Coated VICRYL J765DRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031042834), received between Nov 20, 2017 and Mar 3, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING SURGERY, THE NEEDLE AND THE SUTURE WAS EASY TO DETACH. IT WAS 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 24503851 ↗
• MalfunctionApr 29, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER: DURING AN OPERATION IN OUR OR, THEY ENCOUNTERED THE ISSUE BELOW WITH A SUTURE PACK THEY RECEIVED FROM CARDINAL. IT APPEARS TO BE A BUG. THE PACK WAS SEALED WHEN BROUGHT INTO THE OPERATING ROOM. THE DEVICE WAS NOT AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926358 ↗
• MalfunctionMar 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE ITEM POPS OUT VERY EASY. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698162 ↗
• MalfunctionFeb 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE MORE QUICKLY THAN USUAL DURING INTERRUPTED SUTURING. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373778 ↗
• MalfunctionFeb 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE MORE QUICKLY THAN USUAL DURING INTERRUPTED SUTURING. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373777 ↗
• MalfunctionFeb 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE MORE QUICKLY THAN USUAL DURING INTERRUPTED SUTURING. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373775 ↗
• MalfunctionFeb 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE MORE QUICKLY THAN USUAL DURING INTERRUPTED SUTURING. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373773 ↗
• MalfunctionNov 14, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR WAS CLOSING THE JOINT CAPSULE AND WAS PULLING THROUGH THE SUTURE WHEN THE NEEDLE FELL OFF BEFORE IT WAS SUPPOSED TO. IT IS UNCLEAR WHETHER THE FRAGMENT WAS RETRIEVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794572 ↗
• MalfunctionMar 3, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OB-GYN ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664759 ↗
• MalfunctionJan 26, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UTERINE MYOMECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING SUTURE OF THE ABDOMINAL WALL FASCIA SUTURE BREAKAGE OCCURRED FREQUENTLY DURING LIGATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13358466 ↗
• MalfunctionJan 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13286238 ↗
• MalfunctionJan 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13286158 ↗
• MalfunctionDec 28, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UTERINE MYOMECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING SUTURE OF THE ABDOMINAL WALL FASCIA SUTURE BREAKAGE OCCURRED FREQUENTLY DURING LIGATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13101382 ↗
• MalfunctionNov 20, 2017Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2017 AND SUTURE WAS USED. IT WAS FOUND THAT THERE WAS A SUTURE WITH THE THICKNESS OF 2-0 IN THE PACKAGE BEFORE USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7046267 ↗