Coated VICRYL J339HRecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10705031039018), received between Jul 9, 2018 and Aug 25, 2025 — classified as 1 death, 22 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Material Separation” (14 reports).

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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE KEEPS POOPING OFF AND THE SUTURE HAD A MINIMAL FORCE. THERE WERE NO PATIENT ADVERSE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22887622 ↗
• MalfunctionAug 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. THE NEEDLE KEEPS POOPING OFF AND THE SUTURE HAD A MINIMAL FORCE. THERE WERE NO PATIENT ADVERSE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22887580 ↗
• MalfunctionSep 19, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, A HOLE THE SIZE OF A NEEDLE WAS FOUND ON THE BACK OF THE PACKAGING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20262727 ↗
• MalfunctionFeb 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE THREAD BROKE WHEN APPLYING THE SURGICAL STITCH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18659255 ↗
• MalfunctionJan 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPIC OB-GYN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. IT WAS NOT 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 18477461 ↗
• MalfunctionDec 28, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. DURING THE SURGICAL PROCEDURE, THE SUTURE BROKE, RESULTING IN A BRITTLE APPEARANCE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18416446 ↗
• MalfunctionJun 30, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, AT THE MOMENT THAT THE DOCTOR BEGINS TO SUTURE WITH THE VICRYL, IT COMES OFF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240818 ↗
• MalfunctionMar 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 02/24/2023 AND SUTURE WAS USED. WHEN THE DOCTOR BEGAN TO SUTURE, THE THREAD DETACHED OF THE NEEDLE, SO THE DOCTOR COULD NO LONGER CONTINUE WITH THE SAME SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16601978 ↗
• MalfunctionMar 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF BEFORE THE KNOT WAS TIED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587797 ↗
• InjuryApr 19, 2022Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY (LM) ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING UTERINE AFTER ENUCLEATIC MYOMECTOMY, THE NEEDLE WAS ADJUSTED SEVERAL TIMES AND WAS DECIDED WHERE TO PASS. WHEN THE NEEDLE WAS HANDLED, THE NEEDLE WAS BROKEN AND THE BROKEN NEEDLE REMAINED IN THE UTERUS, SO THE SURGERY WAS CHANGED TO LAPAROTOMY. THE SMALL INCISION OF LAP WAS CHANGED TO LAPAROTOMY, AND THE WOUND BECAME LONGER. CURRENTLY THERE IS NO PROBLEM WITH THE PATIENT'S PROGRESS. THE PATIENT HAS BEEN DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14141478 ↗
• MalfunctionJan 11, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON (B)(6), 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13225475 ↗
• MalfunctionSep 29, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548811 ↗
• MalfunctionSep 7, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12433539 ↗
