Coated VICRYL VCP416H (UDI 10705031053014)Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10705031053014), received between Jan 3, 2019 and May 4, 2026 — classified as 13 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Break” (37 reports).

2 other recalls cover devices cleared under the same FDA submission (K032420, K132580, K181652); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT HEMICOLECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING ROBOTIC RIGHT HEMICOLECTOMY PROCEDURE, THE SUTURE DISENGAGED FROM THE NEEDLE AND POPPED OFF MID-CASE. THE SUTURE COULD NOT BE IMMEDIATELY LOCATED WITHIN THE SURGICAL FIELD. AS A PRECAUTIONARY MEASURE, AN INTRAOPERATIVE X-RAY OF THE PATIENT¿S ABDOMEN WAS PERFORMED TO LOCATE THE MISSING SUTURE AND THE PROCEDURE TIME WAS LONGER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068093 ↗
• MalfunctionMar 18, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING AN UNKNOWN PROCEDURE STAFF REPORTED THAT UPON OPENING THE PACKAGE, THEY OBSERVED A BLACK SPECK INSIDE. DUE TO THE PRESENCE OF THIS FOREIGN MATERIAL, THE STERILITY OF THE PRODUCT COULD NOT BE CONFIRMED. NO PATIENT CONSEQUENCES. UNKNOWN PROCEDURE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634182 ↗
• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, 3-0 VICRYL SUTURE BROKE IN HALF DURING USE, IN SOFT TISSUE. PIECE WAS EMBEDDED IN [REDACTED] UNTIL LOCATED BY SURGEON AND REMOVED. LOT: 1099 EP, REF: VCP416, EXP: 05/31/2030. VCL+ UD 27IN 3-0 S/A SH - VCP416H (LOT: 1099EP) (VCP416H): RIGHT SIDE. VCL+ UD 27IN 3-0 S/A SH - VCP416H (LOT: 1099EP) (VCP416H): LOT/BATCH NUMBER: 1099EP. LIST ANY J&J PRODUCTS THAT WERE UTILIZED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. WAS THERE ANY REPORTED PATIENT OR USER HARM? NO. WAS THERE A SIGNIFICANT DELAY? NO. IF AVAILABLE, PROVIDE THE PRODUCT ORDER NUMBER (PO). DO YOU NEED PRODUCT PACKAGING TO SEND THE PRODUCT BACK? NO. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24153286 ↗
• MalfunctionJan 15, 2026Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENT (EAR, NOSE, AND THROAT) PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS FRAYED WHERE THE NEEDLE MEETS THE SUTURE. THE SUTURE SEPARATED FROM THE NEEDLE. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085730 ↗
• MalfunctionDec 19, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT REPLACEMENT SUTURE CAME IN, BUT IT IS 50% CORRECT. ONE BOX UNDYED, ONE BOX DYED. THIS IS THE THIRD TIME ISSUE. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849610 ↗
• MalfunctionDec 10, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THE COSTUMER ORDER 3 BOXES OF AND UNDYED VICRYL SUTURE AND RECEIVED TWO SUTURE THAT WAS MISLABELED TO DYED. THEY RE-ORDER AND RECEIVED THE CORRECT PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770637 ↗
• MalfunctionDec 10, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THE COSTUMER ORDER 3 BOXES OF AND UNDYED VICRYL SUTURE AND RECEIVED TWO SUTURE THAT WAS MISLABELED TO DYED. THEY RE-ORDER AND RECEIVED THE CORRECT PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770636 ↗
• MalfunctionOct 27, 2025Break

