Coated VICRYL VCP341H (UDI 10705031052512)Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10705031052512), received between Sep 17, 2019 and Sep 28, 2026 — classified as 2 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Material Separation” (28 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920070 ↗
• MalfunctionSep 28, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920062 ↗
• MalfunctionSep 28, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920060 ↗
• MalfunctionAug 13, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50237856 ↗
• MalfunctionAug 13, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50237853 ↗
• MalfunctionJun 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. WHILST SURGEON WAS PUTTING IN A HAEMOSTATIC STITCH CURVING THROUGH THE UTERUS THE NEEDLE SNAPPED IN HALF THE SURGEON WAS HOLDING ONTO THE TOP OF THE NEEDLE WITH THE FORCEPS SO THE NEEDLE WAS NOT LOST AT ANYTIME. NEW SUTURE USED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25666915 ↗
• MalfunctionMay 21, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE NEEDLES BECOME DETACHED FROM THREADS DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240650 ↗
• MalfunctionMay 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE NEEDLES BECOME DETACHED FROM THREADS DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148011 ↗
• MalfunctionMay 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE NEEDLES BECOME DETACHED FROM THREADS DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25147929 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EMERGENCY CESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING CLOSING OF THE SKIN, THE NEEDLE BROKE ACCIDENTALLY. THE GYNECOLOGIST ORDERED AN X-RAY OF THE ABDOMEN, WHERE NO REFERENCE DEVICE WAS OBSERVED. WOUND CLOSURE WAS CARRIED OUT. THE PATIENT WAS INFORMED OF WHAT HAPPENED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE CURRENT CONDITION OF THE PATIENT WAS REPORTED AS WELL, WITHOUT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933562 ↗
• InjuryApr 8, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SURGICAL PROCEDURE, WHILE USING THE NEEDLE, THE SUTURE DETACHED FROM THE NEEDLE, LEAVING THE NEEDLE EMBEDDED IN THE TISSUE. X RAYS WERE USED TO LOCATE THE RETAINED NEEDLE, RESULTING IN POTENTIALLY DANGEROUS INCISIONS TO THE UTERUS AND CARRYING A RISK OF HYSTERECTOMY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821222 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. TEN DAYS AFTER SURGERY, THE PATIENT HAS ABUNDANT DRAINAGE AND WOUND DEHISCENCE. IMAGING, LABORATORY STUDIES, AND CULTURES ARE PERFORMED. FISTULA AND SURGICAL SITE INFECTION ARE RULED OUT AS THE STUDIES ARE NEGATIVE. THE DOCTOR ATTRIBUTES THE ADVERSE EVENT TO AN ALLERGIC REACTION TO THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Wound Dehiscence

  MAUDE report 23480844 ↗
• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201724 ↗
• MalfunctionDec 13, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2024 AND SUTURE WAS USED. THE SURGEON COMPLAINED THAT THE THREAD FELT THINNER THAN A CALIBER 1. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929400 ↗
• MalfunctionDec 13, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2024 AND SUTURE WAS USED. THE SURGEON COMPLAINED THAT THE THREAD FELT THINNER THAN A CALIBER 1. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929290 ↗
• MalfunctionDec 13, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6)2024 AND SUTURE WAS USED. THE SURGEON COMPLAINED THAT THE THREAD FELT THINNER THAN A CALIBER 1. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929276 ↗
• MalfunctionDec 13, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2024 AND SUTURE WAS USED. THE SURGEON COMPLAINED THAT THE THREAD FELT THINNER THAN A CALIBER 1. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929130 ↗
• MalfunctionDec 13, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6)2024 AND SUTURE WAS USED. THE SURGEON COMPLAINED THAT THE THREAD FELT THINNER THAN A CALIBER 1. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929098 ↗
• MalfunctionDec 13, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2024 AND SUTURE WAS USED. THE SURGEON COMPLAINED THAT THE THREAD FELT THINNER THAN A CALIBER 1. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929097 ↗
• MalfunctionAug 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. AT THE TIME OF MAKING THE MUSCLES PLICATION, THE NEEDLE IS PULLED FROM THE THREAD, AND THE NEEDLE REMAINS IN THE CAVITY. HE STAYED BETWEEN FASCIA/MUSCLE. FORTUNATELY, A TIP OF THE NEEDLE WAS VISIBLE AND COULD BE REMOVED. BUT THE THREAD CAME OUT WITHOUT A NEEDLE, PUTTING THE PATIENT AT RISK. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026860 ↗
• MalfunctionJul 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BREAKS OFF THE THREAD. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840109 ↗
• MalfunctionJul 26, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, ONE OF THE SUTURE BOXES DELIVERED TO OUR BUSINESS PARTNER WAS CONTAMINATED IN SECONDARY PACKAGING WITH A DEAD INSECT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19839174 ↗
• MalfunctionJul 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE IS DETACHED FROM THE THREAD. THREE SUTURES WERE USED AND IN THREE THE SAME HAPPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19807525 ↗
• MalfunctionJul 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE IS DETACHED FROM THE THREAD. THREE SUTURES WERE USED AND IN THREE THE SAME HAPPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19807515 ↗
• MalfunctionJul 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE IS DETACHED FROM THE THREAD. THREE SUTURES WERE USED AND IN THREE THE SAME HAPPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19807509 ↗

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