• MalfunctionApr 27, 2021Delivered as Unsterile Product; Product Quality Problem; Delivered as Unsterile Product; Product Quality Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, BEFORE BEING USED ON THE PATIENT, THE NEEDLE IN THE SOT PACKAGE WAS FOUND TO BE INSERTED IN THE OPPOSITE DIRECTION, AND ALTHOUGH THE SWAGE PART SIDE WAS USUALLY EXPOSED, THE NEEDLE TIP SIDE WAS EXPOSED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11735359 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PEDIATRIC PATIENT UNDERWENT AN OPEN HEART SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR STERNAL CLOSURE. ONE MONTH AFTER THE SURGERY, POSTOPERATIVE INFECTION OCCURRED AND MSAA WAS DETECTED, THUS, IT WAS SUPPOSED TO BE THE SOURCE OF THE INFECTION. REDDENING ALSO OCCURRED, BUT IT SUBSIDED AFTER REMOVING THE SUTURE. THE AFFECTED WOUND WAS CLEANED. IT WAS REPORTED THAT THE SURGEON OPINED THAT THE SUTURE HAD BEEN CONTAMINATED AND ¿THE POSSIBILITY OF THE SUTURE CAUSING THE SYMPTOM CANNOT BE DENIED.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 11178314 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PEDIATRIC PATIENT UNDERWENT AN OPEN HEART SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR STERNAL CLOSURE. ONE MONTH AFTER THE SURGERY, POSTOPERATIVE INFECTION OCCURRED AND MSAA WAS DETECTED, THUS, IT WAS SUPPOSED TO BE THE SOURCE OF THE INFECTION. REDDENING ALSO OCCURRED, BUT IT SUBSIDED AFTER REMOVING THE SUTURE. THE AFFECTED WOUND WAS CLEANED. IT WAS REPORTED THAT THE SURGEON OPINED THAT THE SUTURE HAD BEEN CONTAMINATED AND THE POSSIBILITY OF THE SUTURE CAUSING THE SYMPTOM CANNOT BE DENIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 11178302 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PEDIATRIC PATIENT UNDERWENT AN OPEN HEART SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR STERNAL CLOSURE. ONE MONTH AFTER THE SURGERY, POSTOPERATIVE INFECTION OCCURRED AND MSAA WAS DETECTED, THUS, IT WAS SUPPOSED TO BE THE SOURCE OF THE INFECTION. REDDENING ALSO OCCURRED, BUT IT SUBSIDED AFTER REMOVING THE SUTURE. THE AFFECTED WOUND WAS CLEANED. IT WAS REPORTED THAT THE SURGEON OPINED THAT THE SUTURE HAD BEEN CONTAMINATED AND THE POSSIBILITY OF THE SUTURE CAUSING THE SYMPTOM CANNOT BE DENIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 11178178 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PEDIATRIC PATIENT UNDERWENT AN OPEN HEART SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR STERNAL CLOSURE. ONE MONTH AFTER THE SURGERY, POSTOPERATIVE INFECTION OCCURRED AND MSAA WAS DETECTED, THUS, IT WAS SUPPOSED TO BE THE SOURCE OF THE INFECTION. REDDENING ALSO OCCURRED, BUT IT SUBSIDED AFTER REMOVING THE SUTURE. THE AFFECTED WOUND WAS CLEANED. IT WAS REPORTED THAT THE SURGEON OPINED THAT THE SUTURE HAD BEEN CONTAMINATED AND ¿THE POSSIBILITY OF THE SUTURE CAUSING THE SYMPTOM CANNOT BE DENIED.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 11178168 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PEDIATRIC PATIENT UNDERWENT AN OPEN HEART SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR STERNAL CLOSURE. ONE MONTH AFTER THE SURGERY, POSTOPERATIVE INFECTION OCCURRED AND MSAA WAS DETECTED, THUS, IT WAS SUPPOSED TO BE THE SOURCE OF THE INFECTION. REDDENING ALSO OCCURRED, BUT IT SUBSIDED AFTER REMOVING THE SUTURE. THE AFFECTED WOUND WAS CLEANED. IT WAS REPORTED THAT THE SURGEON OPINED THAT THE SUTURE HAD BEEN CONTAMINATED AND ¿THE POSSIBILITY OF THE SUTURE CAUSING THE SYMPTOM CANNOT BE DENIED.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 11178143 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PEDIATRIC PATIENT UNDERWENT AN OPEN HEART SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR STERNAL CLOSURE. ONE MONTH AFTER THE SURGERY, POSTOPERATIVE INFECTION OCCURRED AND MSAA WAS DETECTED, THUS, IT WAS SUPPOSED TO BE THE SOURCE OF THE INFECTION. REDDENING ALSO OCCURRED, BUT IT SUBSIDED AFTER REMOVING THE SUTURE. THE AFFECTED WOUND WAS CLEANED. IT WAS REPORTED THAT THE SURGEON OPINED THAT THE SUTURE HAD BEEN CONTAMINATED AND ¿THE POSSIBILITY OF THE SUTURE CAUSING THE SYMPTOM CANNOT BE DENIED.