Coated VICRYL VCP493GRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705031053656), received between Jan 11, 2021 and May 11, 2026 — classified as 2 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Material Separation” (31 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE FIRST STITCH IS SEWN, THE NEEDLE AND THREAD SEPARATE AS THEY PASS THROUGH THE TISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136854 ↗
• MalfunctionMay 11, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE FIRST STITCH IS SEWN, THE NEEDLE AND THREAD SEPARATE AS THEY PASS THROUGH THE TISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136756 ↗
• MalfunctionFeb 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY HAD SEVERAL COMPLAINTS ABOUT THE NEEDLE POPPING OFF THE SUTURE. THEY DO NOT HAVE ANY PACKAGING FROM ANY OF THE DEFECTIVE ONES. NO ADVERSE EVENT WAS REPORTED. DEVICE AVAILABILITY: UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303789 ↗
• MalfunctionFeb 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY HAD SEVERAL COMPLAINTS ABOUT THE NEEDLE POPPING OFF THE SUTURE. THEY DO NOT HAVE ANY PACKAGING FROM ANY OF THE DEFECTIVE ONES. NO ADVERSE EVENT WAS REPORTED. DEVICE AVAILABILITY: UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303780 ↗
• MalfunctionFeb 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY HAD SEVERAL COMPLAINTS ABOUT THE NEEDLE POPPING OFF THE SUTURE. THEY DO NOT HAVE ANY PACKAGING FROM ANY OF THE DEFECTIVE ONES. NO ADVERSE EVENT WAS REPORTED. DEVICE AVAILABILITY: UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303756 ↗
• MalfunctionFeb 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY HAD SEVERAL COMPLAINTS ABOUT THE NEEDLE POPPING OFF THE SUTURE. THEY DO NOT HAVE ANY PACKAGING FROM ANY OF THE DEFECTIVE ONES. NO ADVERSE EVENT WAS REPORTED. DEVICE AVAILABILITY: UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303750 ↗
• MalfunctionFeb 9, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY HAD SEVERAL COMPLAINTS ABOUT THE NEEDLE POPPING OFF THE SUTURE. THEY DO NOT HAVE ANY PACKAGING FROM ANY OF THE DEFECTIVE ONES. NO ADVERSE EVENT WAS REPORTED. DEVICE AVAILABILITY: UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292150 ↗
• MalfunctionFeb 9, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY HAD SEVERAL COMPLAINTS ABOUT THE NEEDLE POPPING OFF THE SUTURE. THEY DO NOT HAVE ANY PACKAGING FROM ANY OF THE DEFECTIVE ONES. NO ADVERSE EVENT WAS REPORTED. DEVICE AVAILABILITY: UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292141 ↗
• MalfunctionFeb 9, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY HAD SEVERAL COMPLAINTS ABOUT THE NEEDLE POPPING OFF THE SUTURE. THEY DO NOT HAVE ANY PACKAGING FROM ANY OF THE DEFECTIVE ONES. NO ADVERSE EVENT WAS REPORTED. DEVICE AVAILABILITY: UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292138 ↗
• MalfunctionFeb 9, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY HAD SEVERAL COMPLAINTS ABOUT THE NEEDLE POPPING OFF THE SUTURE. THEY DO NOT HAVE ANY PACKAGING FROM ANY OF THE DEFECTIVE ONES. NO ADVERSE EVENT WAS REPORTED. DEVICE AVAILABILITY: UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292133 ↗
• MalfunctionNov 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WAS ALERTED BY MEH STORE PERSONNEL <STORE PERSONNEL NAME> THAT SUTURE DISLODGED AT SWAGE DESPITE SURGEON PULLING WITH GENTLE FORCE. ADDITIONAL PIECE WAS OPENED TO CONTINUE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607763 ↗
• MalfunctionJun 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. YESTERDAY THEY HAD ANOTHER SURGICAL CASE, AND THIS TIME THEY WENT THROUGH 6 PACKS BEFORE THEIR SURGEON REFUSED TO USE ANY MORE OF THE SUTURES AS THE NEEDLE KEPT BREAKING AWAY DURING USE. THEY ENDED UP USING A PACK OF SUTURES FROM ANOTHER BRAND TO FINISH THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140547 ↗
• MalfunctionJun 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. YESTERDAY THEY HAD ANOTHER SURGICAL CASE, AND THIS TIME THEY WENT THROUGH 6 PACKS BEFORE THEIR SURGEON REFUSED TO USE ANY MORE OF THE SUTURES AS THE NEEDLE KEPT BREAKING AWAY DURING USE. THEY ENDED UP USING A PACK OF SUTURES FROM ANOTHER BRAND TO FINISH THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140545 ↗
• MalfunctionJun 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. YESTERDAY THEY HAD ANOTHER SURGICAL CASE, AND THIS TIME THEY WENT THROUGH 6 PACKS BEFORE THEIR SURGEON REFUSED TO USE ANY MORE OF THE SUTURES AS THE NEEDLE KEPT BREAKING AWAY DURING USE. THEY ENDED UP USING A PACK OF SUTURES FROM ANOTHER BRAND TO FINISH THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140543 ↗
