Coated VICRYL J214HRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705031038226), received between Jul 24, 2018 and Sep 30, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949539 ↗
• MalfunctionMay 16, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM, #MW 4100070000-2025-8039, DURING AN UNKNOWN PROCEDURE THE ETHICON 4-0 VICRYL RB-1 SUTURE WAS SUPPOSED TO BE SINGLE ARMED WITH ONE NEEDLE, BUT IT HAD 2 NEEDLES. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035885 ↗
• MalfunctionApr 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO SALES REP BY STAFF THE NEEDLE CAME OFF THE SUTURE. NO PATIENT HARM WAS REPORTED. SURGICAL DELAY UNKNOWN. ONE DEVICE RETURNING. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910768 ↗
• MalfunctionSep 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, BOTH SUTURES DURING SURGERY THE NEEDLE WAS POPPING OFF. THE NEEDLE AND SUTURE WAS DISCARDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787971 ↗
• MalfunctionNov 4, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. ALTHOUGH IT SHOULD BE A PURPLE SUTURE, IT WAS FOUND THAT THERE WAS A WHITE SUTURE IN THE PACKAGE WHEN OPENING THE PACKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15734794 ↗
• MalfunctionNov 4, 2022Break; Break

  PER USER FACILITY MEDWATCH FORM, MWIT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM, MW5112157, THE NEEDLE BROKE WHILE PERFORMING SUTURING DURING OPERATIVE CASE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15726703 ↗
• MalfunctionMar 30, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC CYSTECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHILE SUTURING, THE SUTURE FRAYED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593522 ↗
• MalfunctionMar 30, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC CYSTECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHILE SUTURING, THE SUTURE FRAYED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593521 ↗
• MalfunctionMar 30, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC CYSTECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHILE SUTURING, THE SUTURE FRAYED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593519 ↗
• MalfunctionMar 30, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC CYSTECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHILE SUTURING, THE SUTURE FRAYED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593518 ↗
• MalfunctionFeb 8, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE IS FRAYING DURING USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11297028 ↗
• MalfunctionDec 9, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10977546 ↗
• MalfunctionNov 25, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE IN 2020 AND SUTURE WAS USED. THE SUTURE WAS FRAYING VERY BADLY AFTER IT PASSED THROUGH THE TISSUE. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. IT IS UNKNOWN IF THERE WERE ANY PATIENT COMPLICATIONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10902005 ↗
• MalfunctionNov 25, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE IN 2020 AND SUTURE WAS USED. THE SUTURE WAS FRAYING VERY BADLY AFTER IT PASSED THROUGH THE TISSUE. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. IT IS UNKNOWN IF THERE WERE ANY PATIENT COMPLICATIONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10901967 ↗
• MalfunctionMar 6, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9799576 ↗
• MalfunctionMar 6, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9799570 ↗
• MalfunctionMar 6, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9799563 ↗
• MalfunctionMar 6, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9799561 ↗
• MalfunctionMar 6, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9799557 ↗
• MalfunctionMar 6, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9799556 ↗
• MalfunctionMar 6, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9799553 ↗
• MalfunctionMar 6, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9799542 ↗
• MalfunctionJul 1, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE IN HALF. X-RAY WAS AND WOUND EXPLORATION WERE USED TO SEARCH OUT AND FIND THE PIECES. ALL PIECES WERE ACCOUNTED FOR. THE PROCEDURE WAS COMPLETED AT THAT TIME AND NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8748433 ↗
• MalfunctionJul 1, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST LUMPECTOMY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED EASILY. THE PROCEDURE WAS COMPLETED WITH A ALTERNATE LIKE DEVICE WITH NO ADVERSE PATIENT CONSEQUENCES REPORTED. THERE IS NO ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8748297 ↗
• MalfunctionJun 11, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2019 AND SUTURE WAS USED. THE NEEDLE WAS BROKEN AT THE TIP DURING USE. NO BROKEN PIECES WERE DROPPED IN THE PATIENT BODY. THERE WERE NO PATIENT CONSEQUENCES WERE REPORTED. THERE IS NO FURTHER INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689899 ↗

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