Coated VICRYL VCP416H (UDI 10705031078147)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031078147), received between Dec 4, 2019 and Mar 24, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE IS BREAKING. THERE WERE THREE OF THESE IN THE SAME PROCEDURE. NO ADVERSE IMPACT PATIENT/USER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681381 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE IS BREAKING. THERE WERE THREE OF THESE IN THE SAME PROCEDURE. NO ADVERSE IMPACT PATIENT/USER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675475 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE IS BREAKING. THERE WERE THREE OF THESE IN THE SAME PROCEDURE. NO ADVERSE IMPACT PATIENT/USER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675474 ↗
• MalfunctionMar 17, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE PEDIATRIC SURGERY AND ENDOSCOPY MANAGER THAT TWO CONSECUTIVE NEEDLE TIPS OF THE SUTURE BROKE OFF DURING A CASE. NURSE STATES THAT NEEDLE TIP BROKE OFF WHEN GRABBED AFTER PULLING THROUGH TISSUE IN AN ORTHO PROCEDURE ON THE SUBCUTANEOUS LAYER. BROKEN TIP HAD TO BE RETRIEVED FROM PATIENT. THERE WAS A 5MIN OF SURGICAL DELAY REPORTED. BOTH DEVICES WERE RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24618004 ↗
• MalfunctionMar 17, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE PEDIATRIC SURGERY AND ENDOSCOPY MANAGER THAT TWO CONSECUTIVE NEEDLE TIPS OF THE SUTURE BROKE OFF DURING A CASE. NURSE STATES THAT NEEDLE TIP BROKE OFF WHEN GRABBED AFTER PULLING THROUGH TISSUE IN AN ORTHO PROCEDURE ON THE SUBCUTANEOUS LAYER. BROKEN TIP HAD TO BE RETRIEVED FROM PATIENT. THERE WAS A 5MIN OF SURGICAL DELAY REPORTED. BOTH DEVICES WERE RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24617994 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN ABDOMINAL SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF. AND IT WAS FOUND DURING X-RAY. THE NEEDLE PIECE WAS RETRIEVED DURING THE PROCEDURE AND RADIOLOGY WAS CALLED IN TO PERFORM AN X-RAY AND NO ADDITIONAL NEEDLE PIECES WERE FOUND INSIDE THE BODY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24548418 ↗
• MalfunctionFeb 24, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE DEVICE WAS RECEIVED WITH NO COMPLAINT INFORMATION. ATTEMPTS WERE MADE TO RECONCILE THE DEVICE WITH NO SUCCESS RESULTING IN THE CREATION OF A NEW COMPLAINT. UPON EVALUATION OF THE RETURNED DEVICE, A FRACTURE WAS OBSERVED IN THE BODY OF THE NEEDLE. THE NEEDLE WAS RECEIVED IN TWO PIECES, ONLY ONE OF THE MATING FRACTURE SURFACES WAS EXAMINED FOR THIS EVALUATION. A SCANNING ELECTRON MICROSCOPE (SEM) WAS USED TO EXAMINE THE FRACTURE SURFACES AND SURROUNDING AREA OF THE NEEDLE. THE FRACTURE SURFACES WERE EXAMINED IN MULTIPLE LOCATIONS TO DETERMINE THE FRACTURE MODE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430071 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT DURING CLOSURE, THE PROVIDER NOTED A SUTURE NEEDLE TIP HAD BROKEN. THE PROCEDURE WAS PAUSED, INTRAOPERATIVE X-RAY CONFIRMED THE FRAGMENT LOCATION, AND IT WAS SUCCESSFULLY RETRIEVED. A SECOND X-RAY VERIFIED NO REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION. THERE IS NO INJURY OR HARM TO THE PATIENT REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23965607 ↗
• MalfunctionDec 18, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY ORDERED 2 MORE BOXES OF THE VCP416H 3-0 VICRYL SH AND THE CAME IN DYED AGAIN. THIS AN UNDYED SUTURE BUT THE LABEL STATES DYED. PRODUCTS ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837045 ↗
• MalfunctionSep 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A EXCISION OF LESION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING EXCISION OF LESION PROCEDURE THEY NOTICED THAT THE NEEDLE TIP BROKE OFF ON THE NEEDLE THEY FOUND IT ON THE MAYO STAND NOT ON THE PATIENT. CASE WAS COMPLETED BY OPENING A NEW ONE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057508 ↗
• MalfunctionApr 23, 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 BY THE HEALTHCARE PROFESSIONAL THAT WHILE SUTURING THE PATIENT'S SKIN, THE SURGEON STATED THAT THE VERY TIP OF THE NEEDLE BROKE OFF THE MAIN NEEDLE. NO INJURY, REACHED THE INDIVIDUAL BUT DID NOT CAUSE HARM. THE SAMPLE WAS DISCARDED IN THE SHARPS CONTAINER AFTER USE. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894378 ↗
• MalfunctionDec 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND THE SUTURE WAS USED. IT WAS ALSO REPORTED THAT THE NEEDLE WAS MISSING FROM SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9411247 ↗
• MalfunctionDec 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND THE SUTURE WAS USED. IT WAS ALSO REPORTED THAT THE NEEDLE WAS MISSING FROM SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9411144 ↗