Coated VICRYL J260HRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10705031038332), received between Jun 27, 2019 and May 21, 2026 — classified as 2 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Material Separation” (19 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.

• MalfunctionMay 21, 2026Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE DL BY THE HEALTHCARE PROFESSIONAL THAT SURGEON USING IN ROBOTIC CASE AND NEEDLE BROKE OFF. FOUND IT AND RETRIEVED. OPENED A NEW ONE AND IT BROKE IN HALF. SECOND TIME NEEDLE COULDN'T BE FOUND. SAME LOT NUMBER. THERE IS ADVERSE IMPACT ON PATIENT/USER REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 25240843 ↗
• MalfunctionMar 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE SITE OPENED 2 OF THIS SAME LOT# AND THE NEEDLES OF BOTH OF THESE BUSTED IN HALF WHILE THE SURGEON WAS STITCHING UP THE ABDOMEN. INJURIES OR ADVERSE EVENT: YES. SAMPLES AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638595 ↗
• MalfunctionMar 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE SITE OPENED 2 OF THIS SAME LOT# AND THE NEEDLES OF BOTH OF THESE BUSTED IN HALF WHILE THE SURGEON WAS STITCHING UP THE ABDOMEN. INJURIES OR ADVERSE EVENT: YES. SAMPLES AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638592 ↗
• MalfunctionJul 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THE SUTURE NEEDLE BROKE. CASE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM WAS REPORTED. DEVICE WAS DISCARDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478693 ↗
• MalfunctionMar 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL VAGINAL HYSTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, UPON VAGINAL CUFF CLOSURE, THE SUTURE BROKE AWAY FROM THE NEEDLE. WHEN APPLYING TENSION AFTER THE SURGEON TAKES A BITE, WHEN THEY GRASP THE SUTURE IS POPPING OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632646 ↗
• MalfunctionMar 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL VAGINAL HYSTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, UPON VAGINAL CUFF CLOSURE, THE SUTURE BROKE AWAY FROM THE NEEDLE. WHEN APPLYING TENSION AFTER THE SURGEON TAKES A BITE, WHEN THEY GRASP THE SUTURE IS POPPING OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632637 ↗
• MalfunctionJan 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT SEVERAL POP OFFS DURING AN OR. PRODUCT REPLACED WITH A NEW BOX OF THE SAME PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241732 ↗
• MalfunctionJan 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT SEVERAL POP OFFS DURING AN OR. PRODUCT REPLACED WITH A NEW BOX OF THE SAME PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241521 ↗
• MalfunctionJan 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT SEVERAL POP OFFS DURING AN OR. PRODUCT REPLACED WITH A NEW BOX OF THE SAME PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241512 ↗
• MalfunctionJan 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT SEVERAL POP OFFS DURING AN OR. PRODUCT REPLACED WITH A NEW BOX OF THE SAME PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241510 ↗
• MalfunctionSep 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE TIP OF THE NEEDLE HAD BROKEN OFF. THEY WERE ABLE TO RETRIEVE THE TIP AND COMPLETE THE CASE WITH A SECOND ONE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291124 ↗
• MalfunctionMar 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT CUSTOMER ORDERED (B)(4) BOXES OF THE ITEM LISTED AND ONLY OPENED (B)(4) BOXES. THE (B)(4) BOX WAS DEFECTIVE, THE SUTURES KEPT BREAKING OFF. THEY OPENED A NEW BOX AND THERE WERE NO ISSUES WITH THE (B)(4) BOX. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003761 ↗
• MalfunctionMar 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT CUSTOMER ORDERED 4 BOXES OF THE ITEM LISTED AND ONLY OPENED 2 BOXES. THE FIRST BOX WAS DEFECTIVE, THE SUTURES KEPT BREAKING OFF. THEY OPENED A NEW BOX AND THERE WERE NO ISSUES WITH THE SECOND BOX. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003759 ↗
• MalfunctionFeb 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, 4 OF THE SUTURES BROKE IN HALF WHILE SUTURING ON TODAY'S CASE AND MULTIPLE OTHER SURGEONS HAVE BEEN COMPLAINING ABOUT THE SAME ISSUE. IT IS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658159 ↗
• MalfunctionFeb 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, 4 OF THE SUTURES BROKE IN HALF WHILE SUTURING ON TODAY'S CASE AND MULTIPLE OTHER SURGEONS HAVE BEEN COMPLAINING ABOUT THE SAME ISSUE. IT IS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658029 ↗
• MalfunctionFeb 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, 4 OF THE SUTURES BROKE IN HALF WHILE SUTURING ON TODAY'S CASE AND MULTIPLE OTHER SURGEONS HAVE BEEN COMPLAINING ABOUT THE SAME ISSUE. IT IS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658024 ↗
• MalfunctionFeb 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, 4 OF THE SUTURES BROKE IN HALF WHILE SUTURING ON TODAY'S CASE AND MULTIPLE OTHER SURGEONS HAVE BEEN COMPLAINING ABOUT THE SAME ISSUE. IT IS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658019 ↗
• MalfunctionFeb 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, 4 OF THE SUTURES BROKE IN HALF WHILE SUTURING ON TODAY'S CASE AND MULTIPLE OTHER SURGEONS HAVE BEEN COMPLAINING ABOUT THE SAME ISSUE. IT IS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18657950 ↗
• MalfunctionJan 12, 2024Material 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 SALES REP REPORTED THAT THE NEEDLES POPPED OFF DURING A C-SECTION CASE. THEY WERE ABLE TO COMPLETE THE CASE WITH NO PATIENT HARM. DEVICES ARE AVAILABLE TO BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18501914 ↗
• MalfunctionJan 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR STATED THE NEEDLE HAS POPPED OFF ALL THE SUTURES HE HAS USED FROM THE BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489089 ↗
• MalfunctionJan 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR STATED THE NEEDLE HAS POPPED OFF ALL THE SUTURES HE HAS USED FROM THE BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489033 ↗
• MalfunctionNov 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE KEEPS POPPING OFF FROM THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182803 ↗
• MalfunctionNov 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE KEEPS POPPING OFF FROM THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182792 ↗
• MalfunctionNov 17, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 20-OCT-2023 AND SUTURE WAS USED. THE NEEDLE POPPED OFF FROM THE SUTURE. THERE WERE NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18163460 ↗
• MalfunctionNov 17, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 20-OCT-2023 AND SUTURE WAS USED. THE NEEDLE POPPED OFF FROM THE SUTURE. THERE WERE NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18163448 ↗