VICRYL RAPIDE VR944Recalls & reported problems
Ethicon, LLC · Undyed Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant
Quick summary
This Ethicon Vicryl Rapide absorbable surgical suture is a braided synthetic stitch that dissolves over time. Most of the 49 reports describe the thread snapping during surgery or fraying and separating, and a few mention a needle breaking off in the patient. There are 6 reports of injuries, including wounds reopening after surgery, and no deaths. No recalls name this device.
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
- 47
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10705031147935), received between Apr 29, 2019 and Aug 24, 2026 — classified as 6 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Break” (24 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.
Reports received per month
Most reported problems
Device problems
- Break24
- Material Separation17
- Adverse Event Without Identified Device or Use Problem4
- Material Integrity Problem2
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Consequences Or Impact To Patient14
- Wound Dehiscence6
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50419127 ↗InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The patient experienced a wound dehiscence recently after using the suture. Additional information was requested.
Patient problems: Wound Dehiscence
MAUDE report 50167348 ↗MalfunctionJan 9, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL REPAIR PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SALES REP IS REPORTING FROM THE CUSTOMER THAT THE NEEDLE SNAPPED OFF INTO THE PATIENT DURING A PROCEDURE. NO PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21114432 ↗MalfunctionJan 9, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL REPAIR PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SALES REP IS REPORTING FROM THE CUSTOMER THAT THE NEEDLE SNAPPED OFF INTO THE PATIENT DURING A PROCEDURE. NO PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21114118 ↗MalfunctionJan 9, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL REPAIR PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SALES REP IS REPORTING FROM THE CUSTOMER THAT THE NEEDLE SNAPPED OFF INTO THE PATIENT DURING A PROCEDURE. NO PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21114116 ↗MalfunctionJan 9, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL REPAIR PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SALES REP IS REPORTING FROM THE CUSTOMER THAT THE NEEDLE SNAPPED OFF INTO THE PATIENT DURING A PROCEDURE. NO PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21113640 ↗MalfunctionNov 13, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING AN UNKNOWN OB-GYN SURGERY, DURING INTERRUPTED SUTURE, THE SUTURE WAS BROKEN FROM NEAR THE JOINT OF THE NEEDLE AND SUTURE WHEN USE. IT OCCURRED 2 SUTURES IN AROW. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO SAMPLE WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20675077 ↗MalfunctionNov 13, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING AN UNKNOWN OB-GYN SURGERY, DURING INTERRUPTED SUTURE, THE SUTURE WAS BROKEN FROM NEAR THE JOINT OF THE NEEDLE AND SUTURE WHEN USE. IT OCCURRED 2 SUTURES IN AROW. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO SAMPLE WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20675065 ↗MalfunctionJun 21, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE DERMIS. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE ROOT IN A ROW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19583281 ↗MalfunctionJun 21, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE DERMIS. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE ROOT IN A ROW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19583279 ↗MalfunctionJun 21, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE DERMIS. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE ROOT IN A ROW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19583278 ↗MalfunctionJun 21, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE DERMIS. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE ROOT IN A ROW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19583273 ↗MalfunctionJun 21, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE DERMIS. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE ROOT IN A ROW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19583157 ↗MalfunctionJun 21, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE DERMIS. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE ROOT IN A ROW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19583148 ↗MalfunctionJun 21, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE DERMIS. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE ROOT IN A ROW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19583053 ↗MalfunctionJun 21, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE DERMIS. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE ROOT IN A ROW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19583045 ↗MalfunctionJun 21, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE DERMIS. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE ROOT IN A ROW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19582893 ↗MalfunctionJun 21, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE DERMIS. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE ROOT IN A ROW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19582890 ↗MalfunctionAug 8, 2023Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE SURGERY, WHEN THE SURGEON HELD THE NEEDLE, IT WAS FOUND THAT THE SUTURE WAS ALREADY DETACHED FROM THE NEEDLE. 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 17480449 ↗MalfunctionFeb 16, 2023Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE FRAYED DURING USE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16390050 ↗MalfunctionJan 25, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. AFTER OPENING THE PACKAGE BEFORE USE, IT WAS FOUND THAT THE SUTURE HAD DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16241937 ↗MalfunctionJun 27, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE. THE PRODUCT WAS NOT USED FOR THE SURGERY. IT WAS NOT A CONTROL RELEASE NEEDLE. UPON RETURN OF THE SAMPLE, THE TOP FOIL WAS VISUALLY INSPECTED, AND HOLES IN THE CAVITY WERE OBSERVED. THIS CONDITION CONTRIBUTED TO THE DEGRADATION OF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14831823 ↗MalfunctionMar 22, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE BREAKAGE OCCURRED DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13849984 ↗MalfunctionMar 22, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE BREAKAGE OCCURRED DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13849896 ↗MalfunctionMar 22, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE BREAKAGE OCCURRED DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13849885 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.