Coated VICRYL D10045Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031134300), received between Jul 18, 2019 and Aug 22, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (14 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN USED IN THE OPERATION, THE SUTURE HAD BEEN DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043968 ↗
• MalfunctionAug 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN USED IN THE OPERATION, THE SUTURE HAD BEEN DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043955 ↗
• MalfunctionAug 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN USED IN THE OPERATION, THE SUTURE HAD BEEN DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20042708 ↗
• MalfunctionAug 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN USED IN THE OPERATION, THE SUTURE HAD BEEN DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20042452 ↗
• MalfunctionAug 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN USED IN THE OPERATION, THE SUTURE HAD BEEN DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20040162 ↗
• MalfunctionMay 16, 2022Material Separation; Material Separation

  IT WAS REPORTED BY A SALES REP THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING USE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407667 ↗
• MalfunctionOct 22, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ARTIFICIAL JOINT REPLACEMENT ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE WHILE SEWING THE FASCIA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12684874 ↗
• MalfunctionOct 22, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ARTIFICIAL JOINT REPLACEMENT ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE WHILE SEWING THE FASCIA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12684811 ↗
• MalfunctionOct 22, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ARTIFICIAL JOINT REPLACEMENT ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE WHILE SEWING THE FASCIA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12684784 ↗
• MalfunctionMar 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE MORE EASILY THAN USUAL. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9845814 ↗
• MalfunctionMar 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE MORE EASILY THAN USUAL. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9845812 ↗
• MalfunctionNov 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE PULLED OFF FROM THE NEEDLE EASILY DURING CLOSING OF THE SURGICAL WOUND ON THE MUSCLE LAYER BY INTERRUPTED SUTURING. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PACKAGE WITH ANOTHER LOT NUMBER WAS USED WITH NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268408 ↗
• MalfunctionNov 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE PULLED OFF FROM THE NEEDLE EASILY DURING CLOSING OF THE SURGICAL WOUND ON THE MUSCLE LAYER BY INTERRUPTED SUTURING. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PACKAGE WITH ANOTHER LOT NUMBER WAS USED WITH NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268402 ↗
• MalfunctionJul 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE IN 2019 AND SUTURE WAS USED. THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT AVAILABLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8805160 ↗

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