Coated VICRYL J417HRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10705031039681), received between May 15, 2018 and Aug 6, 2026 — classified as 3 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Device Markings/Labelling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50158625 ↗
• InjuryAug 3, 2026Break

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 50123750 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM, (B)(4), THAT DURING AN UNKNOWN PROCEDURE, THE 2-0 VICRYL SH UNDYED SUTURE BROKE AT THE KNOT AFTER PROVIDER USED THEM AND CAREFULLY KNOTTED THEM DURING PROCEDURE. THERE WERE TWO DIFFERENT LOT NUMBERS IN USE ON THE CASE. DEVICES ARE NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324527 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM, (B)(4), THAT DURING AN UNKNOWN PROCEDURE, THE 2-0 VICRYL SH UNDYED SUTURE BROKE AT THE KNOT AFTER PROVIDER USED THEM AND CAREFULLY KNOTTED THEM DURING PROCEDURE. THERE WERE TWO DIFFERENT LOT NUMBERS IN USE ON THE CASE. DEVICES ARE NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324526 ↗
• MalfunctionFeb 3, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEMORRHOIDECTOMY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY MD THAT DURING A HEMORIDECTOMY, PRESENCE OF LARGE INTERNAL AND EXTERNAL HERMMORIDES WERE PRESENT. MD USED A 2-0 VICRYL SH TO TIE DOWN THE INTERNAL PEDICAL TO EXCISE HEMORRHOID. PATIENT WAS IN LATHOTOMY POSITION WHILE MD WENT TO PLACE DEEP STITCH IN, COULD NOT SEE NEEDLE AFTER 1ST THROW, WENT TO GRAB NEEDLE AND WHOLE NEED APPEARED TO COME OFF. SUTURE CAME OFF NEEDLE AND NEEDLE APPREARED TO BE BURIED. TISSUE HAD OBSCURED. CALLED FOR X-RAY AND SAW NEEDLE, MD COULD NOT SAFELY REMOVE THE NEEDLE WITHOUT CAUSING DAMAGE TO MUSCLE AND SURROUNDING TISSUE. MD TOOK PHOTO OF SUTURE THAT CARRIED NEEDLE AND METAL APPEARED TO HAVE FRACTURED. SUTURE AVAILABLE TO BE SENT BACK FOR ANALYSIS. MD SHARED EVENT OCCURRED BACK IN NOV/DEC OF 2025 HOWEVER EVENT WAS NOT REPORTED TO JNJ UNTIL 01/06/26. SURGICAL DELAY WAS UNKNOWN. MD IS CONTINUING TO EVALUATE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 24246350 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PENILE IMPLANT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A PENILE IMPLANT PROCEDURE, THE SUTURE BROKE AT THE KNOT AFTER THE SURGEON HAD TIED IT. AS A RESULT, THE SURGEON HAD TO REPEAT THE PROCEDURE MULTIPLE TIMES. THERE WERE NO REPORTED PATIENT CONSEQUENCES, AND THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066637 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PENILE IMPLANT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A PENILE IMPLANT PROCEDURE, THE SUTURE BROKE AT THE KNOT AFTER THE SURGEON HAD TIED IT. AS A RESULT, THE SURGEON HAD TO REPEAT THE PROCEDURE MULTIPLE TIMES. THERE WERE NO REPORTED PATIENT CONSEQUENCES, AND THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066635 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PENILE IMPLANT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A PENILE IMPLANT PROCEDURE, THE SUTURE BROKE AT THE KNOT AFTER THE SURGEON HAD TIED IT. AS A RESULT, THE SURGEON HAD TO REPEAT THE PROCEDURE MULTIPLE TIMES. THERE WERE NO REPORTED PATIENT CONSEQUENCES, AND THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066627 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PENILE IMPLANT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A PENILE IMPLANT PROCEDURE, THE SUTURE BROKE AT THE KNOT AFTER THE SURGEON HAD TIED IT. AS A RESULT, THE SURGEON HAD TO REPEAT THE PROCEDURE MULTIPLE TIMES. THERE WERE NO REPORTED PATIENT CONSEQUENCES, AND THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066613 ↗
• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE NEEDLE BROKE OFF WHEN BEING REPOSITIONED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336991 ↗
• InjuryMay 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PICC LINE INSERTION ON (B)(6) 2025 AND SUTURE WAS USED. POST-OP, ON (B)(6) 2025, THE PATIENT NOTED PURULENT DRAINAGE AT THE INSERTION SITE. THE PATIENT WAS PLACED ON ANTIBIOTICS FOR PORT INSERTION SITE INFECTION. THE SUTURE WAS TRIMMED PREVIOUSLY. IT WAS OPINED BY THE SURGEON THAT THERE COULD HAVE BEEN DELAYED SUTURE ABSORPTION. NO FURTHER PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 22090916 ↗
• MalfunctionMay 7, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING SET UP TO A BREAST CASE WHEN THE PACKAGE WAS OPENED IT APPEARED TO BE TAMPERED. THERE WERE DOODLES ON THE PACKAGING AND TAPE ON THE INSIDE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976125 ↗
• MalfunctionDec 1, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE NEEDLE BROKE WHILE USING IT IN A PROCEDURE IN THE CATH LAB. NO PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18251129 ↗
• MalfunctionDec 16, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. WHEN THEY OPENED THE BOX, THERE WAS THE WRONG SUTURE IN THE BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000437 ↗
• MalfunctionOct 31, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN SEPTEMBER 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF AND WAS RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705533 ↗
• MalfunctionJul 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WERE USED. DURING SURGERY WHILE CLOSING THE INCISION THE SUTURE NEEDLE BROKE IN HALF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15044659 ↗
• MalfunctionJun 22, 2022Break

  DURING SURGERY WHILE CLOSING THE INCISION THE SUTURE NEEDLE BROKE IN HALF.

  Patient problems: Insufficient Information

  MAUDE report 14772662 ↗
• MalfunctionMar 29, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPS OFF WHEN IT SHOULDN'T. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935370 ↗
• MalfunctionMar 29, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPS OFF WHEN IT SHOULDN'T. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935362 ↗
• MalfunctionMar 29, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPS OFF WHEN IT SHOULDN'T. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935247 ↗
• MalfunctionMar 29, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPS OFF WHEN IT SHOULDN'T. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935221 ↗
• MalfunctionOct 25, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS TO BE USED. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE PRODUCT IS BROKEN/DAMAGED AND STERILITY IS COMPROMISED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12689555 ↗
• MalfunctionSep 21, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE AND THE NEEDLE TIP WAS RETRIEVED.. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12508464 ↗
• MalfunctionJul 6, 2021Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, ON THREE OF THE SUTURE BOXES THE NEEDLE WAS POPPING OF AND OR SUTURE BREAKING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12122842 ↗
• MalfunctionApr 21, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF CYST PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THE NEEDLE BROKE INSIDE THE PATIENT. X-RAY LOCATED THE FRAGMENT, AND IT WAS REMOVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703744 ↗