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
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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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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