• MalfunctionJun 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. YESTERDAY THEY HAD ANOTHER SURGICAL CASE, AND THIS TIME THEY WENT THROUGH 6 PACKS BEFORE THEIR SURGEON REFUSED TO USE ANY MORE OF THE SUTURES AS THE NEEDLE KEPT BREAKING AWAY DURING USE. THEY ENDED UP USING A PACK OF SUTURES FROM ANOTHER BRAND TO FINISH THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140538 ↗
• MalfunctionJun 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. YESTERDAY THEY HAD ANOTHER SURGICAL CASE, AND THIS TIME THEY WENT THROUGH 6 PACKS BEFORE THEIR SURGEON REFUSED TO USE ANY MORE OF THE SUTURES AS THE NEEDLE KEPT BREAKING AWAY DURING USE. THEY ENDED UP USING A PACK OF SUTURES FROM ANOTHER BRAND TO FINISH THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140452 ↗
• MalfunctionJun 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. YESTERDAY THEY HAD ANOTHER SURGICAL CASE, AND THIS TIME THEY WENT THROUGH 6 PACKS BEFORE THEIR SURGEON REFUSED TO USE ANY MORE OF THE SUTURES AS THE NEEDLE KEPT BREAKING AWAY DURING USE. THEY ENDED UP USING A PACK OF SUTURES FROM ANOTHER BRAND TO FINISH THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140379 ↗
• MalfunctionJun 4, 2025Material 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 KEEPS DETACHING FROM THE THREAD AFTER THE 2ND ¿ 3RD PASS WHEN SUTURING THE SOFT TISSUE. LAST WEEK THEIR SURGEON WENT TO USE A PACK AND THE NEEDLE DETACHED AFTER THE FIRST SUTURE WAS PLACED. THEY HAD TO OPEN ANOTHER 3 PACKS BEFORE THEY WERE ABLE FINISH THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140310 ↗
• MalfunctionJun 4, 2025Material 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 KEEPS DETACHING FROM THE THREAD AFTER THE 2ND ¿ 3RD PASS WHEN SUTURING THE SOFT TISSUE. LAST WEEK THEIR SURGEON WENT TO USE A PACK AND THE NEEDLE DETACHED AFTER THE FIRST SUTURE WAS PLACED. THEY HAD TO OPEN ANOTHER 3 PACKS BEFORE THEY WERE ABLE FINISH THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140304 ↗
• MalfunctionJun 4, 2025Material 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 KEEPS DETACHING FROM THE THREAD AFTER THE 2ND ¿ 3RD PASS WHEN SUTURING THE SOFT TISSUE. LAST WEEK THEIR SURGEON WENT TO USE A PACK AND THE NEEDLE DETACHED AFTER THE FIRST SUTURE WAS PLACED. THEY HAD TO OPEN ANOTHER 3 PACKS BEFORE THEY WERE ABLE FINISH THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140303 ↗
• MalfunctionJun 4, 2025Material 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 KEEPS DETACHING FROM THE THREAD AFTER THE 2ND ¿ 3RD PASS WHEN SUTURING THE SOFT TISSUE. LAST WEEK THEIR SURGEON WENT TO USE A PACK AND THE NEEDLE DETACHED AFTER THE FIRST SUTURE WAS PLACED. THEY HAD TO OPEN ANOTHER 3 PACKS BEFORE THEY WERE ABLE FINISH THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140300 ↗
• MalfunctionMar 20, 2025Material 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 SEVERAL SURGEONS COMPLAINING OF NEEDLE POP OFF AND A PROCEDURE TODAY WHERE SIX DIFFERENT NEEDLE POP OFFS DURING THE CASE. UNKNOWN AS TO HOW THE PROCEDURES WERE COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. UNKNOWN QUANTITY OF STERILE SAMPLES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651425 ↗
• MalfunctionMar 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT SEVERAL SURGEONS COMPLAINING OF NEEDLE POP OFF AND A PROCEDURE TODAY WHERE SIX DIFFERENT NEEDLE POP OFFS DURING THE CASE. UNKNOWN AS TO HOW THE PROCEDURES WERE COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. UNKNOWN QUANTITY OF STERILE SAMPLES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651424 ↗
• MalfunctionMar 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT SEVERAL SURGEONS COMPLAINING OF NEEDLE POP OFF AND A PROCEDURE TODAY WHERE SIX DIFFERENT NEEDLE POP OFFS DURING THE CASE. UNKNOWN AS TO HOW THE PROCEDURES WERE COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. UNKNOWN QUANTITY OF STERILE SAMPLES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651420 ↗
• MalfunctionMar 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT SEVERAL SURGEONS COMPLAINING OF NEEDLE POP OFF AND A PROCEDURE TODAY WHERE SIX DIFFERENT NEEDLE POP OFFS DURING THE CASE. UNKNOWN AS TO HOW THE PROCEDURES WERE COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. UNKNOWN QUANTITY OF STERILE SAMPLES RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651419 ↗

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