Coated VICRYL J603HRecalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 10705031041639), received between May 3, 2019 and Apr 1, 2026 — classified as 1 injury, 79 malfunctions.

The most frequently reported specific device problem is “Material Separation” (41 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 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756652 ↗
• MalfunctionFeb 23, 2026Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT SEMI-OPEN TRANS-ABDOMINAL PRE-PERITONEAL REPAIR ON (B)(6) 2026, AND SUTURE WAS USED. WHILE CLOSING THE WOUND, AFTER PLACING ONE STITCH AND PULLING, THE SUTURE DETACHED FROM THE NEEDLE. IT WAS NOT 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 24421705 ↗
• MalfunctionJan 28, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE. THIS ISSUE OCCURRED 2 PRODUCTS IN A ROW. THERE WAS NO PROBLEM WITH THE THIRD ONE. IT WAS NOT 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 24201176 ↗
• MalfunctionJan 28, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOW PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE. THIS ISSUE OCCURRED 2 PRODUCTS IN A ROW. THERE WAS NO PROBLEM WITH THE THIRD ONE. IT WAS NOT 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 24201168 ↗
• MalfunctionDec 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHILE SUTURING, THE NEEDLE AND SUTURE WAS DETACHED. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693476 ↗
• MalfunctionFeb 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469752 ↗
• MalfunctionJan 17, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2024 AND SUTURE WAS USED. WHEN A SCRUB NURSE TRIED TO GRASP THE NEEDLE WITH THE NEEDLE HOLDER, A SCRUB NURSE NOTICED THAT THERE WAS A FOREIGN MATTER LIKE A HAIR IN THE WHITE TRAY OF THE SUTURE AND USE WAS STOPPED. THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178856 ↗
• MalfunctionAug 21, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC EXCISION OF ENDOMETRIOSIS AND CHROMOTUBATION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHILE THE SURGEON WAS SUTURING THE PATIENT'S LAPAROSCOPIC TROCAR SITE CLOSED, THE ATRAUMATIC SUTURE NEEDLE BROKE INTO TWO DISTINCT PARTS. SUTURE END WAS USED AT BEGINNING OF CASE PRIOR TO THIS INCIDENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20009227 ↗
• InjuryJul 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE MALFUNCTIONED AND THE NEEDLE WAS RETAINED IN THE BODY AND PATIENT WAS RETURNED TO THE OR FOR REMOVAL. THE SUTURE POPPED OFF THE NEEDLE INSIDE THE PATIENT WHEN PASSING THROUGH. THEY WERE ABLE TO OBTAIN THE NEEDLE AND COMPLETE THE REST OF THE CASE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19834476 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPROSCOPIC GYN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHEN TRYING TO REMOVE SUTURE FROM THE TROCAR. THE SURGEON WAS ABLE TO RETRIEVE ALL THE PIECES AND COMPLETE THE REMAINDER OF THE CASE WITHOUT PATIENT HARM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19714775 ↗
• MalfunctionJun 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SURGERY, WHEN CLOSING SURGICAL WOUNDS, THE SURGEON MANIPULATES THE SUTURE AND THIS COMES OFF FROM THE SURGICAL NEEDLE/THREAD JUNCTION, WHICH IS WHY ANOTHER SUTURE WITH THE SAME CHARACTERISTICS IS REQUESTED AND THIS IS CUT FROM ITS THREAD. IT IS POSSIBLE TO SEE THE SUTURES ARE FROM THE SAME LOT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19502802 ↗
• MalfunctionJun 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SURGERY, WHEN CLOSING SURGICAL WOUNDS, THE SURGEON MANIPULATES THE SUTURE AND THIS COMES OFF FROM THE SURGICAL NEEDLE/THREAD JUNCTION, WHICH IS WHY ANOTHER SUTURE WITH THE SAME CHARACTERISTICS IS REQUESTED AND THIS IS CUT FROM ITS THREAD. IT IS POSSIBLE TO SEE THE SUTURES ARE FROM THE SAME LOT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19502712 ↗
• MalfunctionMay 14, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A LAP LIVER RESECTION AND LAP COLECTOMY ON (B)(6) 2024, AND SUTURE WAS USED. NEEDLE ON J603 SUTURE (UR-6) BROKE AT PROXIMAL 1/3 (CLOSEST TO SWAGE) WHEN TRYING TO SUTURE TISSUE AT A TROCAR/PORT SITE. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315205 ↗
• MalfunctionApr 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING USE AND WAS RETRIEVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19156225 ↗
• MalfunctionApr 4, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19046627 ↗
• MalfunctionApr 4, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19046372 ↗
• MalfunctionMar 14, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. THE SUTURE'S STRING WAS BROKEN DURING THE PROCEDURE. THE DOCTOR CHANGED TO A NEW ONE AND CONTINUED THE SURGERY SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18902135 ↗
• MalfunctionFeb 28, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT SHORT INSERTION WAS OBSERVED IN THE STRAND. IT WAS REPORTED THAT WHILE THEY WERE LOADING THE SUTURE, AS SOON AS THEY CLOCKED THE NEEDLE DRIVER SHUT TO START PULLING IT OUT OF THE PACKAGE THE NEEDLE POPPED RIGHT OFF. IT MIGHT BE THE WAY THEY PULLED IT OUT BUT THEY FEEL LIKE THERE WAS NO FORCE WHEN BEING PULLED, IT JUST CAME OFF. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18797861 ↗
• MalfunctionDec 20, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A WOUND CLOSURE ON (B)(6). 2023 AND SUTURE WAS USED. SUTURE DISCONNECTED FROM NEEDLE WHILST BEING HANDED TO THE SURGEON. HAD NOT BEEN USED, WAS A FRESH SUTURE, LITERALLY FELL OFF. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18365269 ↗
• MalfunctionDec 20, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A WOUND CLOSURE ON (B)(6) 2023 AND SUTURE WAS USED. SUTURE DISCONNECTED FROM NEEDLE WHILST BEING HANDED TO THE SURGEON. HAD NOT BEEN USED, WAS A FRESH SUTURE, LITERALLY FELL OFF. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18365243 ↗
• MalfunctionDec 11, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. WHEN THE SURGEON PULLED THE SUTURE LIGHTLY DURING USE, THE SUTURE DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301633 ↗
• MalfunctionDec 11, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. WHEN THE SURGEON PULLED THE SUTURE LIGHTLY DURING USE, THE SUTURE DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301611 ↗
• MalfunctionNov 8, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. IT WAS REPORTED THAT THERE WAS AN INCIDENT INVOLVING A SUTURE AND AN INTERNAL INVESTIGATION HAD BEGUN. DURING THE PROCEDURE, THE NEEDLE BROKE OFF AT THE SWAGE SITE VERY EASILY INSIDE THE PATIENT'S ABDOMINAL WALL. NO ADVERSE PATIENT OUTCOMES REPORTED AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092761 ↗
• MalfunctionSep 8, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE ISSUE OF SUTURE BREAKAGE DURING USE OCCURRED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17713943 ↗
• MalfunctionSep 8, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE ISSUE OF SUTURE BREAKAGE DURING USE OCCURRED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17713378 ↗

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