VICRYL RAPIDE VR935Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705031134799), received between Jan 14, 2021 and Apr 8, 2026 — classified as 6 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE MIDWIFE SEWED THE 1ST DEGREE PERINEAL LACERATION FOR THE PARTURIENT. DURING THE SEWING PROCESS, THE NEEDLE PULL OFF ISSUE SUDDENLY HAPPENED. THE MIDWIFE IMMEDIATELY REPLACED THE SUTURE OF THE SAME MODEL AND BATCH NUMBER TO COMPLETE THE REMAINING SUTURE, AND THE WHOLE PROCESS DID NOT AFFECT THE DELIVERY OUTCOME. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821155 ↗
• MalfunctionFeb 26, 2026Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE AT THE WARDS/ICU, WHEN THE NEEDLE WAS PULLED, THE SUTURES WERE BROKEN OR DETACHED FROM THE NEEDLE SWAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24459942 ↗
• MalfunctionFeb 26, 2026Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE AT THE WARDS/ICU, WHEN THE NEEDLE WAS PULLED, THE SUTURES WERE BROKEN OR DETACHED FROM THE NEEDLE SWAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24459813 ↗
• MalfunctionFeb 26, 2026Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE AT THE WARDS/ICU, WHEN THE NEEDLE WAS PULLED, THE SUTURES WERE BROKEN OR DETACHED FROM THE NEEDLE SWAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24459382 ↗
• InjuryDec 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT VAGINAL CHILDBIRTH ON (B)(6) 2025 AND SUTURE WAS USED. POSTPARTUM PERINEAL SEWING WAS USED FOR PERINEAL MUSCLE LAYER USING CONTINUED SEWING. THE NEEDLE AND SUTURE WERE SEPARATED DURING THE SEWING, AND THE DETACHED NEEDLE FELL INTO THE PATIENT'S TISSUE. AND THEN THE PATIENT WAS IMMEDIATELY GIVEN CT EXAMINATION TO LOOK FOR THE DETACHED NEEDLE AND FINALLY FIND IT. THE PERINEAL WOUND WAS RE-OPENED TO REMOVE THE DETACHED NEEDLE. THE INTEGRITY OF THE NEEDLE WAS VERIFIED AFTER REMOVAL. THE SURGERY WAS COMPLETED ROUTINELY AFTER CONFIRMING THAT THERE WAS NO RESIDUAL IN THE PATIENT'S TISSUE. SURGERY TIME WAS EXTENDED ABOUT 30 MINUTES DUE TO THIS EVENT AND NO FURTHER ADVERSE EVENTS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23853557 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SUTURING, WHEN PULLING THE SUTURE, IT BROKE FROM THE ROOT PART OF THE NEEDLE AND DETACHED. ALL PRODUCTS WERE OPENED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646194 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SUTURING, WHEN PULLING THE SUTURE, IT BROKE FROM THE ROOT PART OF THE NEEDLE AND DETACHED. ALL PRODUCTS WERE OPENED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646189 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SUTURING, WHEN PULLING THE SUTURE, IT BROKE FROM THE ROOT PART OF THE NEEDLE AND DETACHED. ALL PRODUCTS WERE OPENED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646184 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SUTURING, WHEN PULLING THE SUTURE, IT BROKE FROM THE ROOT PART OF THE NEEDLE AND DETACHED. ALL PRODUCTS WERE OPENED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646183 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SUTURING, WHEN PULLING THE SUTURE, IT BROKE FROM THE ROOT PART OF THE NEEDLE AND DETACHED. ALL PRODUCTS WERE OPENED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646182 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SUTURING, WHEN PULLING THE SUTURE, IT BROKE FROM THE ROOT PART OF THE NEEDLE AND DETACHED. ALL PRODUCTS WERE OPENED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646175 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SUTURING, WHEN PULLING THE SUTURE, IT BROKE FROM THE ROOT PART OF THE NEEDLE AND DETACHED. ALL PRODUCTS WERE OPENED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646173 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT INCISION AND INTERNAL FIXATION OF PHALANX FRACTURES ON (B)(6) 2025, AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW SURGICAL INCISION. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22810257 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, DURING NORMAL CHECKING, IT WAS FOUND THAT THE SUTURE BROKEN IN THE NEWLY DISPENSED SUTURE WITH A LIGHT PULL. UPON VISUAL ASSESSMENT OF THE RETURNED SAMPLE, IT WAS OBSERVED THAT THE STRAND WAS BROKEN IN SEVERAL PIECES DUE TO IT HAD BEGUN WITH A DEGRADATION PROCESS CAUSED BY EXPOSURE TO THE ENVIRONMENT. THE FOIL WAS VISUALLY INSPECTED, WRINKLES AND HOLES IN THE CAVITY WERE OBSERVED. THE CONDITION OF THE PACKAGE IS INDICATIVE OF HANDLING AND STORAGE ISSUES THAT OCCURRED OUTSIDE OF ETHICON CONTROL. