MONOCRYL Y214HRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10705031058576), received between Feb 25, 2019 and Mar 13, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Material Separation” (22 reports).

2 other recalls cover devices cleared under the same FDA submission (K964072); they may or may not involve this specific model.

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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT SUTURE DEGRADATION WAS OBSERVED. IT WAS REPORTED THAT THE NEEDLE HAD BEEN FOUND BROKEN IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590706 ↗
• MalfunctionMay 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A XR RADICAL CYSTECTOMY WITH ILEAL CONDUIT AND LYMPH NODE DISSECTION PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM, #MW (B)(4) THE TIP OF NEEDLE BROKE WHILE IN PATIENT, MD (MEDICAL DOCTOR) ABLE TO RECOVER TIP AND REMOVE FROM PATIENT. 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 22056174 ↗
• MalfunctionApr 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT NEEDLE CAME OFF FROM SUTURE DURING A SURGERY. DOCTOR HAD TO RECOVER NEEDLE FROM PATIENT, RESULTING IN TISSUE TRAUMA. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21820039 ↗
• MalfunctionJul 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP CHOLECYSTECTOMY ON 20-JUN-2025 AND SUTURE WAS USED TO CLOSE THE SKIN. DURING THE PROCEDURE, UPON MAKING FIRST PASS, THE NEEDLE BROKE. THE SURGEON WAS ABLE TO REMOVE ALL NEEDLE FRAGMENTS AND HAD THE STAFF OPEN A NEW SUTURE TO FINISH THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19801565 ↗
• MalfunctionMay 11, 2023Material Separation; Tear, Rip or Hole in Device Packaging; Material Separation; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16915792 ↗
• MalfunctionDec 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE SEPARATED FROM THE NEEDLE WITHOUT USING MUCH FORCE. NO PARTS FELL INTO THE SITUS AND THERE WAS NO DELAY IN SURGERY. A LIKE DEVICE WAS USED 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 12981794 ↗
• MalfunctionDec 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE SEPARATED FROM THE NEEDLE WITHOUT USING MUCH FORCE. NO PARTS FELL INTO THE SITUS AND THERE WAS NO DELAY IN SURGERY. A LIKE DEVICE WAS USED 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 12981793 ↗
• MalfunctionDec 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE SEPARATED FROM THE NEEDLE WITHOUT USING MUCH FORCE. NO PARTS FELL INTO THE SITUS AND THERE WAS NO DELAY IN SURGERY. A LIKE DEVICE WAS USED 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 12981792 ↗
• MalfunctionDec 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE SEPARATED FROM THE NEEDLE WITHOUT USING MUCH FORCE. NO PARTS FELL INTO THE SITUS AND THERE WAS NO DELAY IN SURGERY. A LIKE DEVICE WAS USED 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 12981791 ↗
• MalfunctionDec 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE SEPARATED FROM THE NEEDLE WITHOUT USING MUCH FORCE. NO PARTS FELL INTO THE SITUS AND THERE WAS NO DELAY IN SURGERY. A LIKE DEVICE WAS USED 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 12981789 ↗
• MalfunctionDec 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE SEPARATED FROM THE NEEDLE WITHOUT USING MUCH FORCE. NO PARTS FELL INTO THE SITUS AND THERE WAS NO DELAY IN SURGERY. A LIKE DEVICE WAS USED 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 12981788 ↗
• MalfunctionDec 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE SEPARATED FROM THE NEEDLE WITHOUT USING MUCH FORCE. NO PARTS FELL INTO THE SITUS AND THERE WAS NO DELAY IN SURGERY. A LIKE DEVICE WAS USED 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 12981787 ↗
• MalfunctionDec 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE SEPARATED FROM THE NEEDLE WITHOUT USING MUCH FORCE. NO PARTS FELL INTO THE SITUS AND THERE WAS NO DELAY IN SURGERY. A LIKE DEVICE WAS USED 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 12981786 ↗
• MalfunctionDec 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE SEPARATED FROM THE NEEDLE WITHOUT USING MUCH FORCE. NO PARTS FELL INTO THE SITUS AND THERE WAS NO DELAY IN SURGERY. A LIKE DEVICE WAS USED 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 12981785 ↗
• MalfunctionDec 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE SEPARATED FROM THE NEEDLE WITHOUT USING MUCH FORCE. NO PARTS FELL INTO THE SITUS AND THERE WAS NO DELAY IN SURGERY. A LIKE DEVICE WAS USED 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 12981784 ↗
• MalfunctionDec 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE SEPARATED FROM THE NEEDLE WITHOUT USING MUCH FORCE. NO PARTS FELL INTO THE SITUS AND THERE WAS NO DELAY IN SURGERY. A LIKE DEVICE WAS USED 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 12981783 ↗
• MalfunctionMar 12, 2019Material Separation; Tear, Rip or Hole in Device Packaging; Material Separation; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTROINTESTINAL ANASTOMOSIS SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF WHEN SEWING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8414544 ↗
• MalfunctionMar 12, 2019Material Separation; Tear, Rip or Hole in Device Packaging; Material Separation; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTROINTESTINAL ANASTOMOSIS SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF WHEN SEWING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8414541 ↗
• MalfunctionMar 12, 2019Material Separation; Tear, Rip or Hole in Device Packaging; Material Separation; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTROINTESTINAL ANASTOMOSIS SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF WHEN SEWING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8414539 ↗
• MalfunctionMar 12, 2019Material Separation; Tear, Rip or Hole in Device Packaging; Material Separation; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTROINTESTINAL ANASTOMOSIS SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF WHEN SEWING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8413651 ↗
• MalfunctionMar 12, 2019Material Separation; Tear, Rip or Hole in Device Packaging; Material Separation; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTROINTESTINAL ANASTOMOSIS SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF WHEN SEWING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8413646 ↗
• MalfunctionMar 12, 2019Material Separation; Tear, Rip or Hole in Device Packaging; Material Separation; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTROINTESTINAL ANASTOMOSIS SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF WHEN SEWING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8413645 ↗
• MalfunctionFeb 25, 2019Material Separation; Tear, Rip or Hole in Device Packaging; Material Separation; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTROINTESTINAL ANASTOMOSIS SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF WHEN SEWING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8367114 ↗
• MalfunctionFeb 25, 2019Material Separation; Tear, Rip or Hole in Device Packaging; Material Separation; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTROINTESTINAL ANASTOMOSIS SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF WHEN SEWING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8366792 ↗
• MalfunctionFeb 25, 2019Material Separation; Tear, Rip or Hole in Device Packaging; Material Separation; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTROINTESTINAL ANASTOMOSIS SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF WHEN SEWING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8366791 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964072. One submission often covers many models, so check the product and lot details in each record.

• Z-0487-2025 · Oct 8, 2024 · Open, Classified
  MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and
• Z-2148-2024 · May 10, 2024 · Open, Classified
  MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345