Coated VICRYL J493GRecalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10705031040496), received between Apr 10, 2019 and Dec 12, 2024 — classified as 6 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Material Separation” (37 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY THE THREE SUTURES IN A ROW WERE EASY TO BREAK. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20921257 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY THE THREE SUTURES IN A ROW WERE EASY TO BREAK. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920830 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY THE THREE SUTURES IN A ROW WERE EASY TO BREAK. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920052 ↗
• MalfunctionDec 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE IS EASY TO LOOSEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855256 ↗
• MalfunctionMar 29, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. THE HEALTHCARE PROFESSIONAL REPORTED THAT THEY HAVE BEEN EXPERIENCING ISSUES WITH THE 5-0 VICRYL SUTURES, 4-0 VICRYL SUTURES, AND 5-0 NYLON. THE 5-0 AND 4-0 VICRYL SUTURES ARE RIPPING IN THE MIDDLE OF THE SUTURE AND THE NEEDLES ARE FALLING OFF. THE 5-0 NYLON NEEDLES ARE COMING IN IRREGULAR SIZES. THERE WAS NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19007553 ↗
• MalfunctionOct 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT SUTURE SEPARATION FROM THE NEEDLE FROM THE THREAD. IT HAPPENS WHEN THE NEEDLE IS GOING THROUGH THE HUB. IT HAS HAPPENED ABOUT 3 OR 4 TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004254 ↗
• MalfunctionOct 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT SUTURE SEPARATION FROM THE NEEDLE FROM THE THREAD. IT HAPPENS WHEN THE NEEDLE IS GOING THROUGH THE HUB. IT HAS HAPPENED ABOUT 3 OR 4 TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004252 ↗
• MalfunctionOct 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT SUTURE SEPARATION FROM THE NEEDLE FROM THE THREAD. IT HAPPENS WHEN THE NEEDLE IS GOING THROUGH THE HUB. IT HAS HAPPENED ABOUT 3 OR 4 TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004250 ↗
• MalfunctionOct 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT SUTURE SEPARATION FROM THE NEEDLE FROM THE THREAD. IT HAPPENS WHEN THE NEEDLE IS GOING THROUGH THE HUB. IT HAS HAPPENED ABOUT 3 OR 4 TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004243 ↗
• MalfunctionOct 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS POPPING OFF THE SUTURE. THE SURGEON STATED IT¿S BEEN HAPPENING FOR MONTHS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878073 ↗
• MalfunctionOct 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS POPPING OFF THE SUTURE. THE SURGEON STATED IT¿S BEEN HAPPENING FOR MONTHS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17877915 ↗
• InjuryAug 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LACERATION CLOSURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, AT A WALK-IN CLINIC, WHILE ATTEMPTING TO SUTURE, THE THREAD BROKE FROM THE NEEDLE. THE NEEDLE WAS NOT FOUND. THE PATIENT WAS TRANSFERRED TO A HOSPITAL FOR X-RAY. A SUTURE NEEDLE WAS LOCATED WITH X-RAY ASSISTANCE AND INSTRUMENTATION PROBING, IT WAS REMOVED IN TOTAL AND DISCARDED IN THE SHARPS BIN, NO JOINT VIOLATION. A DIFFERENT DEEP SUTURE WAS PLACED TO APPROXIMATE THE SUBCUTANEOUS TISSUE AND THEN HORIZONTAL MATTRESSES PLACED TO CLOSE THE SKIN LAYER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17509127 ↗
• MalfunctionApr 28, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING USE, THE SURGEON WAS USING IT AROUND THE BELLY BUTTON AND OPENED A AND NEEDLE POPPED OFF HE TIED IT, HE USED A DIFFERENT SUTURE AND COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES. TEN UNUSED SUTURES ARE AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16829263 ↗
• MalfunctionApr 26, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING USE, THE SURGEON WAS USING IT AROUND THE BELLY BUTTON AND OPENED A SECOND SUTURE AND THE SAME THING HAPPEN.. A DIFFERENT SUTURE WAS USED AND COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16817044 ↗
• MalfunctionMar 14, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT. THE SUTURES RIPPED APART WHILE BEING USED ON A PATIENT. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542651 ↗
• MalfunctionMar 14, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT. THE SUTURES RIPPED APART WHILE BEING USED ON A PATIENT. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542649 ↗
• MalfunctionAug 5, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE BROKE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15175138 ↗
• MalfunctionJun 30, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING THE UNKNOWN PROCEDURE, THE DOCTOR WAS SUTURING THE PATIENT WHEN THE NEEDLE BROKE IN PATIENTS SKIN WHILE HOLDING ONTO THE NEEDLE DRIVER. THE DOCTOR MANAGED TO GET THE NEEDLE OUT BUT HAD TO CUT INTO THE PATIENTS SKIN DEEPER. THEY GOT A NEW SUTURE OF SAME TYPE. THE REPLACEMENT NEEDLE ALMOST BROKE OFF AS WELL BUT THE DOCTOR MANAGED TO STOP TO PREVENT NEEDLE FROM MOVING INTO FAT TISSUE DEEPER. THE PATIENT WAS INFORMED AND UNDERSTOOD NOT TO MOVE. THE REPORT APPEARED TO BE A PROCEDURE WHERE THE PATIENT WAS AWAKE USING LOCAL ANESTHETIC. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation

  MAUDE report 14877282 ↗
• MalfunctionJun 30, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING THE UNKNOWN PROCEDURE, THE DOCTOR WAS SUTURING THE PATIENT WHEN THE NEEDLE BROKE IN PATIENTS SKIN WHILE HOLDING ONTO THE NEEDLE DRIVER. THE DOCTOR MANAGED TO GET THE NEEDLE OUT BUT HAD TO CUT INTO THE PATIENTS SKIN DEEPER. THEY GOT A NEW SUTURE OF SAME TYPE. THE REPLACEMENT NEEDLE ALMOST BROKE OFF AS WELL BUT THE DOCTOR MANAGED TO STOP TO PREVENT NEEDLE FROM MOVING INTO FAT TISSUE DEEPER. THE PATIENT WAS INFORMED AND UNDERSTOOD NOT TO MOVE. THE REPORT APPEARED TO BE A PROCEDURE WHERE THE PATIENT WAS AWAKE USING LOCAL ANESTHETIC. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation

  MAUDE report 14877122 ↗
• MalfunctionMay 6, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE IS POPPING OFF THE SUTURE PREMATURELY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14296716 ↗
• MalfunctionApr 26, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MOHS PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE UNRAVELED. THE PROCEDURE WAS COMPLETED BY DROPPING A DIFFERENT SET OF SUTURES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14210819 ↗
• MalfunctionApr 26, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MOHS PROCEDURE IN (B)(6) AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE UNRAVELED. THE PROCEDURE WAS COMPLETED BY DROPPING A DIFFERENT SET OF SUTURES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14210816 ↗
• MalfunctionApr 26, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MOHS PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE UNRAVELED. THE PROCEDURE WAS COMPLETED BY DROPPING A DIFFERENT SET OF SUTURES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14210812 ↗
• MalfunctionApr 26, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MOHS PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE UNRAVELED. THE PROCEDURE WAS COMPLETED BY DROPPING A DIFFERENT SET OF SUTURES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14210615 ↗
• MalfunctionApr 26, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MOHS PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE UNRAVELED. THE PROCEDURE WAS COMPLETED BY DROPPING A DIFFERENT SET OF SUTURES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14210612 ↗

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