VICRYL RAPIDE VR490Recalls & reported problems
Ethicon, LLC · Undyed Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031134591), received between May 23, 2019 and Dec 29, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
- Material Separation3
Patient problems
- Insufficient Information3
- Wound Dehiscence3
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN A DENTAL PROCEDURE WITH EXTRACTION ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER HEALTHCARE PROFESSIONAL THAT SUTURE BREAKING, HAVING MULTIPLE PET REACTIONS. PET 3: PRESENTED FOR A DENTAL PROCEDURE W/EXTRACTION ON (B)(6) 2025. AS RECHECK, SITE 409 HAD OPENED UP AND HAD FOOD MATERIAL IN SOCKET WITH BAD ODOR. TREATED WITH ANTIBIOTICS AND FLUSHING. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information; Wound Dehiscence
MAUDE report 23905980 ↗MalfunctionDec 29, 2025Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT A DENTAL PROCEDURE WITH EXTRACTIONS ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER HEALTHCARE PROFESSIONAL THAT SUTURE LINE BREAKING, HAVING ISSUES WITH MULTIPLE PETS. PET TWO: 2. PRESENTED FOR DENTAL PROCEDURE WITH EXTRACTIONS ON (B)(6) 2025. EXTRACTION SITE 308 OPENED AT RECHECK ON (B)(6) 2025. TREATED WITH ANTIBIOTICS AND FLUSHING. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information; Wound Dehiscence
MAUDE report 23905953 ↗MalfunctionDec 29, 2025Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT A DENTAL PROCEDURE WITH EXTRACTIONS ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER HEALTHCARE PROFESSIONAL THAT SUTURE IS BREAKING, MULTIPLE PETS AFFECTED. PET ONE: 1. PRESENTED FOR A DENTAL PROCEDURE WITH EXTRACTIONS ON (B)(6) 2025. EXTRACTION SITE 104 OPENED AND RECHECKED ON (B)(6) 2025. TREATED WITH ANTIBIOTICS AND FLUSHING. RECHECKED (B)(6) 2025, HEALED BUT DEPRESSED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information; Wound Dehiscence
MAUDE report 23905935 ↗MalfunctionNov 4, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE DOCTOR WAS SUTURING THE PATIENT'S WRIST WITH SUTURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. FOLLOWING THE DOCTOR'S ADVICE, A NEW NEEDLE WAS REPLACED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465668 ↗MalfunctionDec 11, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON WAS USING THE 5-0 COATED SUTURE P-1 CUTTING NEEDLE, 11MM. WHILE SUTURING, THE NEEDLE BROKE, LUCKILY IT WAS CLOSER TO THE STRAIGHTER SECTION BEFORE THE SUTURE STARTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20902096 ↗MalfunctionMay 28, 2019Material Separation; Material Separation
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE AT THE SWAGE. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8645385 ↗MalfunctionMay 23, 2019Material Separation; Material Separation
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING USE, THE NEEDLE POPPED OFF THE SUTURE AT THE SWAGE. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8639053 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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