MONOCRYL Y732HRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031059528), received between Feb 5, 2018 and Sep 4, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE AND SUTURE WAS USED. POST-OP, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT DURING A SPAY PROCEDURE ON (B)(6). ON (B)(6) PATIENT WAS TAKEN TO EMERGENCY DUE TO TOTAL DEHISCENCE OF INCISION. CLINIC IS REQUESTING MONETARY COMPENSATION AS WELL TO HELP CLIENT OFFSET THE COST OF THE VISIT TO THE EMERGENCY CLINIC. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22964345 ↗
• MalfunctionSep 4, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE AND SUTURE WAS USED. POST-OP, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT DURING A SPAY PROCEDURE ON (B)(6). ON (B)(6), PATIENT WAS TAKEN TO EMERGENCY DUE TO TOTAL DEHISCENCE OF INCISION. CLINIC IS REQUESTING MONETARY COMPENSATION AS WELL TO HELP CLIENT OFFSET THE COST OF THE VISIT TO THE EMERGENCY CLINIC. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22964343 ↗
• MalfunctionSep 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CAME OFF OF THE NEEDLE. THE NEEDLE WAS RETRIEVED AND THE CASE WAS COMPLETED WITHOUT PATIENT HARM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182602 ↗
• MalfunctionJan 16, 2024Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, IT WAS REPORTED BY THE CUSTOMER OF FURTHER SUTURE FAILURE FROM THE SAME LOT NUMBER. ANOTHER PATIENT HERNIATED ALL HER ABDOMINAL ORGANS RESULTING IN DEATH. UNKNOWN IF DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hernia

  MAUDE report 18518875 ↗
• MalfunctionJan 16, 2024Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, IT WAS REPORTED BY THE CUSTOMER OF FURTHER SUTURE FAILURE FROM THE SAME LOT NUMBER. THE PATIENT WAS EXAMINED FOR POSSIBLE HERNIATION UNKNOWN IF DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hernia

  MAUDE report 18518874 ↗
• MalfunctionJan 12, 2024Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY OHE INCISION CLOSURE IN DECEMBER 2023. DURING THE PROCEDURE, THE SUTURE BROKE. THE SKIN SUTURE CLOSURE AND SWAGE INTACT. MUSCLE SUTURE CLOSURE BROKE IN MIDDLE, BOTH TIES ON EACH END WERE INTACT. UNKNOWN HOW THE CASE WAS COMPLETED. ABDOMINAL ORGANS HERNIATED THROUGH MUSCLE. SECOND SURGERY TO REPAIR HERNIA ONE HOUR DURATION. DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: Hernia

  MAUDE report 18502632 ↗
• MalfunctionOct 29, 2020Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. AFTER THE PROCEDURE, THE SUTURE BROKE.

  Patient problems: Wound Dehiscence

  MAUDE report 10755648 ↗
• MalfunctionNov 29, 2018Break; Break

  IT WAS REPORTED THAT A CAT UNDERWENT A SPAY PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE NEEDLE WAS NOT ATTACHED TO THE SUTURE WHEN THE PACKAGE WAS OPENED. DURING THE VISUAL INSPECTION OF THE SAMPLE, THE NEEDLE WAS FOUND BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8116574 ↗
• MalfunctionSep 5, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7845343 ↗
• MalfunctionJun 25, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE ANIMAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7634254 ↗
• MalfunctionJun 25, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE ANIMAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7634222 ↗
• MalfunctionJun 25, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE ANIMAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7634134 ↗
• MalfunctionJun 25, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE ANIMAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7634095 ↗
• MalfunctionFeb 5, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE AT THE SWAGE. 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 7241402 ↗
• MalfunctionFeb 5, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE AT THE SWAGE. 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 7241375 ↗
• MalfunctionFeb 5, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE AT THE SWAGE. 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 7241366 ↗

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.