Coated VICRYL D10149Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031225121), received between Jun 10, 2022 and May 21, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (11 reports).

2 other recalls cover devices cleared under the same FDA submission (K032420, K132580, K181652); 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.

• MalfunctionMay 21, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIB FIXATION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY WHEN THE SUTURE WAS APPLIED AND PULLED OUT. THE SURROUNDING FASCIA WAS SUTURED TOGETHER. THE SUTURE WAS DETACHED FROM THE NEEDLE EASIER THAN USUAL. IT WAS A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25247887 ↗
• MalfunctionDec 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OPEN CHEST PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING OPEN CHEST SURGERY, THE NEEDLE DETACHED UNDER SUTURING. THE DOCTOR KNOWS WHAT CONTROL RELEASE IS. THERE IS NO APPLICABLE PRODUCT BECAUSE IT HAS ALREADY BEEN SUTURED AND USED AS IT WAS. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770925 ↗
• MalfunctionSep 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN RESPIRATORY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN RESPIRATORY SURGERY, THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE FROM THE BEGINNING WHEN THE PACKAGE WAS OPENED. THE CUSTOMER REQUESTED TO TAKE A PHOTO AND INVESTIGATE POSSIBLE REASONS WHY THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE FROM THE BEGINNING BECAUSE THERE WAS ONLY THIS PRODUCT. THIS EVENT WAS FOUND BEFORE USE. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095725 ↗
• MalfunctionApr 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THIS UNKNOWN RESPIRATORY SURGERY, THE SUTURE HAD COME OFF EASILY. IT WAS A CONTROL RELEASE NEEDLE. THE SUTURE WAS USED ON INTERCOSTAL MUSCLE, AND THE DOCTOR WAS CAREFUL NOT TO HOLD THE SWAGE PART OF THE NEEDLE, BUT THE SUTURE WAS DETACHED WHEN THE NEEDLE WAS PULLED OUT FROM TISSUE, AND THE SUTURE COULD NOT BE USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133021 ↗
• MalfunctionApr 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THIS UNKNOWN RESPIRATORY SURGERY, THE SUTURE HAD COME OFF EASILY. IT WAS A CONTROL RELEASE NEEDLE. THE SUTURE WAS USED ON INTERCOSTAL MUSCLE, AND THE DOCTOR WAS CAREFUL NOT TO HOLD THE SWAGE PART OF THE NEEDLE, BUT THE SUTURE WAS DETACHED WHEN THE NEEDLE WAS PULLED OUT FROM TISSUE, AND THE SUTURE COULD NOT BE USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132998 ↗
• MalfunctionApr 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THIS UNKNOWN RESPIRATORY SURGERY, THE SUTURE HAD COME OFF EASILY. IT WAS A CONTROL RELEASE NEEDLE. THE SUTURE WAS USED ON INTERCOSTAL MUSCLE, AND THE DOCTOR WAS CAREFUL NOT TO HOLD THE SWAGE PART OF THE NEEDLE, BUT THE SUTURE WAS DETACHED WHEN THE NEEDLE WAS PULLED OUT FROM TISSUE, AND THE SUTURE COULD NOT BE USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132986 ↗
• MalfunctionApr 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THIS UNKNOWN RESPIRATORY SURGERY, THE SUTURE HAD COME OFF EASILY. IT WAS A CONTROL RELEASE NEEDLE. THE SUTURE WAS USED ON INTERCOSTAL MUSCLE, AND THE DOCTOR WAS CAREFUL NOT TO HOLD THE SWAGE PART OF THE NEEDLE, BUT THE SUTURE WAS DETACHED WHEN THE NEEDLE WAS PULLED OUT FROM TISSUE, AND THE SUTURE COULD NOT BE USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132974 ↗
• MalfunctionApr 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THIS UNKNOWN RESPIRATORY SURGERY, THE SUTURE HAD COME OFF EASILY. IT WAS A CONTROL RELEASE NEEDLE. THE SUTURE WAS USED ON INTERCOSTAL MUSCLE, AND THE DOCTOR WAS CAREFUL NOT TO HOLD THE SWAGE PART OF THE NEEDLE, BUT THE SUTURE WAS DETACHED WHEN THE NEEDLE WAS PULLED OUT FROM TISSUE, AND THE SUTURE COULD NOT BE USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132965 ↗
• MalfunctionApr 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THIS UNKNOWN RESPIRATORY SURGERY, THE SUTURE HAD COME OFF EASILY. IT WAS A CONTROL RELEASE NEEDLE. THE SUTURE WAS USED ON INTERCOSTAL MUSCLE, AND THE DOCTOR WAS CAREFUL NOT TO HOLD THE SWAGE PART OF THE NEEDLE, BUT THE SUTURE WAS DETACHED WHEN THE NEEDLE WAS PULLED OUT FROM TISSUE, AND THE SUTURE COULD NOT BE USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132958 ↗
• MalfunctionApr 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THIS UNKNOWN RESPIRATORY SURGERY, THE SUTURE HAD COME OFF EASILY. IT WAS A CONTROL RELEASE NEEDLE. THE SUTURE WAS USED ON INTERCOSTAL MUSCLE, AND THE DOCTOR WAS CAREFUL NOT TO HOLD THE SWAGE PART OF THE NEEDLE, BUT THE SUTURE WAS DETACHED WHEN THE NEEDLE WAS PULLED OUT FROM TISSUE, AND THE SUTURE COULD NOT BE USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132942 ↗
• MalfunctionJun 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN RESPIRATORY SURGERY ON 05/16/2022 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655729 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032420, K132580, K181652. One submission often covers many models, so check the product and lot details in each record.

• Z-2145-2024 · May 10, 2024 · Open, Classified
  VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological
• Z-1310-2009 · Feb 2, 2009 · Terminated
  Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and