  SURGICAL PROVIDER SUTURING PERINEAL/VAGINAL AREA AND PORTION OF NEEDLE BROKE OFF, ROOM SEARCHED, PELVIC RADIOGRAPHS TAKEN AND RADIOLOGIST REVIEWED, FINAL IMPRESSION NOTED AN OBJECT MEASURING 1.1 CM OVER THE MIDLINE VAGINAL SOFT TISSUE REGION, LIKELY REPRESENTING UNACCOUNTED FOR SURGICAL NEEDLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23390457 ↗
• MalfunctionOct 20, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE SALES REP THAT, HE SAW FROM A ORLIFE INTERNET WEBSITE PAGE A POST OF A CUSTOMER A ETHICON SUTURE HAS TWO NEEDLES IN THE PACKAGE INSTEAD OF ONE. THERE WAS NO PATIENT INVOLVEMENT. NO PRODUCT IS FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336357 ↗
• MalfunctionOct 17, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE SALES REP THAT, HE SAW FROM A OR LIFE INTERNET WEBSITE PAGE A POST OF A CUSTOMER AN ETHICON SUTURE HAS TWO NEEDLES IN THE PACKAGE INSTEAD OF ONE. THERE WAS NO PATIENT INVOLVEMENT. NO PRODUCT IS FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23327703 ↗
• MalfunctionSep 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT DURING SURGERY, THE NEEDLE TIP HAD BROKEN AS ATTACHED DURING SEWING. CHANGED ANOTHER ONE TO COMPLETE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23178865 ↗
• MalfunctionSep 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT SUTURE NEEDLE BROKE INTO THREE PIECES DURING ABOVE KNEE AMPUTATION. NO EXTRACURRICULAR FORCE WAS APPLIED, SUTURE SEEMED TO BE BEING USED IN NORMAL TECHNIQUE. NEEDLE PIECES LOCATED WITHIN FIELD AND REMOVED. PROCEDURE WAS DELAYED BY 5 MINUTES. NO PATIENT HARM WAS REPORTED. ONE DEVICE IS RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23118361 ↗
• MalfunctionSep 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT EXPLORATORY LAPAROTOMY/TUMOR DEBULKING AND HYSTERECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE DURING REPAIR OF THE SMALL BOWEL ENTEROTOMY. THEY SAID IT SPLIT AT THE SHARP POINT OF THE NEEDLE. SURGEON DIDN'T KNOW WHEN IT HAPPENED. SCRUB TECH NOTICED WHEN THEY WERE SUTURING. THE NEEDLE FELL INTO THE PATIENT AS IT WAS A ROBOTIC PROCEDURE WHERE THE SUTURE WAS INSIDE THE PATIENT WHEN THE SURGICAL TECH NOTICED THAT THE NEEDLE WAS BROKEN. THE NEEDLE PIECES WERE RETRIEVED DURING THE SAME PROCEDURE. THE BROKEN NEEDLE AND NEEDLE PIECES WERE REMOVED FROM THE PATIENT AND WERE REPLACED WITH ANOTHER SUTURE. THE PROCEDURE CONTINUED AS PLANNED AND THE SURGEON WAS NOT CONCERNED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042280 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT, THE RESIDENT USED A NON-EXPIRED SUTURE FOR CLOSURE, AND PART OF THE NEEDLE BROKE. THEY IMMEDIATELY FOUND A BROKEN PIECE AND TOOK SOME TIME TO LOCATE THE REMAINING NEEDLE. AFTER COMPARING IT WITH A NEW SUTURE, IT WAS CONFIRMED THAT NO REMAINING NEEDLE FRAGMENTS WERE IN THE PATIENT. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22906375 ↗
• MalfunctionAug 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. SUTURE NEEDLE CAME OFF SUTURE DURING CASE. NO INJURIES OR ADVERSE EVENT ON PATIENT IS NOTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905996 ↗
• InjuryJul 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE ACCOUNT HAS SEEN FOUR INFECTIONS ASSOCIATED WITH ABSORBABLE HEMOSTAT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 22442067 ↗
• MalfunctionMar 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HERNIA PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A ROBOTIC HERNIA, ON THIS SUTURE THE NEEDLE IS POPPING OFF PREMATURELY AND IT IS A SWEDGED ON SUTURE. CASE WAS COMPLETED WITH A LIKE DEVICE. DEVICE WAS DISCARDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546410 ↗
• MalfunctionJan 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY PROCEDURE ON (B)(6) 2024 AND A SUTURE WAS USED. THE SUTURE NEEDLE BROKE OFF THE SUTURE STRAND DURING REPAIR AND WAS LODGED IN THE PATIENTS PERINEUM. NEEDLE WAS RECOVERED. UNKNOWN IF X-RAY WAS NEEDED TO RECOVER THE NEEDLE. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21183789 ↗
• MalfunctionJan 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEMORRHOIDECTOMY PROCEDURE ON (B)(6) 2024 AND A SUTURE WAS USED. THE NEEDLE BROKE WHILE SUTURING UNKNOWN TISSUE. FRAGMENT WAS NOT RECOVERED. NO X-RAY WAS DONE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173132 ↗
• MalfunctionDec 30, 2024Material 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 THE NEEDLE CAME OFF OF THE SUTURE. THEY WERE ABLE TO RETRIEVE THE NEEDLE AND COMPLETE THE CASE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037121 ↗
• MalfunctionDec 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC INGUINAL HERNIA REPAIR PROCEDURE IN 2024 AND SUTURE WAS USED. THE SUTURE KEPT COMING OFF THE SUTURE DURING THE CASE (TWO NEEDLES POPPED OFF DURING USE IN THE CASE). A DIFFERENT NEW SUTURE WAS USED TO COMPLETE THE CASE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919251 ↗
• MalfunctionDec 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC INGUINAL HERNIA REPAIR PROCEDURE IN 2024 AND SUTURE WAS USED. THE SUTURE KEPT COMING OFF THE SUTURE DURING THE CASE (TWO NEEDLES POPPED OFF DURING USE IN THE CASE). A DIFFERENT NEW SUTURE WAS USED TO COMPLETE THE CASE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20916921 ↗
• MalfunctionNov 8, 2024Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE DEVICE WAS USED. THE PRODUCT WAS BREAKING AND FRAYING DURING THE CASE. NOTHING FELL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641492 ↗
• MalfunctionNov 8, 2024Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE DEVICE WAS USED. THE PRODUCT WAS BREAKING AND FRAYING DURING THE CASE. NOTHING FELL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641422 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY ON (B)(6) 2024 AND SUTURE WAS USED. DURING A MASTECTOMY, THE NEEDLE BROKE OFF IN THE PATIENT. THEY WERE ABLE TO RETRIEVE THE NEEDLE WITHOUT INTERVENTION. CASE COMPLETED WITH ANOTHER SUTURE FROM THE SAME LOT. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156814 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032420, K132580, K181652. One submission often covers many models, so check the product and lot details in each record.

• Z-2145-2024 · May 10, 2024 · Open, Classified
  VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological
• Z-1310-2009 · Feb 2, 2009 · Terminated
  Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and