Coated VICRYL VCP775DRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031055537), received between Dec 30, 2019 and Aug 29, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT CRANIOTOMY FOR TEMPORAL LOBECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE CLOSING OF THE INCISION, THEY THEN TOOK A CT-SCAN OF THE HEAD AND DISCOVERED A FOREIGN MATERIAL. THEY BROUGHT THE PATIENT BACK TO THE SURGERY ROOM AND REOPENED THE HEAD AND FOUND A BROKEN PIECE OF THE NEEDLE ON THE DURA. THEY CLOSED UP THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22921126 ↗
• MalfunctionMar 4, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A CRANIOTOMY ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE BROKE. CASE WAS COMPLETED. NO PATIENT HARM WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. THE PIECES WERE RECOVERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21515943 ↗
• MalfunctionDec 30, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC ANKLE PROCEDURE ON AN UNKNOWN DATE ON (B)(6) 2022 AND SUTURE WAS USED. THERE WAS A POSSIBILITY THAT THE NEEDLE WAS BROKEN WHEN THE SUBCUTANEOUS WAS SUTURED. AT THAT TIME, THE SURGEON DID NOT REALIZE IT AND AFTER THE SURGERY WHEN AN X-RAY WAS TAKEN IT WAS CONFIRMED THAT THERE WAS A SHADOW LIKE A NEEDLE-TIP. THE NEEDLE WHICH WAS USED IN THE SURGERY WAS DISCARDED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16077495 ↗
• MalfunctionDec 22, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE EASIER THAN USUAL DURING USE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13063837 ↗
• MalfunctionNov 30, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL FUSION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE NURSE TRIED TO INSERT THE NEEDLE INTO THE SPONGE, IT WAS DIFFICULT TO BE INSERTED WHEN CHECKING THE NEEDLE TIP, IT WAS FOUND THAT THE NEEDLE TIP HAD BEEN BROKEN. THE WOUND WAS OPENED AND CLEANED AGAIN TO LOOK FOR THE NEEDLE TIP, BUT IT WAS NOT FOUND IN THE BODY. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. A POSTOPERATIVE CT SCAN WAS TAKEN, BUT THE NEEDLE TIP WAS NOT FOUND INSIDE THE BODY. THE PATIENT'S POSTOPERATIVE STATUS IS CURRENTLY NORMAL AS OF (B)(6). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12894739 ↗
• MalfunctionDec 30, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. IT WAS REPORTED THAT DIDN'T HAVE DETACHED THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, HOWEVER, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9530021 ↗

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