Coated VICRYL J376HRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031039438), received between Jul 18, 2019 and Feb 12, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

6 other recalls cover devices cleared under the same FDA submission (K022269, K183183); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE CUSTOMER THAT THE SUTURE BROKE IN HALF AS DOCTOR WAS PLACING SUTURE IN INCISION TO SUTURE IT. NEEDLE PART WAS FOUND EMBEDDED IN TISSUE AND OTHER HALF IN NEEDLE DRIVER. NO OTHER DETAILS PROVIDED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322561 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE CUSTOMER HAD AN INCIDENT OF A BROKEN SUTURE IN A PATIENT. UNFORTUNATELY THE STAFF DIDN'T SAVE THE PACKING OR BROKEN PIECE ITSELF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22982933 ↗
• MalfunctionApr 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE WHILE LOADING ONTO NEEDLE DRIVER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14119102 ↗
• MalfunctionAug 3, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PASSING THE NEEDLE THROUGH THE FASCIA, THE NEEDLE WAS BROKEN IMMEDIATELY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12270493 ↗
• MalfunctionApr 9, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, DURING WOUND CLOSURE, AFTER THE NEEDLE WAS PASSED THROUGH THE FASCIA, WHEN A SURGEON TRIED TO PUT THE 2ND STITCH, SURGEON NOTICED THAT THE NEEDLE TIP WAS BROKEN. THE BROKEN NEEDLE TIP WAS SEARCHED FOR ABOUT 10 MINUTES. THE NEEDLE TIP WAS CONFIRMED TO BE CAUGHT ON THE PERITONEUM AND REMOVED. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11641951 ↗
• MalfunctionApr 28, 2020Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE INTO TWO PIECES WHILE PASSING THROUGH TISSUE, UNKNOWN LAYER OF TISSUE, UNKNOWN LOOP. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT, FOUND VISUALLY, NO X-RAY WAS NEEDED. A SECOND LIKE NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10006285 ↗
• MalfunctionApr 6, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. WHILE CLOSING THE FASCIA, ¿SNAP" WAS HEARD AND WHEN PULLING THE SUTURE OUT, ONLY HALF OF THE NEEDLE WAS STILL ATTACHED. SINCE UNABLE TO VISUALIZE THE BROKEN NEEDLE WITHIN THE INCISION, FLUOROSCOPY WAS PERFORMED, AND THE IDENTIFIED NEEDLE WAS REMOVED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9931814 ↗
• MalfunctionApr 1, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE INTO TWO PIECES WHILE PASSING THROUGH TISSUE, UNKNOWN LAYER OF TISSUE, UNKNOWN LOOP. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT, FOUND VISUALLY, NO X-RAY WAS NEEDED. A SECOND LIKE NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9914328 ↗
• MalfunctionJul 18, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS BROKEN AT THE BODY PART DURING FASCIA CLOSURE BY INTERRUPTED SUTURING. THE BROKEN NEEDLE WAS DROPPED IN THE ABDOMINAL CAVITY. THE WOUND WAS RE-OPENED, AND THE BROKEN NEEDLE WAS RETRIEVED, THEN THE WOUND WAS RE-CLOSED. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADDITIONAL TREATMENT IS PLANNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8805787 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269, K183183. One submission often covers many models, so check the product and lot details in each record.

• Z-1513-2025 · Mar 7, 2025 · Open, Classified
  PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
• Z-0319-2025 · Sep 25, 2024 · Open, Classified
  Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
• Z-2146-2024 · May 10, 2024 · Open, Classified
  PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery.
• 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