MONOCRYL MCP426HRecalls & reported problems

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 10705031046504), received between May 16, 2018 and Sep 8, 2026 — classified as 23 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Break” (100 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 10, 2024Open, Classified

   Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

   Z-2149-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 139 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Break

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. During the procedure, the needle broke off. No patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50667989 ↗
• MalfunctionJul 31, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50101399 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, AS THE DOCTOR AND PA WERE CLOSING ON THE CASE, THEY REALIZED THAT THE VERY END OF THE SUTURE NEEDLE HAD BROKEN OFF AND WAS MISSING. THEY ORDERED AN XRAY TO DOUBLE CHECK THAT THERE WAS NO FOREIGN OBJECTS IN THE PATIENT. PER THE DOCTOR AND THE RADIOLOGIST THERE WAS NOTHING LEFT IN THE PATIENT. IT DID NOT CAUSE HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE DEVICE WAS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933694 ↗
• MalfunctionApr 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE BROKE ON THE FIRST USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847652 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BEGAN BREAKING MID-STITCH, WHILE IN PATIENT TISSUE. PA AND ST ABLE TO RETRIEVE ALL PIECES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313808 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT DURING A GYNECOLOGICAL PROCEDURE, WHILE PERFORMING SKIN CLOSURE, THE TIP OF THE NEEDLE BROKE OFF. AN X-RAY WAS PERFORMED ON THE PATIENT TO LOCATE THE BROKEN PIECE OF THE NEEDLE. THE X-RAY WAS REVIEWED AND CLEARED BY THE SURGEON. 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 24282701 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE REMOVAL OF SOFT TISSUE MASS SURGERY, THE TIP OF THE NEEDLE BROKE OFF. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067245 ↗
• MalfunctionDec 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. CUSTOMER REPORTS THAT THE SUTURE THREAD DETACHES FROM THE NEEDLE AFTER ONE TO TWO SUTURES. ISSUE HAS OCCURRED ACROSS MULTIPLE PROCEDURES AND SURGEONS, LEADING TO PROCEDURAL DELAYS AND PRODUCT WASTAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742670 ↗
• MalfunctionDec 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, CUSTOMER REPORTS THAT THE SUTURE THREAD DETACHES FROM THE NEEDLE AFTER ONE TO TWO SUTURES. ISSUE HAS OCCURRED ACROSS MULTIPLE PROCEDURES AND SURGEONS, LEADING TO PROCEDURAL DELAYS AND PRODUCT WASTAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23719851 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REPRESENTATIVE REPORTED THAT DURING AN OPEN INGUINAL HERNIA PROCEDURE, THE SUTURE BROKE AS THE SURGICAL ASSISTANT WAS CLOSING THE WOUND. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425598 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NURSE GAVE THE DOCTOR THE SUTURE FOR CONTINUOUS SUTURE OF SKIN ACCORDING TO THE DOCTOR'S REQUEST DURING SURGERY. AFTER SEVERAL STITCHES WERE SUTURED, THE SUTURE SUDDENLY BROKE. THE DOCTOR QUICKLY REQUESTED TO USE A REGULAR TRIANGULAR NEEDLE TO THREAD THE BROKEN SUTURE AND FINISH SUTURING IT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300861 ↗
• MalfunctionAug 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DISASSEMBLED AS IT PASSED THROUGH THE TISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809605 ↗
• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT, WHEN THE SURGEON WAS USING THE NEEDLE, THE TIP SNAPPED IN HALF FROM THE NEEDLE ITSELF. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730462 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEPHRECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A PARTIAL ROBOTIC NEPHRECTOMY PROCEDURE THAT DURING CLOSURE THE SUTURE BROKE WHILE TYING KNOTS. ANOTHER SUTURE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918070 ↗
• MalfunctionFeb 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326780 ↗
• MalfunctionJan 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6) 2024 AND A SUTURE WAS USED. THE NEEDLE BROKE DURING SKIN CLOSURE. FRAGMENT WAS NOT RECOVERED. NO X-RAY WAS DONE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172963 ↗
• MalfunctionSep 18, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF BREAST MASS PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, AS THE SURGEON WAS ABOUT TO CLOSE THE EXCISION, THE SUTURE SUDDENLY SNAPPED LEAVING THE NEEDLE IN THE SKIN. ANY SURGICAL DELAY WAS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245353 ↗
• MalfunctionSep 18, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF BREAST MASS PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, AS THE SURGEON WAS ABOUT TO CLOSE THE EXCISION, THE SUTURE SUDDENLY SNAPPED LEAVING THE NEEDLE IN THE SKIN. ANY SURGICAL DELAY WAS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245350 ↗
• MalfunctionSep 18, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF BREAST MASS PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, AS THE SURGEON WAS ABOUT TO CLOSE THE EXCISION, THE SUTURE SUDDENLY SNAPPED LEAVING THE NEEDLE IN THE SKIN. ANY SURGICAL DELAY WAS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245341 ↗
• MalfunctionSep 18, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF BREAST MASS PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, AS THE SURGEON WAS ABOUT TO CLOSE THE EXCISION, THE SUTURE SUDDENLY SNAPPED LEAVING THE NEEDLE IN THE SKIN. ANY SURGICAL DELAY WAS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245340 ↗
• MalfunctionSep 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD WAS DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20216389 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMPECTOMY WITH BIOPSY SENTINEL NODES PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SUTURE WAS ATTEMPTED TO BE REMOVED FROM THE PACKET THE SUTURE WOULD EITHER BREAK OR STRETCH AND BECOME WEAK AND BREAK ON THE FIRST PASS THROUGH TISSUE. ANOTHER LIKE DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924176 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SUTURE WAS ATTEMPTED TO BE REMOVED FROM THE PACKET THE SUTURE WOULD EITHER BREAK OR STRETCH AND BECOME WEAK AND BREAK ON THE FIRST PASS THROUGH TISSUE. ANOTHER LIKE DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924104 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMPECTOMY WITH BIOPSY SENTINEL NODES PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SUTURE WAS ATTEMPTED TO BE REMOVED FROM THE PACKET THE SUTURE WOULD EITHER BREAK OR STRETCH AND BECOME WEAK AND BREAK ON THE FIRST PASS THROUGH TISSUE. ANOTHER LIKE DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924059 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMPECTOMY WITH BIOPSY SENTINEL NODES PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SUTURE WAS ATTEMPTED TO BE REMOVED FROM THE PACKET THE SUTURE WOULD EITHER BREAK OR STRETCH AND BECOME WEAK AND BREAK ON THE FIRST PASS THROUGH TISSUE. ANOTHER LIKE DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19923841 ↗