VICRYL RAPIDE VR945Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10705031133358), received between Dec 18, 2017 and Sep 18, 2024 — classified as 8 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERINEOTOMY AFTER A DELIVERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WITH INTERRUPTED SUTURE FOR PERINEUM, THE NEEDLE WAS DETACHED EASILY. THERE WAS NO OPERATION TIME EXTENSION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20247467 ↗
• MalfunctionSep 4, 2024Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT IN THE ICU, WHEN OPENED THE PACKAGE, THE SUTURE WAS STUCK TO THE PACKAGE. WHEN LOOKED DIRECT INSPECTION, THE PACKAGE WAS STUCK TO THE SUTURE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. 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 20137474 ↗
• MalfunctionFeb 29, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CHILDBIRTH PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. WHEN THE NEEDLE PASSED THROUGH THE TISSUE DURING PERINEAL SUTURE, THE SUTURE BROKE IMMEDIATELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18810707 ↗
• MalfunctionFeb 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OB-GYN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN OB-GYN SURGERY, THE SUTURE BROKE WHEN THE SURGEON WAS TYING IT. THIS HAPPENED IN 2 PRODUCTS. THE SURGEON APPLIED ADDITIONAL SUTURES AND THERE IS NO EFFECT ON THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18760144 ↗
• MalfunctionFeb 21, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OB-GYN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN OB-GYN SURGERY, THE SUTURE BROKE WHEN THE SURGEON WAS TYING IT. THIS HAPPENED IN 2 PRODUCTS. THE SURGEON APPLIED ADDITIONAL SUTURES AND THERE IS NO EFFECT ON THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748439 ↗
• MalfunctionNov 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN UNKNOWN OB-GYN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092980 ↗
• MalfunctionJul 11, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17300196 ↗
• MalfunctionJul 11, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17299941 ↗
• MalfunctionJul 11, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17299939 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY ON (B)(6) 2023 AND SUTURE WAS USED FOR PERINEAL SUTURE. THEN, IN THE WARD/ICU, THE PATIENT STATED IT HURT. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL FOR TREATMENT. THEREAFTER, THE PATIENT GOT BETTER WITHOUT ANY SPECIAL TREATMENT. THE PATIENT DOES NOT NEED TO GO TO THE HOSPITAL NOW. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body Reaction; Granuloma; Pain

