VICRYL RAPIDE VR214Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031134607), received between Aug 21, 2019 and Nov 24, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (10 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.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATICODUODENECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN OPEN PANCREATICODUODENECTOMY, WHEN USING THIS PRODUCT FOR FIXING THE PANCREATIC DUCT TUBE, THE SUTURE WAS BROKEN. ANOTHER PRODUCT WAS USED. THE SUTURE WAS USED FOR THE IMPORTANT PART, AND THE TENSILE STRENGTH OF THE SUTURE WAS ORIGINALLY WEAK, SO THE DOCTOR CONCERNED THAT AND REQUESTED TO INVESTIGATE THE REMAINING 7 PACKAGES WITH THE SAME LOT NUMBER. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633819 ↗
• MalfunctionAug 28, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT ACCOUNT HAD AN OPEN BOX OF 4-0 VICRYL RAPIDE THAT DOCTOR WAS USING DURING SURGERY AND 2 SEPARATE REELS HAD THE SUEDGED ON NEEDLE POP OFF DURING SUTURING. THEY DID HAVE AN UNOPENED BOX AVAILABLE WITH A DIFFERENT LOT NUMBER AND EXPIRATION DATE, AND SUTURE FROM THAT BOX HAD NO ISSUES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916413 ↗
• MalfunctionAug 28, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT ACCOUNT HAD AN OPEN BOX OF 4-0 VICRYL RAPIDE THAT DOCTOR WAS USING DURING SURGERY AND 2 SEPARATE REELS HAD THE SUEDGED ON NEEDLE POP OFF DURING SUTURING. THEY DID HAVE AN UNOPENED BOX AVAILABLE WITH A DIFFERENT LOT NUMBER AND EXPIRATION DATE, AND SUTURE FROM THAT BOX HAD NO ISSUES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916400 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806882 ↗
• MalfunctionMay 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT NEEDLE FALLING OFF SUTURE DURING USE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037281 ↗
• MalfunctionMay 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT NEEDLE FALLING OFF SUTURE DURING USE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037280 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE SUTURE WAS BROKEN AT THE ROOT OF THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19618113 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE SUTURE WAS BROKEN AT THE ROOT OF THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19618068 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE SUTURE WAS BROKEN AT THE ROOT OF THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19618066 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE SUTURE WAS BROKEN AT THE ROOT OF THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19618048 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PHIMOSIS PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE SUTURE WAS BROKEN DURING USE. IT WAS TRIED TO SUTURE AGAIN WITH THE SUTURE THAT BROKE, BUT THE SUTURE WAS BROKEN AGAIN, AND ALSO BROKE SEVERAL TIMES AFTER THAT. SO, A NEW SUTURE FROM A DIFFERENT LOT WAS USED FOR SUTURING. IN THAT CASE, THE SUTURE BREAKAGE DID NOT OCCUR, AND IT WAS DONE FOR SUTURING WITHOUT PROBLEM. THERE WAS NO BAD EFFECT TO THE PATIENT. IT WAS NOT A CONTROL RELEASE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457524 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, THE NEEDLE BROKE BEFORE USE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO SAMPLE WILL BE RETURNED. THE VISUAL ASSESSMENT OF THE RETURNED SAMPLE REVEALED THAT THE NEEDLE WAS NOT RETURNED FOR EVALUATION. IN ADDITION, THE SUTURE HAS STARTED WITH THE DEGRADATION PROCESS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18726972 ↗
• MalfunctionJul 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE FROM THE BASE OF THE NEEDLE. ANOTHER PRODUCT WAS USED BUT THE SAME THING HAPPENED AGAIN, SO THE PRODUCT WAS ATTACHED TO A BULLET NEEDLE AND SUTURED, THEN ITS SUTURE BROKE IN THE MIDDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17404697 ↗
• MalfunctionJun 29, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOT-ASSISTED RADICAL CYSTECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE THE URETERAL STENT WAS BEING FIXED, THE NEEDLE AND SUTURE WERE DETACHED IN THE ABDOMINAL CAVITY. THE NEEDLE POPPED OFF AND PRICKED THE ABDOMINAL WALL, SO IT WAS FOUND IMMEDIATELY. THE PRODUCT WAS USED FOR CONTINUOUS SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14865439 ↗
• MalfunctionJun 2, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON UNKNOWN DATE AND THE SUTURE WAS USED. DURING THE SURGERY, IT WAS FOUND THAT THE LETTERS PRINTED ON THE LABEL ON THE BOX WAS WRONG. MEANING, THE LETTERS SHOULD MEAN "TAPER POINT.¿ HOWEVER, THE ACTUAL LETTERS ON THE BOX MEAN REVERSE CUTTING NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10113329 ↗
• MalfunctionDec 17, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9485478 ↗
• MalfunctionDec 17, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9485476 ↗
• MalfunctionAug 21, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN NKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8915123 ↗