MONOCRYL Y317HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031058767), received between Dec 5, 2018 and Mar 26, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGERY AT 9:00. DURING THE OPERATION, THE DOCTOR USED A SUTURE AND FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND COULD NOT BE USED. THE DOCTOR IMMEDIATELY REPLACED THE SUTURE WITH A NEW ONE TO CONTINUE THE SURGERY. THE NEWLY REPLACED SUTURE WAS USED SMOOTHLY WITHOUT ANY ABNORMAL SITUATIONS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705675 ↗
• MalfunctionDec 22, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE SUTURES FROM THIS BOX ARE BREAKING OFF OF THE NEEDLE WHILE WE ARE IN SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383662 ↗
• MalfunctionDec 22, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE SUTURES FROM THIS BOX ARE BREAKING OFF OF THE NEEDLE WHILE WE ARE IN SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383661 ↗
• MalfunctionJun 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE TOWARDS THE SHAFT DURING SUTURING. THE NEEDLE TOOK 40MINS TO LOCATE FROM WITHIN THE PATIENT USING XRAY AND THE SURGERY WAS DELAYED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14705017 ↗
• MalfunctionApr 27, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222675 ↗
• MalfunctionApr 27, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222243 ↗
• MalfunctionApr 27, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222139 ↗
• MalfunctionApr 26, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14214771 ↗
• InjuryFeb 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: "MYOMECTOMY SCAR ECTOPIC PREGNANCY FOLLOWING A CRYOPRESERVED EMBRYO TRANSFER," TATSUYA ISHIGURO, KAORU YAMAWAKI, MAKOTO CHIHARA, NOBUMICHI NISHIKAWA, TAKAYUKI ENOMOTO, 2018 VOLUME 17, PAGES 509-513. CASE: A (B)(6) WOMAN WITH A HISTORY OF A MYOMECTOMY VISITED THE DEPARTMENT OF OBSTETRICS AND GYNECOLOGY, (B)(6) UNIVERSITY MEDICAL AND DENTAL HOSPITAL, (B)(6), FOLLOWING 2 YEARS OF INFERTILITY. MAGNETIC RESONANCE IMAGING DETECTED AN ABNORMAL ENDOMETRIAL-LIKE PSEUDO-CAVITY. A HYSTEROSALPINGOGRAPHY ALSO REVEALED AN ABNORMAL ACCUMULATION OF CONTRAST MEDIUM AT THE MYOMETRIAL SCAR SITE. A TRANSVAGINAL ULTRASOUND SHOWED A THIN MYOMETRIUM AT THE LOWER UTERINE BODY. THE PATIENT CONCEIVED VIA IN VITRO FERTILIZATION UNDER A LUTEAL PHASE DOWN- REGULATION PROTOCOL (LONG PROTOCOL) FOR CONTROLLED OVARIAN STIMULATION, FOLLOWED BY A CRYOPRESERVED EMBRYO TRANSFER DURING HER NATURAL OVULATION CYCLE. AFTER THE EMBRYO TRANSFER, THE GESTATIONAL SAC WAS LOCATED AT THE SUBSEROSAL SITE OF THE MYOMECTOMY SCAR. OUTCOME: AN EMERGENT LAPAROSCOPIC OPERATION WAS PERFORMED AND THE EMBRYO WAS REMOVED SUCCESSFULLY VIA LAPAROSCOPY UNDER TRANSVAGINAL ULTRASONOGRAPHY. CONCLUSION: A SUB

  Patient problems: Fistula

  MAUDE report 8339206 ↗
• MalfunctionDec 13, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND A SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS FOUND TO BE DEFECTIVE AS THE THREAD DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8162000 ↗
• MalfunctionDec 5, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SACROCOLPOPEXY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE SWAGE PART DURING USE ON THE UTERINE CERVIX. THE NEEDLE FRAGMENT WAS NOT LOST AND WAS RETRIEVED. NO DEVICES WERE LEFT IN THE PATIENT¿S BODY. THE OPERATION TIME WAS EXTENDED BY 60 MINUTES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8133137 ↗

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.