MONOCRYL Y305HRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705031058712), received between May 9, 2018 and Mar 16, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Material Separation” (13 reports).

2 other recalls cover devices cleared under the same FDA submission (K960653); 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS THAT THE SUTURES BROKE DURING SURGERY. THEY OPENED ANOTHER BOX AND NONE OF THOSE BROKE. THERE IS NO ADVERSE IMPACT PATIENT/USER REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604077 ↗
• MalfunctionMar 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS THAT THE SUTURES BROKE DURING SURGERY. THEY OPENED ANOTHER BOX AND NONE OF THOSE BROKE. THERE IS NO ADVERSE IMPACT PATIENT/USER REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604047 ↗
• MalfunctionMar 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS THAT THE SUTURES BROKE DURING SURGERY. THEY OPENED ANOTHER BOX AND NONE OF THOSE BROKE. THERE IS NO ADVERSE IMPACT PATIENT/USER REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604046 ↗
• MalfunctionMar 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGY DA VINCI PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, WHEN ONE PACKAGE WAS OPENED, THE SUTURE AND NEEDLE WERE CUT OFF LIKE A CONTROL RELEASE NEEDLE. IT WAS NOTICED BEFORE USE, SO ANOTHER PRODUCT WAS USED AS A REPLACEMENT. IT WAS NOT A CONTROL RELEASE NEEDLE. DURING VISUAL INSPECTION OF THE DETACHED NEEDLE, THE SWAGE AND ATTACHMENT AREA WAS NOTED TO BE AS EXPECTED. THE BARREL HOLE WAS EXAMINED, AND REMNANT OF SUTURE WAS OBSERVED. THE SUTURE CANNOT BE DISPENSED SINCE HAVE BEGUN THE DEGRADATION PROCESS THIS CONDITION PROBABLY CAUSED THE DETACHED NEEDLE. THE TIME OF EXPOSURE OF THE SUTURE TO THE ENVIRONMENT COULD NOT BE DETERMINED. PER THE SAMPLE CONDITION, THE FUNCTIONAL TEST CANNOT BE PERFORMED. THE FOIL WAS VISUALLY INSPECTED, AND NO ANOMALIES WERE OBSERVED DURING THE EVALUATION. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689919 ↗
• MalfunctionFeb 10, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE CLINIC ORDERED Y316H BUT UPON OPENING THE PRODUCT PACKAGING, THE CLINIC FOUND INDIVIDUAL PACKETS OF Y30 TO BE CONTAINED WITHIN THE PACKAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349220 ↗
• MalfunctionOct 1, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FEMORAL ENDARTERECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING A FEMORAL ENDARTERECTOMY, WHEN USING THE SUTURE, DOCTOR STATED IT FELT "JANKY", SUTURE HAD MICRO FRACTURES IN THE SUTURE LINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343858 ↗
• MalfunctionSep 30, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE CLINIC ORDERED Y316H BUT UPON OPENING THE PRODUCT PACKAGING, THE CLINIC FOUND INDIVIDUAL PACKETS OF Y30 TO BE CONTAINED WITHIN THE PACKAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20337812 ↗
• MalfunctionSep 18, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY, IT WAS NOT A CONTROL RELEASE NEEDLE. THE SUTURE HAD CUT WHEN THE SUTURE WAS TIED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251305 ↗
• MalfunctionJul 25, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. A SUTURE HAD BEEN MIXED IN WITH A DIFFERENT TYPE OF SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19830881 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A ROBOTIC PROSTATECTOMY PROCEDURE ON (B)(6) 2024, AND SUTURE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THREE SUTURES BROKE WHILE SUTURING. ONE STRATAFIX DURING THE URETHROVESICLE ANASTOMOSIS, ONE MONOCRYL DURING THE OVER SEW OF THE CONNECTION BETWEEN THE URETHRA AND THE BLADDER, AND A DYED MONOCRYL WHILE SUTURING THE OTHER SIDE OF THE ANASTOMOSIS OVER SEW BETWEEN THE URETHRA AND THE BLADDER. FOR EACH, ANOTHER SUTURE WAS USED TO CONTINUE WITH THE PROCEDURE. LEAK TEST WAS PREFORMED AND NO LEAKS WERE FOUND. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FURTHER REPORTED ISSUES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838632 ↗
