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Coated VICRYL VCP452H (UDI 10705031149977)Recalls & reported problems

Ethicon Inc. · Antibacterial Violet Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant

All models of Coated VICRYL (114)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
14
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031149977), received between Jun 20, 2025 and Sep 1, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (12 reports).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 4 reportsAug 2025: 3 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 3 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 2 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Separation12
  • Break2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions13
  • Wound Dehiscence1

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 1, 2026Material Separation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50545502 ↗
  • MalfunctionSep 1, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50541681 ↗
  • MalfunctionMar 9, 2026Material Separation

    IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE A SUTURE WAS USED. NEEDLE COMING APART FROM SUTURE, BARELY HOLDING ON. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24546482 ↗
  • MalfunctionMar 4, 2026Material Separation

    IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN OOPHORECTOMIES PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS LOOSENING WITH WHEN SUTURING THE ABDOMINAL WALL, AFTER 2 OR 3 TISSUE PASSAGES AND WITHOUT EXERTING EXCESSIVE PRESSURE, THE NEEDLE BECAME DETACHED FROM THE THREAD. THIS PROBLEM OCCURRED ON 3 SUTURES, ON OOPHORECTOMIES OF DIFFERENT CATS. THE SURGERIES COULD BE COMPLETED, USING A NEW WIRE, WITHOUT AFFECTING THE ANIMALS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24513385 ↗
  • MalfunctionMar 3, 2026Material Separation

    IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN OOPHORECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS LOOSENING WITH WHEN SUTURING THE ABDOMINAL WALL, AFTER 2 OR 3 TISSUE PASSAGES AND WITHOUT EXERTING EXCESSIVE PRESSURE, THE NEEDLE BECAME DETACHED FROM THE THREAD. THIS PROBLEM OCCURRED ON 3 SUTURES, ON OOPHORECTOMIES OF DIFFERENT CATS. THE SURGERIES COULD BE COMPLETED, USING A NEW WIRE, WITHOUT AFFECTING THE ANIMALS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24496209 ↗
  • MalfunctionSep 10, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON 11-AUG2025 AND SUTURE WAS USED. THE SPECIALIST VETERINARY ASSISTANT WISHES TO REPORT A QUALITY DEFECT CONCERNING VICRYL PLUS, WHOSE THREAD BREAKS AT THE NEEDLE. SHE INDICATES THAT THIS PROBLEM HAS OCCURRED SEVERAL TIMES, DURING DIFFERENT TYPES OF SURGERIES. NO IMPACT ON ANIMALS WAS FOUND. IT CLARIFIES THAT THE DEFECT DOES NOT AFFECT ALL POCKETS IN THE LOT. TO DATE, ABOUT HALF OF THE BOX REMAINS AVAILABLE AT THE CLINIC. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23016217 ↗
  • MalfunctionAug 6, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN EXCISION OF MASTOCYTOMA PROCEDURE IN A DOG ON (B)(6) 2025 AND SUTURE WAS USED. WHEN THE VETERINARIAN SUTURED THE MUSCULAR PLANE, THE NEEDLE LOOSENED FROM THE THREAD. THE VETERINARIAN TOOK ANOTHER THREAD FROM THE SAME BOX WHOSE NEEDLE ALSO LOOSENED DURING THE SUTURE OF THE MUSCULAR PLANE. THE SURGERIES WERE ABLE TO BE PERFORMED USING OTHER THREADS WITH NO IMPACT ON THE ANIMALS TO DATE. THERE WERE NO QUALITY DEFECTS OR NON-CONFORMITIES NOTED WITH THE 2 SUTURES BEFORE USE AND DURING POSTOPERATIVE EXAMINATIONS. NO REOPERATION TOOK PLACE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22726499 ↗
  • MalfunctionAug 6, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN EXCISION OF MASTOCYTOMA PROCEDURE IN A DOG ON (B)(6) 2025 AND SUTURE WAS USED. WHEN THE VETERINARIAN SUTURED THE MUSCULAR PLANE, THE NEEDLE LOOSENED FROM THE THREAD. THE VETERINARIAN TOOK ANOTHER THREAD FROM THE SAME BOX WHOSE NEEDLE ALSO LOOSENED DURING THE SUTURE OF THE MUSCULAR PLANE. THE SURGERIES WERE ABLE TO BE PERFORMED USING OTHER THREADS WITH NO IMPACT ON THE ANIMALS TO DATE. THERE WERE NO QUALITY DEFECTS OR NON-CONFORMITIES NOTED WITH THE 2 SUTURES BEFORE USE AND DURING POSTOPERATIVE EXAMINATIONS. NO REOPERATION TOOK PLACE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22726487 ↗
  • MalfunctionAug 6, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CAT OOPHORECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. WHEN THE VETERINARIAN SUTURED THE SUBCUTANEOUS PLANE, THE NEEDLE LOOSENED FROM THE THREAD. THERE WERE NO QUALITY DEFECTS OR NON-CONFORMITIES NOTED WITH THE SUTURE BEFORE USE AND DURING POSTOPERATIVE EXAMINATIONS. NO REOPERATION TOOK PLACE. THE SURGERIES WERE ABLE TO BE PERFORMED USING OTHER THREADS WITH NO IMPACT ON THE ANIMALS TO DATE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22726471 ↗
  • MalfunctionJul 25, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT AN ANIMAL UNDERWENT A OVARIECTOMY OF A FEMALE CAT PROCEDURE IN JUNE 2025 AND SUTURE WAS USED. IT WAS REPORTED UNTHREADING. DURING THE SUTURING OF THE ABDOMINAL WALL, AFTER 1 OR 2 TISSUE PASSES AND WITHOUT APPLYING EXCESSIVE PRESSURE, THE NEEDLE BECAME DETACHED FROM THE THREAD. THIS ISSUE OCCURRED WITH 4 VICRYL PLUS VCP452H. THE SURGERIES WERE ABLE TO BE COMPLETED USING A NEW THREAD, WITHOUT ANY IMPACT ON THE ANIMALS. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22621188 ↗
  • MalfunctionJul 25, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT AN ANIMAL UNDERWENT A OVARIECTOMY OF A FEMALE CAT PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED UNTHREADING. DURING THE SUTURING OF THE ABDOMINAL WALL, AFTER 1 OR 2 TISSUE PASSES AND WITHOUT APPLYING EXCESSIVE PRESSURE, THE NEEDLE BECAME DETACHED FROM THE THREAD. THIS ISSUE OCCURRED WITH 4 VICRYL PLUS VCP452H. THE SURGERIES WERE ABLE TO BE COMPLETED USING A NEW THREAD, WITHOUT ANY IMPACT ON THE ANIMALS. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22610971 ↗
  • MalfunctionJul 25, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT AN ANIMAL UNDERWENT A OVARIECTOMY OF A FEMALE CAT PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED UNTHREADING. DURING THE SUTURING OF THE ABDOMINAL WALL, AFTER 1 OR 2 TISSUE PASSES AND WITHOUT APPLYING EXCESSIVE PRESSURE, THE NEEDLE BECAME DETACHED FROM THE THREAD. THIS ISSUE OCCURRED WITH 4 VICRYL PLUS VCP452H. THE SURGERIES WERE ABLE TO BE COMPLETED USING A NEW THREAD, WITHOUT ANY IMPACT ON THE ANIMALS. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22610957 ↗
  • MalfunctionJul 25, 2025Material Separation; Material Separation