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 11178098 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PEDIATRIC PATIENT UNDERWENT AN OPEN HEART SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR STERNAL CLOSURE. ONE MONTH AFTER THE SURGERY, POSTOPERATIVE INFECTION OCCURRED AND MSAA WAS DETECTED, THUS, IT WAS SUPPOSED TO BE THE SOURCE OF THE INFECTION. REDDENING ALSO OCCURRED, BUT IT SUBSIDED AFTER REMOVING THE SUTURE. THE AFFECTED WOUND WAS CLEANED. IT WAS REPORTED THAT THE SURGEON OPINED THAT THE SUTURE HAD BEEN CONTAMINATED AND ¿THE POSSIBILITY OF THE SUTURE CAUSING THE SYMPTOM CANNOT BE DENIED.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 11178059 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PEDIATRIC PATIENT UNDERWENT AN OPEN HEART SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR STERNAL CLOSURE. ONE MONTH AFTER THE SURGERY, POSTOPERATIVE INFECTION OCCURRED AND MSAA WAS DETECTED, THUS, IT WAS SUPPOSED TO BE THE SOURCE OF THE INFECTION. REDDENING ALSO OCCURRED, BUT IT SUBSIDED AFTER REMOVING THE SUTURE. THE AFFECTED WOUND WAS CLEANED. IT WAS REPORTED THAT THE SURGEON OPINED THAT THE SUTURE HAD BEEN CONTAMINATED AND THE POSSIBILITY OF THE SUTURE CAUSING THE SYMPTOM CANNOT BE DENIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 11178054 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PEDIATRIC PATIENT UNDERWENT AN OPEN HEART SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR STERNAL CLOSURE. ONE MONTH AFTER THE SURGERY, POSTOPERATIVE INFECTION OCCURRED AND MSAA WAS DETECTED, THUS, IT WAS SUPPOSED TO BE THE SOURCE OF THE INFECTION. REDDENING ALSO OCCURRED, BUT IT SUBSIDED AFTER REMOVING THE SUTURE. THE AFFECTED WOUND WAS CLEANED. IT WAS REPORTED THAT THE SURGEON OPINED THAT THE SUTURE HAD BEEN CONTAMINATED AND ¿THE POSSIBILITY OF THE SUTURE CAUSING THE SYMPTOM CANNOT BE DENIED.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 11178030 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PEDIATRIC PATIENT UNDERWENT AN OPEN HEART SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR STERNAL CLOSURE. ONE MONTH AFTER THE SURGERY, POSTOPERATIVE INFECTION OCCURRED AND (B)(6) WAS DETECTED, THUS, IT WAS SUPPOSED TO BE THE SOURCE OF THE INFECTION. IT WAS REPORTED THAT THE INFECTION CAUSED WOUND DEHISCENCE. THEN, THE SUTURE WAS REMOVED, AND THE AFFECTED WOUND WAS CLEANED. IT WAS REPORTED THAT THE SURGEON OPINED THAT THE SUTURE HAD BEEN CONTAMINATED AND ¿THE POSSIBILITY OF THE SUTURE CAUSING THE SYMPTOM CANNOT BE DENIED.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 11177299 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PEDIATRIC PATIENT UNDERWENT AN OPEN HEART SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR STERNAL CLOSURE. ONE MONTH AFTER THE SURGERY, POSTOPERATIVE INFECTION OCCURRED AND (B)(6) WAS DETECTED, THUS, IT WAS SUPPOSED TO BE THE SOURCE OF THE INFECTION. IT WAS REPORTED THAT THE INFECTION CAUSED WOUND DEHISCENCE. THEN, THE SUTURE WAS REMOVED, AND THE AFFECTED WOUND WAS CLEANED. IT WAS REPORTED THAT THE SURGEON OPINED THAT THE SUTURE HAD BEEN CONTAMINATED AND ¿THE POSSIBILITY OF THE SUTURE CAUSING THE SYMPTOM CANNOT BE DENIED.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 11177291 ↗