• MalfunctionJan 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, WHEN THE NEEDLE WAS APPLIED AT THE TISSUE, THE SUTURE WAS DETACHED FROM THE NEEDLE AT SWAGE PART. IT WAS FELL INTO THE PATIENT¿S BODY FOR A MOMENT, BUT IT WAS FOUND AND RETRIEVED IMMEDIATELY DURING THE SURGERY AND THERE WAS NO PROBLEM. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438360 ↗
• MalfunctionJan 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, WHEN THE NEEDLE WAS APPLIED AT THE TISSUE, THE SUTURE WAS DETACHED FROM THE NEEDLE AT SWAGE PART. IT WAS FELL INTO THE PATIENT¿S BODY FOR A MOMENT, BUT IT WAS FOUND AND RETRIEVED IMMEDIATELY DURING THE SURGERY AND THERE WAS NO PROBLEM. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438315 ↗
• MalfunctionJul 7, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE UNKNOWN SURGERY USING DA VINCI SURGICAL SYSTEM, THE NEEDLE WAS BROKEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278662 ↗
• MalfunctionMar 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGICAL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING CONTINUOUS SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16625304 ↗
• MalfunctionAug 3, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY ON AN UNKNOWN DATE AND THE SUTURE WAS USED. DURING SURGERY, THE SURGEON PULLED THE NEEDLE LIGHTLY AND THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15160530 ↗
• MalfunctionJan 6, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PEDIATRIC SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13179480 ↗
• MalfunctionDec 2, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, NG TO PUT THE NEEDLE-SUTURE THROUGH A TROCAR AFTER THE NEEDLE WAS GRASPED WITH A NEEDLE-HOLDER, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916087 ↗
• MalfunctionSep 7, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE SEPARATED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12433621 ↗
• MalfunctionJan 11, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC TOTAL PROSTATECTOMY ON (B)(6) 2020 AND SUTURE WAS USED. DURING CONTINUOUS SUTURING ON THE URINARY DUCT, THE NEEDLE WAS DETACHED FROM THE SUTURE IN THE ABDOMINAL CAVITY. IT WAS NOT A CONTROL RELEASE NEEDLE. THE NEEDLE WAS REMOVED WITHOUT LOSING SIGHT OF IT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11151755 ↗
• MalfunctionAug 11, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC-ASSISTED TOTAL PROSTATECTOMY PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE SURGERY, WHEN PASSING THE NEEDLE THROUGH THE SANTORINI'S VEIN LAYER AT THE 1ST STITCH, THE NEEDLE WAS DETACHED FROM THE SUTURE. THE NEEDLE WAS ON THE TISSUE AT THAT TIME, SO IT WAS NOT LOST. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10390295 ↗
• MalfunctionJul 27, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL PROSTATECTOMY PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF THE SUTURE DURING USE ON THE URETER. IT WAS NOT A CONTROL RELEASE NEEDLE. IT WAS HARD FINDING THE NEEDLE THAT CAME OFF. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10325996 ↗
• MalfunctionJun 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF OF THE SUTURE WHEN CLOSING. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10162279 ↗
• MalfunctionJun 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME OFF OF THE SUTURE WHEN CLOSING. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10162278 ↗
• MalfunctionSep 17, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL CYSTECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE DETACHED FROM THE SUTURE DURING CONTINUOUS SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS WERE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9076323 ↗
• MalfunctionMar 6, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOT-ASSISTED LAPAROSCOPIC PROSTATECTOMY WITH DA VINCI ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN PULLING THE SUTURE DURING URETHRAL ANASTOMOSIS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8394353 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K960653. One submission often covers many models, so check the product and lot details in each record.

• 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
• Z-1311-2009 · Feb 2, 2009 · Terminated
  MONOCRYL (poliglecaprone 25 ) Suture, Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and/or ligation.