Coated VICRYL J270HRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705031038455), received between Apr 9, 2019 and Dec 31, 2024 — classified as 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SURGEON WAS SUTURING WITH NEEDLE AND AFTER A FEW PASSES SUTURE (NEEDLE) BROKE IN TWO PIECES NEEDLE WAS PROMPTLY TAKEN OFF FIELD AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047618 ↗
• MalfunctionDec 5, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853150 ↗
• MalfunctionMar 14, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING UNKNOWN TISSUE THE NEEDLE BROKE. FRAGMENT WAS RETRIEVED. UNKNOWN IF AN X-RAY WAS NEEDED. ANOTHER LIKE DEVICE WAS USED TO CONTINUE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542650 ↗
• MalfunctionOct 29, 2022Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15696031 ↗
• MalfunctionOct 29, 2022Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15695763 ↗
• MalfunctionOct 29, 2022Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15695012 ↗
• MalfunctionOct 28, 2022Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15693486 ↗
• MalfunctionOct 28, 2022Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692289 ↗
• MalfunctionOct 16, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN WOUND CLOSURE PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUTURE PACK WAS OPENED AND PRODUCT OF OTHER CODE WAS FOUND INSIDE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10689916 ↗
• MalfunctionFeb 19, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. WHILE CLOSING THE UMBILICAL FASCIA, UNKNOWN LOOP, AND THE NEEDLE BROKE IN HALF WHILE SUTURING. X-RAY WAS PERFORMED TO LOCATE AND RETRIEVE THE BROKEN PIECES. ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. ADDITIONAL SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9729606 ↗
• MalfunctionJun 13, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GENSLING, LAPAROSCOPIC PORT SITE PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING CLOSURE THE SUTURE MATERIAL BROKE WHEN ATTEMPTED TO HAND TIE. NO ADVERSE PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8697671 ↗
• MalfunctionJun 13, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GENSLING, LAPAROSCOPIC PORT SITE PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING CLOSURE THE SUTURE MATERIAL BROKE WHEN ATTEMPTED TO HAND TIE. NO ADVERSE PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8697668 ↗
• MalfunctionJun 13, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GENSLING, LAPAROSCOPIC PORT SITE PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING CLOSURE THE SUTURE MATERIAL BROKE WHEN ATTEMPTED TO HAND TIE. NO ADVERSE PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8697637 ↗
• MalfunctionJun 4, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE IN 2019 AND SUTURE WAS USED. THE NEEDLE BROKE DURING CLOSURE OF THE FASCIA. THE TIP BROKE IN AROUND 2CM IN LENGTH. ALL PIECES OF THE NEEDLE WERE RETRIEVED DURING THE PROCEDURE AND NO X-RAY WAS NEEDED. THE SURGEON OPINED THAT A CONTRIBUTING FACTOR TO THE EFFORTS PLACED ON THE NEEDLE USED IN CLOSURE WAS THAT THE PATIENT WAS OBESE AND DIFFICULT TO CLOSE THE FASCIA. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8668411 ↗
• MalfunctionApr 9, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF INSIDE THE PATIENT DURING SURGERY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8496732 ↗