Coated VICRYL VCP713DRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705031054998), received between Apr 24, 2019 and Feb 24, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN LAPAROSCOPIC SURGERY, WHEN THE PRODUCT WAS OPENED AND CONFIRMED, IT WAS FOUND BEFORE USE THAT THERE HAD BEEN A FOREIGN MATERIAL ATTACHED TO THE NEEDLE WHICH WAS AT THE POSITION ¿8¿. IT COULD BE CONFIRMED THAT THERE IS FOREIGN MATERIAL SLIGHTLY. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. LOT NUMBER - 10A070 - UNKNOWN IF THIS IS THE CORRECT LOT NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433343 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING CLOSING THE HEAD, IT WAS TRIED TO SUTURE AND THEN LIGATE, BUT THE SUTURE WAS BROKEN. DETAILS ARE BEING CONFIRMED. 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 20792210 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING CLOSING THE HEAD, IT WAS TRIED TO SUTURE AND THEN LIGATE, BUT THE SUTURE WAS BROKEN. DETAILS ARE BEING CONFIRMED. 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 20791361 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING CLOSING THE HEAD, IT WAS TRIED TO SUTURE AND THEN LIGATE, BUT THE SUTURE WAS BROKEN. DETAILS ARE BEING CONFIRMED. 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 20790758 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING CLOSING THE HEAD, IT WAS TRIED TO SUTURE AND THEN LIGATE, BUT THE SUTURE WAS BROKEN. DETAILS ARE BEING CONFIRMED. 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 20790225 ↗
• MalfunctionNov 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING CLOSING THE HEAD, IT WAS TRIED TO SUTURE AND THEN LIGATE, BUT THE SUTURE WAS BROKEN. DETAILS ARE BEING CONFIRMED. 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 20788975 ↗
• MalfunctionNov 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING CLOSING THE HEAD, IT WAS TRIED TO SUTURE AND THEN LIGATE, BUT THE SUTURE WAS BROKEN. DETAILS ARE BEING CONFIRMED. 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 20788814 ↗
• MalfunctionNov 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING CLOSING THE HEAD, IT WAS TRIED TO SUTURE AND THEN LIGATE, BUT THE SUTURE WAS BROKEN. DETAILS ARE BEING CONFIRMED. 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 20788282 ↗
• MalfunctionOct 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17946898 ↗
• MalfunctionMay 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17006344 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY PROCEDURE ON (B)(6)2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THE NEEDLE TIP HAD BEEN BROKEN WHEN IT WAS TAKEN OUT FROM THE TRAY, AND THEREFORE THE PRODUCT WAS NOT USED. THE NEEDLE TIP DID NOT FALL INTO THE OPERATIVE FIELD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629639 ↗
• MalfunctionNov 7, 2021Break; Break

  IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE NEEDLE WAS BROKEN. NO BROKEN PIECES FELL INTO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING USE ON THE PATIENT THE NEEDLE WAS BROKEN. NO BROKEN PIECES FELL INTO THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760817 ↗
• MalfunctionSep 14, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12469402 ↗
• MalfunctionApr 19, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THE NEEDLE WAS DETACHED FROM THE SUTURE EASIER. 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 11685946 ↗
• MalfunctionFeb 19, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BRAIN TUMOR SURGERY ON (B)(6) 2021, AND SUTURE WAS USED. DURING INTERRUPTED SUTURING, THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY WHEN TRYING TO SUTURE, SO ANOTHER PACKAGE WAS USED. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11350167 ↗
• MalfunctionNov 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10908734 ↗
• MalfunctionNov 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10908625 ↗
• MalfunctionApr 6, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING INTERRUPTED SUTURING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9929228 ↗
• MalfunctionApr 24, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OSTEOTOMY ON (B)(6) 2019 AND SUTURE WAS USED. IT WAS FOUND THAT THE NEEDLE TIP HAD BEEN BROKEN WHEN HOLDING THE NEEDLE BY NEEDLE-HOLDER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546740 ↗

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