Coated VICRYL D6819Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031026834), received between May 3, 2019 and Nov 20, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 16, 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.

• MalfunctionNov 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING ORTHOPEDIC PROCEDURE, THE NEEDLE WAS PREMATURELY POPPING OFF THE SUTURE. IT HAPPENED FIVE TO SIX TIMES OVER THE LAST TWO MONTHS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICES ARE NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607416 ↗
• MalfunctionNov 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING ORTHOPEDIC PROCEDURE, THE NEEDLE WAS PREMATURELY POPPING OFF THE SUTURE. IT HAPPENED FIVE TO SIX TIMES OVER THE LAST TWO MONTHS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICES ARE NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607414 ↗
• MalfunctionNov 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING ORTHOPEDIC PROCEDURE, THE NEEDLE WAS PREMATURELY POPPING OFF THE SUTURE. IT HAPPENED FIVE TO SIX TIMES OVER THE LAST TWO MONTHS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607203 ↗
• MalfunctionNov 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING ORTHOPEDIC PROCEDURE, THE NEEDLE WAS PREMATURELY POPPING OFF THE SUTURE. IT HAPPENED FIVE TO SIX TIMES OVER THE LAST TWO MONTHS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICES ARE NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606737 ↗
• MalfunctionNov 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING ORTHOPEDIC PROCEDURE, THE NEEDLE WAS PREMATURELY POPPING OFF THE SUTURE. IT HAPPENED FIVE TO SIX TIMES OVER THE LAST TWO MONTHS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICES ARE NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606697 ↗
• MalfunctionNov 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING ORTHOPEDIC PROCEDURE, THE NEEDLE WAS PREMATURELY POPPING OFF THE SUTURE. IT HAPPENED FIVE TO SIX TIMES OVER THE LAST TWO MONTHS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICES ARE NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606670 ↗
• MalfunctionFeb 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE NEEDLE KEPT POPPING OFF THE SUTURES. THE SURGERY, DATE OF SURGERY AND EVENT OCCURRENCE ARE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369304 ↗
• MalfunctionMay 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PREMATURELY POPPED OFF WHILE SUTURING. THIS OCCURRED AFTER SEVERAL PASSES. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579495 ↗
• MalfunctionMay 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PREMATURELY POPPED OFF WHILE SUTURING. THIS OCCURRED AFTER SEVERAL PASSES. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579494 ↗
• MalfunctionMay 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PREMATURELY POPPED OFF WHILE SUTURING. THIS OCCURRED AFTER SEVERAL PASSES. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579492 ↗
• MalfunctionMay 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL KNEE REPLACEMENT ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE PREMATURELY POPPED OFF WHILE SUTURING. THIS OCCURRED AFTER SEVERAL PASSES. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579491 ↗

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