTIONS TO THE TRICLOSAN-COATED PLUS SUTURE. REDNESS AND BLOTCHINESS WERE OBSERVED AROUND THE INCISION AREAS. ADDITIONAL INFORMATION IS REQUESTED.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Local Reaction; Unspecified Infection

  MAUDE report 25174697 ↗
• MalfunctionMar 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MAMMOPLASTY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE LOOSENED FROM THE WIRE DURING SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713771 ↗
• MalfunctionMar 25, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN MAMMOPLASTY SURGERY ON (B)(6) 2026 A SUTURE WAS USED. NEEDLE LOOSENED FROM THE WIRE DURING SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686142 ↗
• MalfunctionMar 25, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN MAMMOPLASTY SURGERY ON (B)(6) 2026 A SUTURE WAS USED. NEEDLE LOOSENED FROM THE WIRE DURING SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686100 ↗
• MalfunctionMar 3, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE ACCOUNT CONTACT THAT THE NEEDLE WAS NOT SECURED TO THE THREAD, AND IT DISLODGED AND LOST. THEY DID AN X-RAY AND THE NEEDLE WAS NOT FOUND IN THE PATIENT'S BODY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24494735 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT PRESENTED WITH SUTURE DEHISCENCE AND INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Unspecified Infection; Wound Dehiscence

  MAUDE report 23555693 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT (AVR) ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT PRESENTED WITH SUTURE DEHISCENCE AND INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Unspecified Infection; Wound Dehiscence

  MAUDE report 23555692 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT PRESENTED WITH SUTURE DEHISCENCE AND INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Unspecified Infection; Wound Dehiscence

  MAUDE report 23555691 ↗
• MalfunctionNov 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIORRAPHY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. PRODUCT FAILURE IN THE SURGERY ROOM OF A MONOCRYL (J&J) SUTURE, ACCORDING TO THE REPORT, THE NEEDLE IS DISASSEMBLED FROM THE THREAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496584 ↗
• MalfunctionSep 11, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED A PATIENT UNDERWENT A GYN PROCEDURE ON AN UNKNOWN DATE IN 2025 AN SUTURE WAS USED. THEY FOUND 2 SUTURES IN ONE PACKAGE WHICH IS UNUSUAL. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026121 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT REPORTED A REACTION (SWELLING) POST-SURGERY ON ABOUT (B)(6) 2025. THE REACTION STARTED WHEN THE SUTURE STARTED TO DISSOLVE. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE SUTURE WAS LEFT TO ABSORB. AS OF REPORTING DATE, THE PATIENT REPORTED THAT THE SWELLING HAS SUBSIDED, AND THE SURGERY AREA STILL HAD A SMALL LUMP BUT ONLY A LITTLE LEFT.

  Patient problems: Abscess; Local Reaction; Swelling/ Edema

  MAUDE report 23003313 ↗
• MalfunctionMar 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE TIP OF NEEDLE SNAPPED OFF DURING CLOSURE, AND THE TIP WAS SUBSEQUENTLY RETRIEVED FROM THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561645 ↗
• MalfunctionJan 31, 2025Material Separation; Material Separation

  IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT SUTURE DEGRADATION WAS OBSERVED. IT WAS REPORTED THAT SEVERAL DOCTORS EXPERIENCED TOTAL DETACHMENT OF THE NEEDLE FROM THE THREAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282776 ↗
• MalfunctionNov 20, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURES KEEP COMING OFF OF THE NEEDLE DURING USE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736544 ↗
• MalfunctionNov 20, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURES KEEP COMING OFF OF THE NEEDLE DURING USE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736330 ↗
• MalfunctionNov 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER CUSTOMER THAT THE SUTURES KEEP COMING OFF OF THE NEEDLE DURING USE. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20644836 ↗
• MalfunctionNov 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER CUSTOMER THAT THE SUTURES KEEP COMING OFF OF THE NEEDLE DURING USE. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20644069 ↗
• MalfunctionSep 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE WAS RECEIVED WITH NO COMPLAINT INFORMATION. ATTEMPTS WERE MADE TO RECONCILE THE DEVICE WITH NO SUCCESS RESULTING IN THE CREATION OF A NEW COMPLAINT. UPON VISUAL ASSESSMENT OF THE RETURNED SAMPLE, IT WAS OBSERVED THAT THE STRAND HAD BEGUN WITH A DEGRADATION PROCESS CAUSED BY EXPOSURE TO THE ENVIRONMENT. IN ADDITION, THE NEEDLE AND FOIL WERE NOT RETURNED FOR EVALUATION. THIS PRODUCT CODE CONTAINS AN ABSORBABLE SUTURE. SINCE THE SAMPLE WAS RECEIVED OPEN, THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO UNDETERMINED EXPOSURE TIME TO THE ENVIRONMENT. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20322088 ↗
• MalfunctionJul 9, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN (B)(6)2023 AND SUTURE WAS USED. THREAD LOOSENED FROM THE NEEDLE DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19700776 ↗
• MalfunctionJul 5, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN CLAVICLE SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING THE CASE, THE NEEDLE BROKE IN HALF. THEY WERE ABLE TO RETRIEVE THE PIECES OUT OF THE BODY. THE CASE WAS COMPLETED WITH A LIKE DEVICE, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19681232 ↗
• MalfunctionMay 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE IN HALF. THE EVENT OCCURRED WHEN GOING THROUGH VERY SOFT TISSUE. THEY WERE ABLE TO RETRIEVE ALL PARTS OF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299297 ↗
• MalfunctionMar 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT BREAKING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859656 ↗
• MalfunctionFeb 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED, DURING THE PROCEDURE, AT THE TIME THE SURGEON WAS SUTURING THE PATIENT'S SKIN, THE THREAD LOOSENED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18659064 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC BYPASS PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT FOR PLEE60 THERE WAS AN ISSUE WITH THE STAPLER GOING DOWN THE TROCAR AND FOR THE (B)(6), THEY HAD A HARD TIME REMOVING DEVICE FROM PACKAGING AND WHEN THEY DID, IT BROKE. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES. ONE DEVICE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080890 ↗