  MAUDE report 17211069 ↗
• MalfunctionMay 24, 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 WHEN TAKING OUT THE SUTURE FROM THE PACKAGE, THE NEEDLE WAS DETACHED FROM THE SUTURE IMMEDIATELY. 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 16998469 ↗
• MalfunctionMay 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CHILDBIRTH PROCEDURE (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE THE PRODUCT WAS USED FOR PERINEAL SUTURE. THE NEEDLE WAS DETACHED FROM THE SUTURE EVEN THOUGH THE SURGEON DID NOT APPLY ANY FORCE AT ALL DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16966182 ↗
• MalfunctionMay 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CHILDBIRTH PROCEDURE (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE THE PRODUCT WAS USED FOR PERINEAL SUTURE. THE NEEDLE WAS DETACHED FROM THE SUTURE EVEN THOUGH THE SURGEON DID NOT APPLY ANY FORCE AT ALL DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16966162 ↗
• InjuryMay 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE WHEN SUTURE THE PERINEUM. THE NEEDLE WENT MISSING. THE NEEDLE COULD NOT BE FOUND SO THE PATIENT WAS TRANSPORTED TO A DIFFERENT HOSPITAL. THEN, THE NEEDLE WAS FOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16876067 ↗
• MalfunctionMay 4, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT NATURAL CHILDBIRTH ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE PERINEUM. THE PATIENT'S PERINEUM DEHISCED. THE LOWER PART WAS DEHISCENT. SOME PATIENTS USED ACRINOL. THE SURGEON OPINES THAT THERE IS NO TENDENCY FOR THE SUTURE TO EASILY DISSOLVE OR CAUSE DEHISCENCE BECAUSE OF THIS USE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE SURGEON DOES NOT THINK THERE IS A CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND THE EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 16873839 ↗
• MalfunctionMay 4, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT NATURAL CHILDBIRTH ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE PERINEUM. THE PATIENT'S PERINEUM DEHISCED. THE LOWER PART WAS DEHISCENT. SOME PATIENTS USED ACRINOL. THE SURGEON OPINES THAT THERE IS NO TENDENCY FOR THE SUTURE TO EASILY DISSOLVE OR CAUSE DEHISCENCE BECAUSE OF THIS USE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE SURGEON DOES NOT THINK THERE IS A CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND THE EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 16873835 ↗
• MalfunctionMay 4, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT NATURAL CHILDBIRTH ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE PERINEUM. THE PATIENT'S PERINEUM DEHISCED. THE LOWER PART WAS DEHISCENT. SOME PATIENTS USED ACRINOL. THE SURGEON OPINES THAT THERE IS NO TENDENCY FOR THE SUTURE TO EASILY DISSOLVE OR CAUSE DEHISCENCE BECAUSE OF THIS USE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE SURGEON DOES NOT THINK THERE IS A CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND THE EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 16873834 ↗
• MalfunctionMay 4, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT NATURAL CHILDBIRTH ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE PERINEUM. THE PATIENT'S PERINEUM DEHISCED. THE LOWER PART WAS DEHISCENT. SOME PATIENTS USED ACRINOL. THE SURGEON OPINES THAT THERE IS NO TENDENCY FOR THE SUTURE TO EASILY DISSOLVE OR CAUSE DEHISCENCE BECAUSE OF THIS USE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE SURGEON DOES NOT THINK THERE IS A CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND THE EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 16873833 ↗
• MalfunctionMay 4, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT NATURAL CHILDBIRTH ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE PERINEUM. THE PATIENT'S PERINEUM DEHISCED. IN ONE CASE, THE SUTURE WAS DISSOLVED ON THE THIRD POSTOPERATIVE DAY. THE LOWER PART WAS DEHISCENT. SOME PATIENTS USED ACRINOL. THE SURGEON OPINES THAT THERE IS NO TENDENCY FOR THE SUTURE TO EASILY DISSOLVE OR CAUSE DEHISCENCE BECAUSE OF THIS USE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE SURGEON DOES NOT THINK THERE IS A CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND THE EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 16873832 ↗
• MalfunctionMay 4, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT NATURAL CHILDBIRTH ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE PERINEUM. THE PATIENT'S PERINEUM DEHISCED. THE LOWER PART WAS DEHISCENT. SOME PATIENTS USED ACRINOL. THE SURGEON OPINES THAT THERE IS NO TENDENCY FOR THE SUTURE TO EASILY DISSOLVE OR CAUSE DEHISCENCE BECAUSE OF THIS USE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE SURGEON DOES NOT THINK THERE IS A CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND THE EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 16873831 ↗
• MalfunctionMay 2, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OBSTETRICAL DELIVERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE PERINEUM. THE SUTURE WAS BROKEN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16853893 ↗
• InjuryMay 2, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT NATURAL CHILDBIRTH ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE PERINEUM. DURING THE PROCEDURE, THE SUTURE BROKE WHEN SUTURING THE PERINEUM AND THE NEEDLE WENT MISSING. BECAUSE THE PATIENT WAS BLEEDING HEAVILY AND NEEDED A BLOOD TRANSFUSION, THE PATIENT WAS TRANSPORTED TO ANOTHER HOSPITAL. THEN, THE NEEDLE WAS FOUND. AT THE TIME OF NEEDLE SEARCHING, IMAGING TEST WAS PERFORMED. THE NEEDLE WAS REMOVED FROM THE PATIENT¿S BODY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16852165 ↗
• InjuryMay 3, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL CHILDBIRTH DELIVERY IN (B)(6) 2022 AND SUTURE WAS USED FROM THE PERINEUM TO THE VAGINA DUE TO TWO TIMES OF LACERATIONS. IN (B)(6)2022, 3 MONTHS LATER, THE PATIENT WAS UNABLE TO HAVE SEXUAL INTERCOURSE AND VISITED THE HOSPITAL. THE PATIENT PRESENTED WITH INTRAVAGINAL ABSCESS. IT WAS FOUND THAT THE VAGINA WAS NARROWED LIKE AN ILEUS FOR SEVERAL CENTIMETERS FROM THE PLACE ENTERED FROM THE VULVA, AND CORD-LIKE TISSUE WAS FORMED. AFTER THAT, THE PATIENT WAS REFERRED TO A UNIVERSITY HOSPITAL. A DOCTOR AT THE UNIVERSITY HOSPITAL STATED THAT IT WAS A HIGH POSSIBILITY OF FOREIGN SUBSTANCE THOUGHT TO BE RESIDUAL SUTURE THAT REMAINED IN THE VAGINA. THE DOCTOR BELIEVED THAT THE FOREIGN SUBSTANCE CAUSED ABSCESS FORMATION. ALSO, IT WAS REPORTED THAT REMOVAL OF CORD-LIKE TISSUE MAY BE REQUIRED AT A LATER DATE. THE DOCTOR BELIEVED THAT SUTURE IN THE PERINEUM WAS ALREADY HYDROLYZED AT THE TIME OF THE APRIL VISIT BUT REMAINED IN THE VAGINA. A PHYSICIAN AT THE (B)(6) HOSPITAL SAID THAT IT IS UNKNOWN IF THERE IS A REMAINING SUTURE BUT THERE IS A POSSIBILITY. IT WAS UNKNOWN IF THERE WAS CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND EVENT AT THE CURRENT TI

  Patient problems: Abscess; Foreign Body Reaction

  MAUDE report 14269051 ↗
• MalfunctionApr 27, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES WERE DETACHED FROM THE SUTURES. THEY WERE NOT CONTROL RELEASE NEEDLES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14225325 ↗
• MalfunctionFeb 7, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. AFTER THE PACKAGE WAS OPENED, THERE WAS AN ABNORMALITY IN THE LENGTH OF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476487 ↗