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22559882 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY THE HEALTHCARE PROFESSIONAL REGARDING 3 SUTURES THAT SNAPPED DURING SURGERY AND THE SURGEON TOOK 6 BOXES OFF THE SHELF. THE DEVICES ARE AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21141425 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY THE HEALTHCARE PROFESSIONAL REGARDING 3 SUTURES THAT SNAPPED DURING SURGERY AND THE SURGEON TOOK 6 BOXES OFF THE SHELF. THE DEVICES ARE AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21141416 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY THE HEALTHCARE PROFESSIONAL REGARDING 3 SUTURES THAT SNAPPED DURING SURGERY AND THE SURGEON TOOK 6 BOXES OFF THE SHELF. THE DEVICES ARE AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21141397 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERINEAL LACERATION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NURSING STAFF PERFORMED PERINEAL SUTURING AND KNOTTING ON A PARTURIENT WITH A PERINEAL LACERATION. WHEN THE SUTURE BROKE, THE NURSE IMMEDIATELY REPLACED IT AND REMOVED THE PREVIOUSLY STITCHED MATERIAL TO RE SUTURE IT UNTIL THE SURGERY WAS COMPLETED. THIS EVENT RESULTED IN AN EXTENDED SURGICAL TIME, AND THE TORN SKIN OF THE PATIENT MAY REQUIRE SECONDARY OR EVEN TERTIARY SUTURES, INCREASING THE PATIENT'S PSYCHOLOGICAL BURDEN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19921607 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERINEAL LACERATION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE INTRADERMAL SUTURE OF THE LAST LAYER OF EPIDERMIS, THE SUTURE WAS PRONE TO BREAKAGE WHEN KNOTTED. AFTER THE SUTURE BROKE, THE DOCTOR IMMEDIATELY REPLACED THE SUTURE AND CONTINUED THE SURGERY UNTIL THE SURGERY WAS COMPLETED. THE SUTURE IS PRONE TO BREAKAGE, WHICH AFFECTS THE SURGICAL PROGRESS. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906956 ↗
• MalfunctionDec 28, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A LEFT PERINEAL INCISION WOUND ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCESS OF SUTURING THE PATIENT'S SKIN, MEDICAL STAFF FOUND THAT THE NEEDLE TIP BROKE WHILE FIXING THE FIRST NEEDLE. IMMEDIATELY REPLACE THE NEW SUTURE AND REQUEST THE MIDWIFE TO CHECK IF THE SUTURE IS INTACT AND FREE OF DEFECTS WHEN TAKEN OUT OF THE PACKAGING. FINALLY, COMPLETE THE SKIN SUTURE OF THE LATERAL INCISION WOUND. THIS INCIDENT DELAYED THE PATIENT'S TREATMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18408960 ↗
• MalfunctionAug 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(4) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE OCCURRED DURING SURGERY. THE CUSTOMER COULD NOT CONFIRM WHICH LOT NUMBER WAS ACTUALLY INVOLVED IN THE SURGERY, BUT PROVIDED THE POSSIBLE LOT NUMBERS WERE: AT2732 AND AT2729. THE CUSTOMER REFUSED TO USE THE 3 STERILE PRODUCTS FROM BOTH LOTS AND THEY WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17574027 ↗
• MalfunctionAug 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE OCCURRED DURING SURGERY. THE CUSTOMER COULD NOT CONFIRM WHICH LOT NUMBER WAS ACTUALLY INVOLVED IN THE SURGERY, BUT PROVIDED THE POSSIBLE LOT NUMBERS WERE: AT2732 AND AT2729. THE CUSTOMER REFUSED TO USE THE 3 STERILE PRODUCTS FROM BOTH LOTS AND THEY WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17574025 ↗
• MalfunctionAug 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LATERAL EPISIOTOMY. PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE . IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN THE SURGEON ATTEMPTED TO SEW LATERAL SEROSAL LAYER AT THE SECOND STITCH IN LATERAL EPISIOTOMY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573928 ↗
• MalfunctionJun 12, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE UNKNOWN SURGERY, THE NEEDLE HAD BEEN FOUND BROKEN BEFORE USING ON PATIENT DURING SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106219 ↗
• InjuryNov 3, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE WHEN SEWING THE WOUND IN THE PERINEAL INCISION. THE NEEDLE WAS NOT FOUND AT THAT TIME. THE NEXT DAY, IT WAS FOUND IN THE PHOTO THAT THE NEEDLE WAS AT THE MUSCLE LAYER OF THE PERINEAL WOUND. UNDER SPINAL ANESTHESIA, THE NEEDLE WAS REMOVED FROM THE PERINEAL WOUND, THE SUTURE WAS REPLACED, AND THE PERINEAL WOUND WAS SUTURED AGAIN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15723080 ↗