Coated VICRYL VCP958HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031056213), received between May 9, 2024 and Jun 22, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE JUST BELOW THE SWAGE OF THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25586111 ↗
• MalfunctionJun 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A PROCEDURE, THREE SUTURES BROKE INTRAOPERATIVELY JUST BELOW THE SWAGE. THE SUTURES BEHAVED LIKE A POP-OFF AND BROKE AT THE TOP WHEN THE SURGEON PASSED THEM THROUGH THE TISSUE DURING APPROXIMATION AT THE END OF THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461652 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING A C-SECTION CASE, THE SUTURE NEEDLE SNAPPED WHILE GOING THROUGH THE SUBCUTICULAR LAYER. THE BROKEN NEEDLE WAS FOUND IN PATIENT'S BODY. THEY DID NOT USE AN X-RAY BUT THEY WERE ABLE TO RETRIEVE THE BROKEN NEEDLE. THERE WAS NO PATIENT CONSEQUENCES. DEVICE WILL BE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240428 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP BY THE SURGICAL TECH IN THE ROOM, THAT THERE WERE TWO SUTURES USED THAT BOTH SNAPPED. NOT THE NEEDLE, BUT THE ACTUAL SUTURE. THE NEEDLE WAS BROKEN DURING A ROUTINE SUTURING OF A PATIENT WITH A HIGHER BMI. SHE NOTED THAT THEIR NEEDLE GRASPERS ARE FUNCTIONING CORRECTLY AND IS UNSURE OF THE CAUSE OF THE BREAKAGE. PREVIOUSLY REPORTED A SEPARATE PI FOR THE PRODUCT CODE AT SAME FACILITY WHERE NEEDLE BROKE. THIS REPORT SHOULD BE LINKED TO (B)(4).. THE DEVICE WAS NOT RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095304 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP BY THE SURGICAL TECH IN THE ROOM, THAT THERE WERE TWO SUTURES USED THAT BOTH SNAPPED. NOT THE NEEDLE, BUT THE ACTUAL SUTURE. THE NEEDLE WAS BROKEN DURING A ROUTINE SUTURING OF A PATIENT WITH A HIGHER BMI. SHE NOTED THAT THEIR NEEDLE GRASPERS ARE FUNCTIONING CORRECTLY AND IS UNSURE OF THE CAUSE OF THE BREAKAGE. PREVIOUSLY REPORTED A SEPARATE PI FOR THE PRODUCT CODE AT SAME FACILITY WHERE NEEDLE BROKE. THIS REPORT SHOULD BE LINKED TO (B)(4). THE DEVICE WAS NOT RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095303 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT, WHEN THE SURGEON WENT TO PICK UP THE SUTURE THE TIP OF THE NEEDLE FLEW OFFHAND. THEY TRIED TO FIND THE NEEDLE AND DID AN X-RAY, BUT IT WAS NOT FOUND IN THE PATIENT OR IN THE OR, CAUSING SOME DELAY TO THE CASE. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS NOT FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351260 ↗
• MalfunctionMay 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE OF THE SUTURE JUST CAME OFF. IT GOT LODGED IN THE UTERUS, BUT THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLE AND GOT ANOTHER SUTURE TO PROCEED WITH THE CASE WITHOUT PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280922 ↗

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