Coated VICRYL VCP452H (UDI 10705031053359)Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10705031053359), received between Feb 14, 2018 and Sep 25, 2026 — classified as 4 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Material Separation” (41 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 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898691 ↗
• MalfunctionSep 25, 2026Break; Material Separation

  It was reported that an animal underwent a cat oophorectomy procedure on an unknown date and suture was used. The problem affected 16 wires of the box. When a veterinarian pierces the skin by holding the needle with his usual needle holder, the needle breaks in half or pulled off from the thread at the second passage of the skin. The surgeries could be performed using another wire from the same box without affecting the animals to date. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898521 ↗
• MalfunctionJul 6, 2026Break

  IT WAS REPORTED THAT A CAT UNDERWENT A SURGICAL PROCEDURE ON OOPHORECTOMY ON (B)(6) 2026 AND SUTURE WAS USED FOR FLANK WOUND CLOSURE. THE CAT DID NOT HAVE A DRESSING OR AN ELIZABETHAN COLLAR POSTOPERATIVELY. THE CAT WAS RECHECKED 24 HOURS AFTER SKIN CLOSURE FOR WOUND DEHISCENCE. THE SUTURE USED FOR THE SUBCUTANEOUS SUTURE HAD RUPTURED ALONG ITS LENGTH; THE INITIAL AND TERMINAL SUTURE KNOTS WERE PRESENT. THE SUTURE MATERIAL APPEARED WHITE, TACKY, AND STRETCHED, AS IF ALREADY PARTLY ABSORBED, DESPITE HAVING BEEN PLACED THE PREVIOUS DAY. THE WOUND WAS RE-SUTURED USING ANOTHER SUTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Wound Dehiscence

  MAUDE report 25725188 ↗
• MalfunctionFeb 27, 2026Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CAT OOPHORECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE VETERINARIAN FINISHED HIS INTRADERMAL OVERSPRAY, HE PULLED ON THE THREAD AND NEEDLE WITH HIS NEEDLE HOLDER HOLDING THE NEEDLE, WITHOUT EXERTING EXCESSIVE TENSION, AND THEN THE NEEDLE PULLED OFF. SURGERY COULD BE PERFORMED USING ANOTHER THREAD WITHOUT AFFECTING THE CAT TO DATE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475087 ↗
• MalfunctionFeb 9, 2026Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN OOPHORECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. CUTANEOUS SUTURE OF CYST EXCISION AND CAT OOPHORECTOMY OF THE FEMALE CAT. CYST EXCISION: DURING SKIN SUTURE, AFTER 2 OR 3 TISSUE PASSAGES AND WITHOUT EXERTING EXCESSIVE PRESSURE, THE NEEDLE GOT DETACHED FROM THE THREAD. OOPHORECTOMY: WHEN SUTURING THE ABDOMINAL WALL, AFTER 2 OR 3 TISSUE PASSAGES AND WITHOUT APPLYING EXCESSIVE PRESSURE, THE NEEDLE GOT DETACHED FROM THE THREAD. THIS ISSUE OCCURRED ON 2 SUTURES DURING THE SAME OOPHORECTOMY, THEN AGAIN ON 2 SUTURES DURING ANOTHER SAME OOPHORECTOMY. THE SURGERIES WERE COMPLETED BY USING ANOTHER DEVICE WITHOUT ANY INCIDENCE ON THE ANIMALS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291786 ↗
• MalfunctionFeb 9, 2026Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN OOPHORECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. CUTANEOUS SUTURE OF CYST EXCISION AND CAT OOPHORECTOMY OF THE FEMALE CAT. CYST EXCISION: DURING SKIN SUTURE, AFTER 2 OR 3 TISSUE PASSAGES AND WITHOUT EXERTING EXCESSIVE PRESSURE, THE NEEDLE GOT DETACHED FROM THE THREAD. OOPHORECTOMY: WHEN SUTURING THE ABDOMINAL WALL, AFTER 2 OR 3 TISSUE PASSAGES AND WITHOUT APPLYING EXCESSIVE PRESSURE, THE NEEDLE GOT DETACHED FROM THE THREAD. THIS ISSUE OCCURRED ON 2 SUTURES DURING THE SAME OOPHORECTOMY, THEN AGAIN ON 2 SUTURES DURING ANOTHER SAME OOPHORECTOMY. THE SURGERIES WERE COMPLETED BY USING ANOTHER DEVICE WITHOUT ANY INCIDENCE ON THE ANIMALS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291783 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A CAT UNDERWENT AN OOPHORECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AT THE EXTRACTION FROM THE SHUTTLE, THE NEEDLE PULLED OFF THE THREAD. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE WITHOUT ANY INCIDENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888550 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A CAT UNDERWENT AN OOPHORECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AT THE EXTRACTION FROM THE SHUTTLE, THE NEEDLE PULLED OFF THE THREAD. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE WITHOUT ANY INCIDENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888548 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A CAT UNDERWENT AN OOPHORECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AT THE EXTRACTION FROM THE SHUTTLE, THE NEEDLE PULLED OFF THE THREAD. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE WITHOUT ANY INCIDENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888546 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A CAT UNDERWENT AN OOPHORECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AT THE EXTRACTION FROM THE SHUTTLE, THE NEEDLE PULLED OFF THE THREAD. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE WITHOUT ANY INCIDENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888545 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A CAT UNDERWENT AN OOPHORECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AT THE EXTRACTION FROM THE SHUTTLE, THE NEEDLE PULLED OFF THE THREAD. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE WITHOUT ANY INCIDENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888544 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A CAT UNDERWENT AN OOPHORECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AT THE EXTRACTION FROM THE SHUTTLE, THE NEEDLE PULLED OFF THE THREAD. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE WITHOUT ANY INCIDENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888543 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A CAT UNDERWENT AN OOPHORECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AT THE EXTRACTION FROM THE SHUTTLE, THE NEEDLE PULLED OFF THE THREAD. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE WITHOUT ANY INCIDENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888542 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A CAT UNDERWENT AN OOPHORECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AT THE EXTRACTION FROM THE SHUTTLE, THE NEEDLE PULLED OFF THE THREAD. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE WITHOUT ANY INCIDENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888541 ↗
• MalfunctionDec 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A CAT UNDERWENT AN OOPHORECTOMY (BILATERAL) PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE VETERINARIAN PERFORMED THE LIGATIONS OF THE 2 OVARIES WITH THE POTENTIALLY DEFECTIVE WIRE. WHEN THE VETERINARIAN WANTED TO DO OVER-JET MUSCLE, WITHOUT EXERTING EXCESSIVE TENSION, HE NOTICED THAT THE THREAD HELD VERY LITTLE TO THE NEEDLE. THE VETERINARIAN THEREFORE NO LONGER USED THE WIRE FOR SURGERY. THE SURGERY COULD BE PERFORMED USING ANOTHER THREAD FROM THE SAME BOX WITHOUT AFFECTING THE CAT TO DATE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850021 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING SURGERY, THE THREAD BECAME DETACHED FROM THE NEEDLE. (PULLED OFF). THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647411 ↗
• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A POST-SURGERY HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DISINTEGRATION WITH 2 SUTURES POST-SURGERY HERNIA. THE CAT WAS REVIEWED FOR A HERNIA IN THE ABDOMINAL INCISIONAL WOUND. THE OVERJET OF THE ABDOMINAL WALL HAD RUPTURED IN THE LENGTH OF THE WIRE, THE POINTS BEING INTACT. THE WOUND WAS SURGICALLY REPEATED WITH A SUTURE FROM THE SAME BATCH. SCAR EVOLUTION IS UNDERWAY. NO ADDITIONAL INFORMATION WAS REQUESTED AT THIS TIME.

