Coated VICRYL J316HRecalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 10705031038738), received between Mar 27, 2019 and Sep 2, 2026 — classified as 6 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Break” (56 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 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569814 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A QUADRANTECTOMY AND AXILLARY SENTINEL LYMPH NODE PROCEDURE FOR BREAST CANCER ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE QUADRANTECTOMY AND AXILLARY SENTINEL LYMPH NODE PROCEDURE FOR BREAST CANCER: THE CLOSURE OF THE QUADRANTECTOMY WAS PERFORMED. AT THE TIME OF SUTURING THE AXILLARY WOUND, IT WAS NOTICED THAT THE SUTURE NEEDLE WAS MISSING ITS FREE TIP. THE FRAGMENT WAS IMMEDIATELY FOUND ON THE FORCEPS IN USE AT THAT MOMENT AND MEASURED ABOUT 4 MM. DURING THE FINAL COUNT OF NEEDLES USED THROUGHOUT THE PROCEDURE, IT WAS NOTED THAT A SECOND NEEDLE HAD THE SAME ISSUE: MISSING TIP. THE PATIENT THEN UNDERWENT AN INTRAOPERATIVE X-RAY WHICH DID NOT SHOW THE PRESENCE OF ANY FOREIGN BODY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727653 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A QUADRANTECTOMY AND AXILLARY SENTINEL LYMPH NODE PROCEDURE FOR BREAST CANCER ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE QUADRANTECTOMY AND AXILLARY SENTINEL LYMPH NODE PROCEDURE FOR BREAST CANCER: THE CLOSURE OF THE QUADRANTECTOMY WAS PERFORMED. AT THE TIME OF SUTURING THE AXILLARY WOUND, IT WAS NOTICED THAT THE SUTURE NEEDLE WAS MISSING ITS FREE TIP. THE FRAGMENT WAS IMMEDIATELY FOUND ON THE FORCEPS IN USE AT THAT MOMENT AND MEASURED ABOUT 4 MM. DURING THE FINAL COUNT OF NEEDLES USED THROUGHOUT THE PROCEDURE, IT WAS NOTED THAT A SECOND NEEDLE HAD THE SAME ISSUE: MISSING TIP. THE PATIENT THEN UNDERWENT AN INTRAOPERATIVE X-RAY WHICH DID NOT SHOW THE PRESENCE OF ANY FOREIGN BODY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727573 ↗
• MalfunctionFeb 4, 2026Material Separation; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS TWISTED WHEN THE PACKAGE WAS OPENED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY FROM THE 1ST STITCH. 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. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260851 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE BROKE WHILE SUTURING TISSUE, THE BROKEN TIP WAS REMOVED FROM PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23682016 ↗
• MalfunctionAug 26, 2025Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A CESAREAN SECTION, WHILE THEY WERE SUTURING, THEY REALIZED THAT ONE OF THE SUTURES HAD A BLUNT NEEDLE. THEY DON'T KNOW IF IT WAS BLUNT OR IF IT HAD BROKEN DURING THE PROCEDURE. THEY TOOK A X-RAY OF THE PATIENT AND DIDN'T SEE ANYTHING. THEY'RE NOT SURE WHY I SAID IT WAS BLUNT OR IF IT HAD BROKEN INSIDE. THE OTHER SUTURES THEY OPENED FROM THE SAME BATCH WERE CORRECT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896579 ↗
• MalfunctionMay 28, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT THERE HAD BEEN DOUBLE-ARMED SUTURE THOUGH IT SHOULD BE SINGLE-ARMED SUTURE NORMALLY. THIS EVENT WAS FOUND BEFORE USE. THERE WAS NO PROBLEM TO THE PATIENT. 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 22097470 ↗
• MalfunctionJan 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS NO EXTENSION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21180380 ↗
• MalfunctionOct 30, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY; THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. PLEASE TAKE PHOTOS FOR JAPANESE CUSTOMER. AFFILIATE REFERENCE NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568379 ↗
• MalfunctionJul 19, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN UROLOGICAL SURGERY, WHEN USED FOR A CASE OF A ROBOT, THE SUTURE WAS BROKEN A CHOPPY. LOT NUMBER - UAMBPT OR UBMSAB - UNKNOWN IF THIS IS THE CORRECT LOT NUMBER. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19784062 ↗
• MalfunctionJul 19, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN UROLOGICAL SURGERY, WHEN USED FOR A CASE OF A ROBOT, THE SUTURE WAS BROKEN A CHOPPY. LOT NUMBER - UAMBPT OR UBMSAB - UNKNOWN IF THIS IS THE CORRECT LOT NUMBER. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19783868 ↗
• MalfunctionJul 10, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024, AND SUTURE WAS USED. THEY RECEIVED A BOX OF SUTURE THAT WAS PACKED IN THE BOX LABELED FOR A DIFFERENT PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710894 ↗
• MalfunctionJul 9, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. 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 19700435 ↗
• MalfunctionJun 19, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT GENERAL SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. THE NEEDLE CAME OFF DURING INTRACORPOREAL SUTURING. NO FRAGMENTS WERE GENERATED. A NEW SUTURE WAS OPENED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566493 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, BROKEN SUTURES FROM THE SAME LOT. IT HAPPENED 5 TIMES DURING THE SAME OPERATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003299 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, BROKEN SUTURES FROM THE SAME LOT. IT HAPPENED 5 TIMES DURING THE SAME OPERATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003296 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, BROKEN SUTURES FROM THE SAME LOT. IT HAPPENED 5 TIMES DURING THE SAME OPERATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003295 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, BROKEN SUTURES FROM THE SAME LOT. IT HAPPENED 5 TIMES DURING THE SAME OPERATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003286 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, BROKEN SUTURES FROM THE SAME LOT. IT HAPPENED 5 TIMES DURING THE SAME OPERATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003282 ↗
• MalfunctionJan 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL IMPLANT PLACEMENT PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURES KEEP BREAKING EASILY DURING PROCEDURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443958 ↗
• MalfunctionJan 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL IMPLANT PLACEMENT PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURES KEEP BREAKING EASILY DURING PROCEDURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443957 ↗
• MalfunctionJan 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL IMPLANT SECOND STAGE PLACEMENT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURES KEEP BREAKING EASILY DURING PROCEDURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443877 ↗
• MalfunctionJan 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL IMPLANT SECOND STAGE PLACEMENT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURES KEEP BREAKING EASILY DURING PROCEDURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443871 ↗
• MalfunctionNov 15, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 20-OCT-2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. ANOTHER LOT PRODUCT WAS USED. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18143048 ↗
• MalfunctionNov 15, 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 SUTURE WAS EASILY DETACHED FROM THE NEEDLE. ANOTHER LOT PRODUCT WAS USED. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18143040 ↗