Coated VICRYL J340HRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10705031039032), received between Aug 23, 2019 and Aug 25, 2025 — classified as 2 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE MAYBE BECAUSE IT WAS THE THIRD TIME THE PATIENT HAD A C- SECTION MAYBE BECAUSE OF SCARRING OF THE ABDOMINAL WALL. THERE WERE NO PATIENT ADVERSE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22886565 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ROBOTIC PROCEDURE ON 10-APR-2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE CLOSING THE PORT SITE, THE NEEDLE BROKE. X-RAY WAS USED TO FIND THE FRAGMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994553 ↗
• InjuryApr 2, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2025 AND SUTURE WAS USED FOR CLOSURE. TWELVE HOURS POST-OP, THE SUTURE BROKE. THE PATIENT WAS BROUGHT BACK TO THE OR. THE WOUND WAS CLEANED OUT AND RECLOSED. THE PATIENT CURRENTLY IS DOING FINE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21754002 ↗
• MalfunctionApr 2, 2025Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751531 ↗
• MalfunctionApr 2, 2025Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751519 ↗
• MalfunctionApr 2, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751487 ↗
• MalfunctionApr 2, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751474 ↗
• MalfunctionAug 15, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE NEEDLE WAS BREAKING WHILE BEING USED YESTERDAY. THE TEAM DID NOT KEEP THE SUTURE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990958 ↗
• MalfunctionAug 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE AND THE NEEDLE HAD BEEN DETACHED 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 19935331 ↗
• MalfunctionJul 12, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. NEEDLE POPPED OFF SUTURE IN A CASE. SUTURE WAS PULLED AND REPLACED WITH DIFFERENT STRAND AND NEEDLE. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729333 ↗
• MalfunctionJul 12, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. NEEDLE POPPED OFF SUTURE IN A CASE. SUTURE WAS PULLED AND REPLACED WITH DIFFERENT STRAND AND NEEDLE. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729241 ↗
• MalfunctionJul 12, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. NEEDLE POPPED OFF SUTURE IN A CASE. SUTURE WAS PULLED AND REPLACED WITH DIFFERENT STRAND AND NEEDLE. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729133 ↗
• MalfunctionJul 12, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. NEEDLE POPPED OFF SUTURE IN A CASE. SUTURE WAS PULLED AND REPLACED WITH DIFFERENT STRAND AND NEEDLE. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729131 ↗
• MalfunctionJul 12, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. NEEDLE POPPED OFF SUTURE IN A CASE. SUTURE WAS PULLED AND REPLACED WITH DIFFERENT STRAND AND NEEDLE. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729129 ↗
• MalfunctionJul 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USES. DURING THE PROCEDURE, THE CONNECTION PART OF THE NEEDLE AND THE SUTURE WAS BROKEN WITH LIGHT FORCE. THE SUTURE BROKE CLOSE TO THE SWAGE AREA. 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 19720852 ↗
• MalfunctionJul 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USES. DURING THE PROCEDURE, THE CONNECTION PART OF THE NEEDLE AND THE SUTURE WAS BROKEN WITH LIGHT FORCE. THE SUTURE BROKE CLOSE TO THE SWAGE AREA. 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 19720562 ↗
• MalfunctionJun 5, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON 26-APRIL-2024 AND SUTURE WAS USED. DURING THE SURGERY, THE CONNECTION PART OF THE NEEDLE AND SUTURE WAS BROKEN EASILY. 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 19469506 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING SURGERY, THE CONNECTION PART OF NEEDLE AND SUTURE WAS BROKEN EASILY AT THE PROXIMAL PART. 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 19454745 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON 10-MAY-2024 AND SUTURE WAS USED. DURING SURGERY, THE CONNECTION PART OF NEEDLE AND SUTURE WAS BROKEN EASILY AT THE PROXIMAL PART. 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 19454735 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON 10-MAY-2024 AND SUTURE WAS USED. DURING SURGERY, THE CONNECTION PART OF NEEDLE AND SUTURE WAS BROKEN EASILY AT THE PROXIMAL PART. 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 19454731 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING SURGERY, THE CONNECTION PART OF NEEDLE AND SUTURE WAS BROKEN EASILY AT THE PROXIMAL PART. 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 19454721 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON 10-MAY-2024 AND SUTURE WAS USED. DURING SURGERY, THE CONNECTION PART OF NEEDLE AND SUTURE WAS BROKEN EASILY AT THE PROXIMAL PART. 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 19454711 ↗
• MalfunctionFeb 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPIC UROLOGICAL ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE SURGERY, AFTER OPENING THE PACKAGE AND BEFORE USE, WHEN PASSING THE NEEDLE THROUGH THE TROCAR, ONLY THE SUTURE COULD BE PASSED INTO THE ABDOMINAL CAVITY, AND THE NEEDLE REMAINED INSIDE THE TROCAR. THE NEEDLE CAUGHT IN THE TROCAR DID NOT FALL INTO THE BODY. THE SURGEON SAID THAT THEY DIDN'T FEEL LIKE ANYTHING WAS CAUGHT. IT WAS NOT 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 18783969 ↗
• MalfunctionSep 8, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2023 AND SUTURE WAS USED. WHEN ATTENDING NOTED THAT THE 0-CT-1 TIP WAS BROKEN OFF AND THE C-SECTION WAS PAUSED AT THE TIME TO HAVE A STAT ABD X-RAY TO SEE IF THE TIP OF THE NEEDLE CAN BE SEEN ON THE X-RAY. CHARGE RN AND CIRCULATING RN IN OR WITH PATIENT. X-RAY CAME TO OR 2, DID THE XRAY AND THE ATTENDING AND X-RAY TECH DETERMINED THAT THERE WAS NO NEEDLE TIP IN THE PATIENT. MDS CONTINUED WITH C-SECTION AT THIS TIME. THE RADIOLOGIST DID A FINAL READ ON THE XRAY AND DETERMINED THERE WAS NO FOREIGN BODY LEFT IN THE PATIENT. INCISION CLOSED AND DRESSING APPLIED BY MD. ALL COUNTS WERE CORRECT IN THE OR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17715740 ↗
• MalfunctionMar 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE SUTURE BREAKS EASILY DURING REPAIR, SURGERY, CESAREAN SECTION. THE IMPACT OF THE PRODUCT WAS RISK OF WOUND DEHISCENCE IN POST-OP AND, COMPLICATION DURING REPAIR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656312 ↗