  Patient problems: Wound Dehiscence

  MAUDE report 23581940 ↗
• MalfunctionNov 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CAT OOPHORECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. DISINTEGRATION WITH 2 SUTURES DURING THE SAME SURGERY DURING CAT OOPHORECTOMY, THE VETERINARIAN USES SUTURE FOR ABDOMINAL WALL LIGATION AND OVERLAY AND SKIN OVERLAY. CATS WEAR A COLLAR POST-OPERATIVELY. WHEN SUTURING THE ABDOMINAL WALL, AFTER 1 OR 2 TISSUE PASSAGES AND WITHOUT EXERTING EXCESSIVE PRESSURE, THE NEEDLE BECAME DETACHED FROM THE THREAD. THIS PROBLEM OCCURRED ON 2 SUTURES DURING THE SAME SURGERY. THE SURGERY COULD BE COMPLETED, USING A NEW THREAD, WITHOUT AFFECTING THE ANIMAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581863 ↗
• MalfunctionNov 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CAT OOPHORECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. DISINTEGRATION WITH 2 SUTURES DURING THE SAME SURGERY DURING CAT OOPHORECTOMY, THE VETERINARIAN USES SUTURE FOR ABDOMINAL WALL LIGATION AND OVERLAY AND SKIN OVERLAY. CATS WEAR A COLLAR POST-OPERATIVELY. WHEN SUTURING THE ABDOMINAL WALL, AFTER 1 OR 2 TISSUE PASSAGES AND WITHOUT EXERTING EXCESSIVE PRESSURE, THE NEEDLE BECAME DETACHED FROM THE THREAD. THIS PROBLEM OCCURRED ON 2 SUTURES DURING THE SAME SURGERY. THE SURGERY COULD BE COMPLETED, USING A NEW THREAD, WITHOUT AFFECTING THE ANIMAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581861 ↗
• MalfunctionOct 22, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN YOU OPEN EACH PACKAGE, THERE'S ALREADY A KINK WHERE THE NEEDLE AND THREAD CONNECT. THIS CAUSES THE THREAD TO BREAK OFF THE NEEDLE MULTIPLE TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356541 ↗
• MalfunctionOct 22, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN YOU OPEN EACH PACKAGE, THERE'S ALREADY A KINK WHERE THE NEEDLE AND THREAD CONNECT. THIS CAUSES THE THREAD TO BREAK OFF THE NEEDLE MULTIPLE TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356530 ↗
• MalfunctionOct 22, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN YOU OPEN EACH PACKAGE, THERE'S ALREADY A KINK WHERE THE NEEDLE AND THREAD CONNECT. THIS CAUSES THE THREAD TO BREAK OFF THE NEEDLE MULTIPLE TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356528 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, EARLY LOOSENING (AFTER 1-3 BITES) OF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292917 ↗
• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE VETERINARIAN REPORTS A DOUBT ABOUT THE RESISTANCE OF VICRYL 3-0 SUTURES, WHICH SHE HAS BEEN USING FOR 2 TO 3 MONTHS. IT INDICATES AN APPARENT ABSENCE OF RESISTANCE DURING USE. TWO BOXES OF THE SAME LOT ARE STILL AVAILABLE AT THE CLINIC. THE VETERINARIAN STATES THAT THERE HAS BEEN NO CLINICAL IMPACT TO DATE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955024 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE THREAD IS MUCH MORE BRITTLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22868587 ↗

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