Coated VICRYL JB725Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031043961), received between Jun 24, 2019 and Jun 9, 2025 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 reports).

3 other recalls cover devices cleared under the same FDA submission (K022269); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FACTORS AFFECTING GASLESS REDUCED-PORT LAPAROSCOPIC MYOMECTOMY (GRP-LM) USING A SUBCUTANEOUS ABDOMINAL WALL LIFTING METHOD: A RETROSPECTIVE ANALYSIS OF A LARGE COHORT OF 966 CASES IN JAPAN. THE AIM OF THIS STUDY IS TO EVALUATE THE SAFETY, OPERABILITY, AND ECONOMIC EFFICIENCY OF THIS TECHNIQUE, AS WELL AS TO EXAMINE THE FACTORS THAT INFLUENCE THIS TECHNIQUE BASED ON RELEVANT PATIENT BACKGROUNDS AND PATHOGENESIS OF UTERINE FIBROIDS IN GRP-LM CASES. BETWEEN 2005 AND 2016, GASLESS REDUCED-PORT LAPAROSCOPIC MYOMECTOMY (GRP-LM) WAS PERFORMED IN 966 PATIENTS. THE MEDIAN AND RANGE OF AGE AND BODY MASS INDEX (BMI) OF PATIENTS WITH GRP-LM WERE 37 (22¿55) YEARS AND 20.6 (14.5¿32.8) KG/M2, RESPECTIVELY. EIGHTY-NINE PATIENTS (9.2% OF ALL PATIENTS) WERE OBESE WITH A BMI OF 25 OR MORE. OF THESE, 89 PATIENTS (9.2% OF ALL PATIENTS) HAD PREVIOUS SURGERIES. THE SUTURE OF THE MUSCLE LAYER WAS PERFORMED WITH A SINGLE-KNOT SUTURE USING CONTROL RELEASETM SYNTHETIC ABSORBENT THREADS (1-0 AND 3-0) OR LARGE NEEDLES (NEEDLE LENGTH 48MM, SUTURE SIZE 1: VICRYL JB725, ETHICON, US). REPORTED COMPLICATIONS ARE: VICRYL JB725 SUTURES (LARGE NEEDLES, NEEDLE LENGTH 48MM, SUTURE SIZE 1; ETHICON) UNKNOWN EVENT (N=?). T

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22172201 ↗
• MalfunctionSep 24, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, A FOREIGN MATTER WAS FOUND WHEN THE PACKAGE WAS OPENED. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291927 ↗
• MalfunctionJun 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT UNDERWENT A C-SECTION ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE IN ONE OUT OF EIGHT NEEDLES BEFORE USE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498885 ↗
• MalfunctionMay 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OB-GYN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CONTROL RELEASE NEEDLE HAD BEEN DETACHED UNINTENTIONALLY DURING SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19276629 ↗
• MalfunctionMay 14, 2022Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402809 ↗
• MalfunctionMay 14, 2022Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402806 ↗
• MalfunctionMay 13, 2022Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402766 ↗
• MalfunctionApr 21, 2022Material 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 NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING INTERRUPTED SUTURING ON FASCIA. THIS HAPPENED MANY TIMES. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14171735 ↗
• MalfunctionJun 22, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE 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 12041436 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL VAGINAL HYSTERECTOMY IN 2018 AND THE SUTURE WAS USED. AFTER THE SURGERY, THE PATIENT VISITED THE UROLOGY DEPARTMENT OF THE SAME HOSPITAL COMPLAINING OF BLADDER PAIN. CYSTOSCOPY SHOWED THAT THE SUTURE HAD BEEN BITING THE BLADDER, SO IT WAS REMOVED WITH THE CYSTOSCOPY. IT IS UNKNOWN WHAT TYPE OF SUTURE WAS REMOVED. THE PRODUCT CODE NUMBER IS NOT CONFIRMED. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. IT WAS REPORTED THE PATIENT RECOVERED AS OF NOW. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess; Bacterial Infection; Erosion; Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain

  MAUDE report 11467270 ↗
• MalfunctionSep 28, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN EASILY DURING INTERRUPTED SUTURING ON THE FASCIA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10596751 ↗
• MalfunctionAug 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY, SO USE WAS STOPPED. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WITH A DIFFERENT LOT NUMBER WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10400885 ↗
• MalfunctionJun 24, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, BEFORE OPENING THE PACKAGE, IT WAS FOUND THAT THERE HAD BEEN A FOREIGN SUBSTANCE LIKE 2 ¿ 3 CM HAIR IN THE PACKAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8726807 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269. One submission often covers many models, so check the product and lot details in each record.

• Z-2144-2024 · May 10, 2024 · Open, Classified
  VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and
• Z-0989-2020 · Jan 3, 2020 · Terminated
  Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
• Z-1087-06 · May 4, 2006 · Terminated
  Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gyc