    IT WAS REPORTED THAT AN ANIMAL UNDERWENT A OVARIECTOMY OF A FEMALE CAT PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED UNTHREADING. DURING THE SUTURING OF THE ABDOMINAL WALL, AFTER 1 OR 2 TISSUE PASSES AND WITHOUT APPLYING EXCESSIVE PRESSURE, THE NEEDLE BECAME DETACHED FROM THE THREAD. THIS ISSUE OCCURRED WITH 4 VICRYL PLUS VCP452H. THE SURGERIES WERE ABLE TO BE COMPLETED USING A NEW THREAD, WITHOUT ANY IMPACT ON THE ANIMALS. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22610948 ↗
  • MalfunctionJun 20, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED AN ANIMAL UNDERWENT AN OOPHORECTOMY VETERINARY PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. POST-OP, PROBLEM: ABDOMINAL INCISIONAL WOUND DEHISCENCES WITH EVENTRATION DURING OOPHORECTOMY, THE VETERINARIAN USES VICRYL PLUS VCP452H FOR OVARIAN PEDICLE LIGATION, MUSCLE WALL OVERSHOT AND SKIN OVERSHOT. CATS AND RABBITS WEAR A COLLAR POST-OPERATIVELY. DURING (B)(6) 2025, A CAT AND A RABBIT WERE REVIEWED 24H TO 48H DAYS AFTER OOPHORECTOMY (EXACT DATES UNKNOWN), FOR ABDOMINAL INCISIONAL WOUND DEHISCENCE WITH EVENTRATION. IN BOTH CASES, THE VICRYL PLUS VCP452H OF THE ABDOMINAL WALL OVERJET HAD RUPTURED IN LENGTH, WITH THE OVERJET START AND END POINTS PRESENT. THE DEHISCENCES WERE SURGICALLY REPEATED, USING ANOTHER VICRYL (EXACT REFERENCE NOT KNOWN); THE SCAR EVOLUTION WAS THEN NORMAL FOR THE RABBIT; IT IS ONGOING FOR THE CAT. THE VETERINARIAN SUSPECTS AN ABNORMALITY ON A LOT OF THREADS OF VICRYL PLUS VCP452H. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Wound Dehiscence

    MAUDE report 22298686 ↗

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