Coated VICRYL JB724Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10705031043954), received between Jun 28, 2019 and Jan 31, 2025 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Material Separation” (21 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE WHEN THE NEEDLE WAS GRASPED WITH A NEEDLE HOLDER AND THE SUTURE WAS PULLED OUT. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED. UPON EVALUATION OF THE RETURNED DEVICE, THE INSERTION END DID NOT MEET THE REQUIREMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21286918 ↗
• MalfunctionJan 31, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE WHEN THE NEEDLE WAS GRASPED WITH A NEEDLE HOLDER AND THE SUTURE WAS PULLED OUT. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED. UPON EVALUATION OF THE RETURNED DEVICE, THE INSERTION END DID NOT MEET THE REQUIREMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21286917 ↗
• MalfunctionDec 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT, IN THE PACKAGE, ONE NEEDLE OUT OF 8 HAD BEEN DETACHED FROM THE SUTURE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. BASED ON THE INFORMATION CURRENTLY AVAILABLE, SHORT INSERTION ISSUE WAS IDENTIFIED AS PULL OUT DURING THE INVESTIGATION OF THE SAMPLE RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914885 ↗
• MalfunctionOct 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING FASCIAL INTERRUPTED SUTURE. THIS HAPPENED IN 3 PACKAGES IN A ROW. OTHER PRODUCT FROM A DIFFERENT BOX WAS USED AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913304 ↗
• MalfunctionOct 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING FASCIAL INTERRUPTED SUTURE. THIS HAPPENED IN 3 PACKAGES IN A ROW. OTHER PRODUCT FROM A DIFFERENT BOX WAS USED AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913300 ↗
• MalfunctionOct 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING FASCIAL INTERRUPTED SUTURE. THIS HAPPENED IN 3 PACKAGES IN A ROW. OTHER PRODUCT FROM A DIFFERENT BOX WAS USED AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913295 ↗
• MalfunctionDec 23, 2020Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11066451 ↗
• MalfunctionNov 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9378262 ↗
• MalfunctionJul 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING INTERRUPTED SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8751496 ↗
• MalfunctionJul 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING INTERRUPTED SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8751495 ↗
• MalfunctionJul 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2019 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING USE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8749859 ↗
• MalfunctionJul 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2019 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING USE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8749807 ↗
• MalfunctionJul 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2019 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING USE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8749791 ↗
• MalfunctionJul 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2019, AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING USE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8749772 ↗
• MalfunctionJul 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2019 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING USE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8749660 ↗
• MalfunctionJun 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING INTERRUPTED SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746353 ↗
• MalfunctionJun 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING INTERRUPTED SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746340 ↗
• MalfunctionJun 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING INTERRUPTED SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746326 ↗
• MalfunctionJun 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING INTERRUPTED SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746309 ↗
• MalfunctionJun 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING INTERRUPTED SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746284 ↗
• MalfunctionJun 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING INTERRUPTED SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746272 ↗
• MalfunctionJun 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING INTERRUPTED SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746267 ↗
• MalfunctionJun 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING INTERRUPTED SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746259 ↗
• MalfunctionJun 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING INTERRUPTED SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746249 ↗
• MalfunctionJun 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING INTERRUPTED SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746171 ↗

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