VICRYL RAPIDE VR496Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031134690), received between Aug 14, 2018 and Mar 2, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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.

Recalls naming this device

1. 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

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING POST OP, THE DEVICE DID NOT BREAK DOWN IN THE BODY AS EXPECTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489377 ↗
• MalfunctionJul 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CUSTOMER REPORTED THAT SUTURES WERE BREAKING EASILY DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818387 ↗
• MalfunctionJul 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CUSTOMER REPORTED THAT SUTURES WERE BREAKING EASILY DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818385 ↗
• MalfunctionSep 15, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT RADICAL NEPHRECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE PULLING TO TIGHTEN SUTURE, THE DEVICE BROKE. THEY OPENED UP TWO DEVICES AND ONE OF THEM BROKE. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17755609 ↗
• MalfunctionSep 15, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT RADICAL NEPHRECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE PULLING TO TIGHTEN SUTURE, THE DEVICE BROKE. THEY OPENED UP TWO DEVICES AND ONE OF THEM BROKE. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17755605 ↗
• MalfunctionDec 30, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN EASILY DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16077388 ↗
• MalfunctionJan 7, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A DENTAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9557896 ↗
• MalfunctionOct 30, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KNOTS OR THE SUTURE WAS UNRAVELING. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9254599 ↗
• MalfunctionOct 28, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT RETURNED FOR A FOLLOW-UP AND THE SUTURE KNOTS HAD UNRAVELED. ADDITIONAL SUTURE WAS NOT ADDED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9245389 ↗
• MalfunctionOct 31, 2018Break; Break

  THIS REPORT SUMMARIZES <NOE> 517 </NOE> MALFUNCTION EVENTS, INCLUDING 242 SUTURE BREAKAGE, 111 NEEDLE BREAKAGE AND 164 DETACHMENT OF DEVICE COMPONENT THAT OCCURRED INTRAOPERATIVELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8023987 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT TRIGGER FINGER PROCEDURE ON UNKNOWN DATE IN (B)(6) 2017 AND SUTURE WAS USED. THE PATIENT EXPERIENCED SWELLING, JOINT PAIN, AND A SOMETHING WAS FORMING A HEAD THROUGH THE SKIN REACTION ONE MONTH POST OP. THE PATIENT REPORTS HAVING CONTRACTIONS IN THE KNUCKLES. THE PATIENT HAS BEEN TREATED BY THE HAND SURGEON WITH STEROID INJECTIONS, ULTRASONIC THERAPY AND PHYSICAL THERAPY. THE HAND SURGEON RECOMMENDED FOLLOW UP WITH RHEUMATOLOGIST FOR FURTHER TESTING. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Foreign Body Reaction; Pain; Swelling

  MAUDE report 7782398 ↗