VICRYL RAPIDE VR426Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031134669), received between Dec 17, 2020 and Jan 21, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS USED TO SEW SKIN AND BROKE DURING SURGERY. THE SURGERY PROLONGED ABOUT 1 HOUR SINCE SUTURE BREAKAGE OCCURRED SEVERAL TIMES. THE PATIENT IS STABLE NOW. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24131601 ↗
• MalfunctionJan 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS USED TO SEW SKIN AND BROKE DURING SURGERY. THE SURGERY PROLONGED ABOUT 1 HOUR SINCE SUTURE BREAKAGE OCCURRED SEVERAL TIMES. THE PATIENT IS STABLE NOW. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24131585 ↗
• MalfunctionAug 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. DURING THE SUTURING PROCESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE SUDDENLY HAPPENED. IT WAS CONFIRMED WHETHER THE SUTURE NEEDLE WAS INTACT. A NEW SUTURE WAS USED IMMEDIATELY TO SUTURE THE SURGICAL INCISION, ENSURING THE PATIENT'S SAFETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814923 ↗
• MalfunctionOct 17, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SALPINGECTOMY LAPAROSCOPY, BILATERAL HYSTEROSCOPY WITH ABLATION TISSUE, HYSTEROSCOPY DILATATION AND CURETTAGE WI SURGICAL PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM, #(B)(4), SALPINGECTOMY LAPAROSCOPY, BILATERAL HYSTEROSCOPY WITH ABLATION TISSUE, HYSTEROSCOPY DILATATION AND CURRETAGE WI SURGICAL PROCEDURE WAS CONCLUDED, SURGEON WAS SUTURING THE INCISION SITES. PREFERRED SUTURE IS BEING REPLACED, AND THE NEW ONE WAS USED. WHILE SUTURING THE INCISION SITE, THE SUTURE THREAD BROKE MULTIPLE TIMES. SURGEON WAS UNSATISFIED WITH THE REPLACEMENT SUTURE. HE BELIEVES THE BREAK IN THE SUTURE MAY HAVE CAUSED A HEMATOMA. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hematoma

  MAUDE report 20473017 ↗
• MalfunctionOct 17, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SALPINGECTOMY LAPAROSCOPY, BILATERAL HYSTEROSCOPY WITH ABLATION TISSUE, HYSTEROSCOPY DILATATION AND CURETTAGE WI SURGICAL PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM, #(B)(4), SALPINGECTOMY LAPAROSCOPY, BILATERAL HYSTEROSCOPY WITH ABLATION TISSUE, HYSTEROSCOPY DILATATION AND CURRETAGE WI SURGICAL PROCEDURE WAS CONCLUDED, SURGEON WAS SUTURING THE INCISION SITES. PREFERRED SUTURE IS BEING REPLACED, AND THE NEW ONE WAS USED. WHILE SUTURING THE INCISION SITE, THE SUTURE THREAD BROKE MULTIPLE TIMES. SURGEON WAS UNSATISFIED WITH THE REPLACEMENT SUTURE. HE BELIEVES THE BREAK IN THE SUTURE MAY HAVE CAUSED A HEMATOMA. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hematoma

  MAUDE report 20472988 ↗
• MalfunctionNov 11, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SEPTOPLASTY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. WHILE THE DOCTOR WAS SUTURING, THE TIP OF THE SUTURE NEEDLE BROKE OFF. THE TWO PIECES WERE REMOVED FROM THE FAILED DEVICE AND PLACED INTO A SPECIMEN CUP AND PLACED IN A BAG ALONG WITH THE SUTURE PACKAGING AND THE BOX OF REMAINING SUTURE OF THAT LOT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15780653 ↗
• MalfunctionDec 17, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HAND PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THE BROKEN NEEDLE FOUND AND REMOVE FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11030382 ↗