Coated VICRYL JB841Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10705031044036), received between May 3, 2018 and Jan 24, 2025 — classified as 1 injury, 43 malfunctions.

The most frequently reported specific device problem is “Material Separation” (23 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BREAKAGE OCCURRED FREQUENTLY DURING USE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229942 ↗
• MalfunctionJan 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BREAKAGE OCCURRED FREQUENTLY DURING USE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229941 ↗
• MalfunctionJan 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BREAKAGE OCCURRED FREQUENTLY DURING USE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229940 ↗
• MalfunctionJan 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BREAKAGE OCCURRED FREQUENTLY DURING USE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229938 ↗
• MalfunctionJan 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BREAKAGE OCCURRED FREQUENTLY DURING USE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229931 ↗
• MalfunctionSep 27, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE EASILY DETACHED FROM THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20317943 ↗
• MalfunctionSep 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC ARTIFICIAL ANUS CREATION PROCEDURE ON 8/30/2024 FIBRIN SEALANT WAS USED. THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE FROM THE CR CASE DURING THE SURGERY. THIS OCCURRED IN FIVE OF THE EIGHT SUTURES IN THE CASE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246317 ↗
• MalfunctionSep 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC ARTIFICIAL ANUS CREATION PROCEDURE ON (B)(6) 2024 FIBRIN SEALANT WAS USED. THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE FROM THE CR CASE DURING THE SURGERY. THIS OCCURRED IN FIVE OF THE EIGHT SUTURES IN THE CASE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246211 ↗
• MalfunctionSep 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC ARTIFICIAL ANUS CREATION PROCEDURE ON (B)(6) 2024 FIBRIN SEALANT WAS USED. THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE FROM THE CR CASE DURING THE SURGERY. THIS OCCURRED IN FIVE OF THE EIGHT SUTURES IN THE CASE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246206 ↗
• MalfunctionSep 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC ARTIFICIAL ANUS CREATION PROCEDURE ON (B)(6) 2024 FIBRIN SEALANT WAS USED. THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE FROM THE CR CASE DURING THE SURGERY. THIS OCCURRED IN FIVE OF THE EIGHT SUTURES IN THE CASE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246164 ↗
• MalfunctionSep 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC ARTIFICIAL ANUS CREATION PROCEDURE ON (B)(6) 2024 FIBRIN SEALANT WAS USED. THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE FROM THE CR CASE DURING THE SURGERY. THIS OCCURRED IN FIVE OF THE EIGHT SUTURES IN THE CASE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246094 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON AN UNKNOWN PROCEDURE AND SUTURE WAS USED. DURING INTERRUPTED SUTURE, FIVE SUTURES HAD BROKEN AT THE SWAGE PART OF THE SUTURE AND NEEDLE IN A ROW. THE REST OF THE PACKAGE WAS NOT USED, AND A NEW PACKAGE WAS OPENED AND USED, AFTER THAT THE OPERATION WENT ON WITHOUT PROBLEM. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458733 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON AN UNKNOWN PROCEDURE AND SUTURE WAS USED. DURING INTERRUPTED SUTURE, FIVE SUTURES HAD BROKEN AT THE SWAGE PART OF THE SUTURE AND NEEDLE IN A ROW. THE REST OF THE PACKAGE WAS NOT USED, AND A NEW PACKAGE WAS OPENED AND USED, AFTER THAT THE OPERATION WENT ON WITHOUT PROBLEM. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458722 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON AN UNKNOWN PROCEDURE AND SUTURE WAS USED. DURING INTERRUPTED SUTURE, FIVE SUTURES HAD BROKEN AT THE SWAGE PART OF THE SUTURE AND NEEDLE IN A ROW. THE REST OF THE PACKAGE WAS NOT USED, AND A NEW PACKAGE WAS OPENED AND USED, AFTER THAT THE OPERATION WENT ON WITHOUT PROBLEM. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458674 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON AN UNKNOWN PROCEDURE AND SUTURE WAS USED. DURING INTERRUPTED SUTURE, FIVE SUTURES HAD BROKEN AT THE SWAGE PART OF THE SUTURE AND NEEDLE IN A ROW. THE REST OF THE PACKAGE WAS NOT USED, AND A NEW PACKAGE WAS OPENED AND USED, AFTER THAT THE OPERATION WENT ON WITHOUT PROBLEM. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458665 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON AN UNKNOWN PROCEDURE AND SUTURE WAS USED. DURING INTERRUPTED SUTURE, FIVE SUTURES HAD BROKEN AT THE SWAGE PART OF THE SUTURE AND NEEDLE IN A ROW. THE REST OF THE PACKAGE WAS NOT USED, AND A NEW PACKAGE WAS OPENED AND USED, AFTER THAT THE OPERATION WENT ON WITHOUT PROBLEM. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458630 ↗
• MalfunctionMar 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE DURING USE. A PRODUCT FROM A DIFFERENT LOT WAS USED. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896737 ↗
• MalfunctionMar 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE IMMEDIATELY. 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 18887187 ↗
• MalfunctionFeb 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING AN UNKNOWN ORTHOPEDIC SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING INTERRUPTED SUTURE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. IT WAS 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 18698753 ↗
• MalfunctionFeb 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FEMORAL NECK FRACTURE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT SHORT INSERTION WAS OBSERVED. DURING A SURGERY FOR FEMORAL NECK FRACTURE, AFTER OPENING THE PACKAGE AND BEFORE USE, IN THE 2ND SLOT ON THE TRAY, THE SUTURE WAS ALREADY DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640569 ↗
• MalfunctionDec 15, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE ON 12-OCT-2023 AND SUTURE WAS USED. DURING AN UNKNOWN UROLOGICAL SURGERY, AFTER OPENING THE PACKAGE, THERE WERE TWO SHEETS OF PRINTED PAPER INSIDE THE PACKAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18335357 ↗
• MalfunctionDec 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. BEFORE TYING THE SUTURE, THE SUTURE DETACHED FROM THE NEEDLE DURING USE. IT WAS A CONTROL RELEASE NEEDLE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18328819 ↗
• MalfunctionDec 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. BEFORE TYING THE SUTURE, THE SUTURE DETACHED FROM THE NEEDLE DURING USE. IT WAS A CONTROL RELEASE NEEDLE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18328813 ↗
• MalfunctionDec 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 17-NOV-2023 AND SUTURE WAS USED. BEFORE TYING THE SUTURE, THE SUTURE DETACHED FROM THE NEEDLE DURING USE. IT WAS A CONTROL RELEASE NEEDLE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18328806 ↗
• MalfunctionDec 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 17-NOV-2023 AND SUTURE WAS USED. BEFORE TYING THE SUTURE, THE SUTURE DETACHED FROM THE NEEDLE DURING USE. IT WAS A CONTROL RELEASE NEEDLE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18328781 ↗

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