VICRYL RAPIDE VR494Recalls & reported problems
Ethicon, LLC · Undyed Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant
Quick summary
This Ethicon Vicryl Rapide absorbable surgical suture is used to close wounds. The 34 reports mostly describe the suture breaking, separating into pieces, or coming apart from its needle during surgery, with 2 injuries and no deaths. One recall, started in August 2017 over suture damage found in testing, has been terminated.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10705031134683), received between Apr 3, 2018 and Jul 30, 2026 — classified as 2 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Break” (19 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Aug 17, 2017Terminated
On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture that were distributed to the field. During finished goods testing, a suture damage was identified on a lot of VICRYL RAPIDETM Suture. During the course of the subsequent investigation, the suture also failed knot tensile strength testing.
Z-0693-2018 · Root cause: Equipment maintenance · FDA record ↗
Most reported problems
Device problems
- Break19
- Material Separation16
- Material Twisted/Bent3
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Foreign Body In Patient1
- Not Applicable1
- Wound Dehiscence1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50085258 ↗MalfunctionJul 28, 2026Material Separation; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060742 ↗MalfunctionJul 28, 2026Material Separation; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060741 ↗MalfunctionJul 28, 2026Material Separation; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060734 ↗MalfunctionMay 8, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL PER HEALTHCARE PROFESSIONAL THE IS COMING UNFLAGGED FROM THE NEEDLES AND UNATTACHED. SITE HAVE HAD 3 SEPARATE PACKS FROM THIS BOX. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25128640 ↗MalfunctionMay 8, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL PER HEALTHCARE PROFESSIONAL THE IS COMING UNFLAGGED FROM THE NEEDLES AND UNATTACHED. SITE HAVE HAD 3 SEPARATE PACKS FROM THIS BOX. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25128357 ↗MalfunctionJul 25, 2025Material Separation; Material Separation
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHILE USING THE SUTURE WHEN THE NEEDLE DISLODGED OFF OF THE SUTURE MATERIAL. THEY WANTED TO REPORT THIS ADVERSE EVENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22610147 ↗MalfunctionDec 12, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN ANIMAL PROCEDURE, SHE STATED THE NEEDLE KEPT SEPARATING FROM THE SUTURE. THEY WENT THROUGH THREE SEPARATE SUTURES AND ALL THREE OF THEM HAD THE SAME ISSUE. NO PATIENT HARM REPORTED. NO PRODUCT TO RETURN. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20913263 ↗MalfunctionDec 12, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A ANIMAL PROCEDURE, SHE STATED THE NEEDLE KEPT SEPARATING FROM THE SUTURE. THEY WENT THROUGH THREE SEPARATE SUTURES AND ALL THREE OF THEM HAD THE SAME ISSUE. NO PATIENT HARM REPORTED. NO PRODUCT TO RETURN. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20913262 ↗MalfunctionDec 12, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A ANIMAL PROCEDURE, SHE STATED THE NEEDLE KEPT SEPARATING FROM THE SUTURE. THEY WENT THROUGH THREE SEPARATE SUTURES AND ALL THREE OF THEM HAD THE SAME ISSUE. NO PATIENT HARM REPORTED. NO PRODUCT TO RETURN. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20913132 ↗InjurySep 16, 2024Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 SUTURE WAS USED. THE NEEDLE BROKE OFF SUTURE INSIDE OF PATIENTS HAND. PATIENT TO BE CONSULTED BY PLASTIC SURGEON TO RECOVER. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 20224438 ↗MalfunctionMay 2, 2023Break; Break
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16857731 ↗MalfunctionMay 2, 2023Break; Break
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16857385 ↗MalfunctionMay 2, 2023Break; Break
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16857037 ↗MalfunctionMay 2, 2023Break; Break
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16856886 ↗MalfunctionMay 2, 2023Break; Break
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL SURGERY ON (B)(6) 2023, AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16854932 ↗MalfunctionMay 2, 2023Break; Break
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL SURGERY ON (B)(6) 2023, AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16854930 ↗MalfunctionMay 2, 2023Break; Break
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16854910 ↗MalfunctionMay 2, 2023Break; Break
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16854905 ↗MalfunctionMay 2, 2023Break; Break
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16854899 ↗MalfunctionMay 2, 2023Break; Break
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16854896 ↗MalfunctionMay 2, 2023Break; Break
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16854895 ↗MalfunctionMay 2, 2023Break; Break
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL SURGERY ON (B)(6)2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16854891 ↗MalfunctionApr 21, 2023Material Separation; Material Separation
IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT THEY PURCHASED 4/0 VICRYL SUTURE FROM MWI ANIMAL HEALTH. THE DOCTOR HAD NOTICED THAT A PATTERN OF 3 SUTURES SO FAR FROM THIS BOX HAD BROKEN AT THE NEEDLE WHEN THERE WAS STILL A LOT OF SUTURE UNUSED. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16788125 ↗MalfunctionApr 21, 2023Material Separation; Material Separation
IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT THEY PURCHASED 4/0 VICRYL SUTURE FROM MWI ANIMAL HEALTH. THE DOCTOR HAD NOTICED THAT A PATTERN OF 3 SUTURES SO FAR FROM THIS BOX HAD BROKEN AT THE NEEDLE WHEN THERE WAS STILL A LOT OF SUTURE UNUSED. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16788092 ↗
Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices
- Coated VICRYL VCP433HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death1,093 reports
- Polysorb CL-915Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID503 reports
- Coated VICRYL VCP493HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID435 reports
- V-Loc 180 VLOCL0316Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall376 reports
- Coated VICRYL VCP345HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death405 reports
- V-Loc 180 VLOCL0604Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall328 reports
- V-Loc 180 VLOCA008LCovidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall294 reports
- V-Loc 180 VLOCL0326Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID330 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.