Coated VICRYL J370HRecalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 10705031039377), received between Apr 16, 2019 and Oct 27, 2025 — classified as 106 malfunctions.

The most frequently reported specific device problem is “Material Separation” (83 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 106 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE SNAPPED OFF THREAD WHILE SUTURING ¿ IS ONLY INFORMATION PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393384 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, 3 SUTURES FROM THIS BOX USED IN OR AND NEEDLE BROKE OFF SUTURE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291864 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, 3 SUTURES FROM THIS BOX USED IN OR AND NEEDLE BROKE OFF SUTURE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291712 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, 3 SUTURES FROM THIS BOX USED IN OR AND NEEDLE BROKE OFF SUTURE THREAD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291348 ↗
• MalfunctionNov 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. PER USER FACILITY MEDWATCH FORM #(B)(4) DURING THE CESAREAN SECTION REPEAT PROCEDURE, THE PHYSICIAN WAS SUTURING THE UTERUS CLOSED WHEN THE NEEDLE CAME OFF THE END OF THE SUTURE. THE NEEDLE FELL OFF INSIDE THE UTERUS, PHYSICIAN HAD TO REACH IN AND FIND THE NEEDLE. THE NEEDLE WAS RECOVERED, AND PACKAGING SAVED. THE SUTURE REMAINED IN THE UTERUS. ALL COUNTS WERE CORRECT. THE DEVICE WAS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20669674 ↗
• MalfunctionOct 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SALES REP IS REPORTING FROM THE CUSTOMER THAT THE NEEDLE BROKE DURING AN UNKNOWN PROCEDURE. THEY WERE ABLE TO RETRIEVE THE BROKEN PIECE AND REMOVED THE REMAINING SUTURES FROM THE SAME LOT. NO PATIENT HARM. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20510117 ↗
• MalfunctionOct 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE BROKE DURING A PROCEDURE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20507655 ↗
• MalfunctionSep 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE MYOMETRIUM. DURING THE PROCEDURE, WITH CONTINUOUS SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241309 ↗
• MalfunctionDec 7, 2023Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6). 2023 AND SUTURE WAS USED. THE SUTURE MATERIAL WAS FRAYED ABOUT 4INCH FROM NEEDLE, AND SUTURE MATERIAL WAS COMING APART FROM THE NEEDLE EASILY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287210 ↗
• MalfunctionDec 7, 2023Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE MATERIAL WAS FRAYED ABOUT 4INCH FROM NEEDLE, AND SUTURE MATERIAL WAS COMING APART FROM THE NEEDLE EASILY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287136 ↗
• MalfunctionDec 7, 2023Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE MATERIAL WAS FRAYED ABOUT 4INCH FROM NEEDLE, AND SUTURE MATERIAL WAS COMING APART FROM THE NEEDLE EASILY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287131 ↗
• MalfunctionOct 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING USE. THIS HAPPENED THREE TIMES IN A ROW. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17946036 ↗
• MalfunctionOct 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING USE. THIS HAPPENED THREE TIMES IN A ROW. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17945995 ↗
• MalfunctionOct 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING USE. THIS HAPPENED THREE TIMES IN A ROW. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17945979 ↗
• MalfunctionAug 31, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND A SUTURE WAS USED. THE NEEDLE TIP BROKE OFF BEFORE USED THE SUTURE ON THE PATIENT. THE NEEDLE IS IN PIECES. UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. UPON RECEIPT AND ANALYSIS, IT WAS NOTED A BREAKAGE OCCURRED AND MARKS INDICATED TO BE BY SURGICAL INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666273 ↗
• 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, THE SUTURE BREAKING OFF AT THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240473 ↗
• MalfunctionJun 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 06/09/2023 AND SUTURE WAS USED. THE SUTURE WAS BREAKING OFF AT NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199409 ↗
• MalfunctionMar 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A AN UNKNOWN OB-GYN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A C-SECTION, THE SUTURE WAS DETACHED FORM THE NEEDLE DURING CONTINUOUS SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THE PRODUCT WAS USED ON MYOMETRIUM. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537082 ↗
• MalfunctionMar 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A C-SECTION, THE SUTURE WAS DETACHED FORM THE NEEDLE DURING CONTINUOUS SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THE PRODUCT WAS USED ON MYOMETRIUM. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537068 ↗
• MalfunctionMar 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING CONTINUOUS SUTURING ON MYOMETRIUM. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501646 ↗
• MalfunctionFeb 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE DURING CONTINUOUS SUTURING ON FASCIA. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16389333 ↗
• MalfunctionFeb 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE DURING CONTINUOUS SUTURING ON FASCIA. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16388767 ↗
• MalfunctionFeb 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON 2/9/2023 AND SUTURE WAS USED. THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE DURING CONTINUOUS SUTURING ON FASCIA. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16388751 ↗
• MalfunctionJan 5, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. DURING USE THE DOCTOR WAS SEWING IN AN UPWARD MOTION WHEN TECHNICIAN NOTICED SOMETHING FLY UP AND OFF THE TIP OF THE NEEDLE DRIVER. SHE SPOKE UP AND ASKED WHAT IT WAS AND THE DOCTOR PAUSED THE CASE, LOOKING AROUND ON THE FIELD. THEY DISCOVERED THE BACK END OF THE NEEDLE WAS MISSING FROM THE DRIVER. THE BACK HALF OF THE NEEDLE WAS LOCATED ON THE FIELD. ALL PARTS OF THE NEEDLE WERE RECOVERED AND THE NEEDLE WAS DISCARDED. NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16101637 ↗
• MalfunctionDec 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE SUTURING UNKNOWN TISSUE. IT WAS UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15987756 ↗