Coated VICRYL J864DRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705031000278), received between Feb 5, 2019 and May 21, 2025 — classified as 5 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE THAT IT WAS NOTICED THAT THE INCORRECT SUTURE WAS IN THE PACKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064087 ↗
• MalfunctionFeb 4, 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 A SUTURE WAS USED. WHEN THE ACCOUNT OPENED THE PACKAGE OF THE POP OFF, THE BACK OF THE ORGANIZER TRAY HAD A VISIBLE BLACK THING ON IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303614 ↗
• MalfunctionMay 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THREE NEEDLE TIPS BROKE OFF DURING THE CASE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16995397 ↗
• MalfunctionMay 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THREE NEEDLE TIPS BROKE OFF DURING THE CASE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16994517 ↗
• MalfunctionMay 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THREE NEEDLE TIPS BROKE OFF DURING THE CASE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16994514 ↗
• MalfunctionDec 9, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF LIPOMA PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES ARE BREAKING. THEY DID TAKE AN X-RAY, BUT DID NOT RETRIEVE THE NEEDLES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15951449 ↗
• MalfunctionDec 9, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF LIPOMA PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES ARE BREAKING. THEY DID TAKE AN X-RAY, BUT DID NOT RETRIEVE THE NEEDLES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15951401 ↗
• MalfunctionAug 24, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FACILITY IS NOTICING SMALL HOLES IN THE PACKAGING AS THEY ARE OPENING THEM. FACILITY STATED THAT WHEN THERE ARE CREASES OR FOLDS IN THE FOIL THAT IT CREATES HOLES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15288706 ↗
• MalfunctionAug 22, 2022Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY AN EMPLOYEE PER THE ACCOUNT: "THE OR AT LD HAS BEEN NOTICING SMALL HOLES IN THE SUTURE PACKAGING AFTER THEY OPEN THEM. THE INDIVIDUAL SUTURES COME IN ¿FOIL¿ PACKS AND IF THE PACKS GET A BEND OR CREASE IN THEM, THERE IS A CHANCE IT MAY CREATE A WHOLE. ETHICON DOES PACKAGE SOME OF THEIR SUTURE LIKE PROLENE IN A CLEAR PLASTIC PEEL PACKS THAT HOLD UP BETTER." IT IS UNKNOWN IF THE DEVICES ARE AVAILABLE FOR RETURN.. ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15272460 ↗
• MalfunctionJun 30, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT WHEN THE SUTURE PACKET J864D WAS OPENED INSIDE THE PACKET WAS VCP864D AS IT WAS LABELED ON PLASTIC SUTURE RETAINER. ANOTHER SUTURE PACKET WAS OPENED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14878609 ↗
• MalfunctionMar 8, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMPECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE WAS RETURNED TO THE NEEDLE BOOK IT WAS NOTICED THAT THE TIP OF THE NEEDLE WAS MISSING. MISSING PIECE WAS FOUND ON THE BACK TABLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13699499 ↗
• MalfunctionMar 8, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMPECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING USE ON THE PATIENT, THE NEEDLE WAS REMOVED THE SURGEON SAW THE TIP FALL OFF THE NEEDLE AND INTO THE DRAPES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13698968 ↗
• MalfunctionApr 2, 2021Packaging Problem

  8-PACK OF VICRYL 3-0 SH POP-OFF SUTURES CONTAINED 9 SUTURES, RATHER THAN 8.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607134 ↗
• MalfunctionDec 7, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE SUTURE BROKE OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10962376 ↗
• MalfunctionDec 11, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THE TIP OF THE NEEDLE WAS RETRIEVED. A SIMILAR DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9450269 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse 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 WAS DIAGNOSED WITH CELLULITIS ON AN UNKNOWN DATE. THE CURRENT PATIENT CONDITION IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Cellulitis

  MAUDE report 8307820 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse 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 WAS DIAGNOSED WITH CELLULITIS ON AN UNKNOWN DATE. THE CURRENT PATIENT CONDITION IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Cellulitis

  MAUDE report 8307768 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse 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 WAS DIAGNOSED WITH CELLULITIS ON AN UNKNOWN DATE. THE CURRENT PATIENT CONDITION IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Cellulitis

  MAUDE report 8307583 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse 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 WAS DIAGNOSED WITH CELLULITIS ON AN UNKNOWN DATE. THE CURRENT PATIENT CONDITION IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Cellulitis

  MAUDE report 8307464 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse 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 WAS DIAGNOSED WITH CELLULITIS ON AN UNKNOWN DATE. THE CURRENT PATIENT CONDITION IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Cellulitis

  MAUDE report 8307365 ↗