Coated VICRYL J840DRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031043237), received between Aug 23, 2019 and Nov 14, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. A SURGICAL TECH OPENED UP A PACK OF SUTURE AND THERE WAS WHAT APPEARED TO BE A BLACK HAIR IN THE SWAGE OF THE NEEDLE. THE PACK OF SUTURE WAS PLACED TO THE SIDE OF THE FIELD AND A NEW PACK OF SUTURES WAS OPENED. THERE WAS NO DIRECT IMPACT TO PATIENT OR PROCEDURE AND NO NEEDLES OR SUTURE WERE REMOVED FROM THE PACK. NO DELAYS. NO FRAGMENTS MADE. NO PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132162 ↗
• InjuryApr 19, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE FRAGMENTED AND WAS CLOSED WITHIN THE ABDOMEN OF THE PATIENT. CONFIRMED BY XRAY. AT SOME POINT THE PATIENT WILL BE RE OPENED AND THE FRAGMENT REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16768827 ↗
• MalfunctionJul 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE POP OFF SUTURES WERE POPPING OFF TO SOON. NOT WHEN THEY SHOULD. THEY OPENED A FEW. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008378 ↗
• MalfunctionNov 10, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE THE NEEDLES ARE POPPING OF THE CONTROLLED RELEASE TOO EASY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790786 ↗
• MalfunctionMay 26, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THE NEEDLE WAS RETRIEVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11889359 ↗
• MalfunctionSep 27, 2019Break; Break

  IT WAS REPORTED VIA USER FACILITY MEDWATCH FORM (B)(4) THAT THE PATIENT UNDERWENT LAPAROSCOPIC TOTAL HYSTERECTOMY AND BILATERAL LAPAROSCOPIC SALPINGECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS NOTICED THE NEEDLE HAD A NEEDLE TIP MISSING. UPON SEARCHING THE FLOOR, THE NEEDLE PIECE WAS FOUND. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131483 ↗
• MalfunctionSep 27, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED VIA USER FACILITY MEDWATCH FORM (B)(4) THAT THE PATIENT UNDERWENT LAPAROSCOPIC TOTAL HYSTERECTOMY AND BILATERAL LAPAROSCOPIC SALPINGECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN PUTTING IN THE FINAL STITCH TO CLOSE THE VAGINAL CUFF, THE NEEDLE BEING RETURNED WAS MISSING THE PIECE WHERE SUTURE IS SWEDGED ON. THE PHYSICIAN WAS CONSULTED AFTER SURGEON EXAMINED THE VAGINAL TISSUE AND COULD NOT FIND MISSING PIECE. THE NEEDLE PULLED THROUGH EASILY AND WAS CONSIDERED NOT LIKELY TO BE IN THE TISSUE. X-RAY WAS PERFORMED. UPON SEARCHING THE FLOOR THE NEEDLE WAS FOUND. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131476 ↗
• MalfunctionAug 23, 2019Detachment of Device or Device Component

  PUTTING IN THE FINAL STITCH TO CLOSE THE VAGINAL CUFF THE POP OFF NEEDLE BEING RETURNED WAS MISSING THE END PIECE (WHERE SUTURE IS SWEDGED ON). (0 VICRYL CT-1 J840D LOT # PMB943 EXP 2/29/2024) DOCTOR CAME TO CONSULT AFTER SURGEON EXAMINED THE VAGINAL TISSUE AND COULD NOT FIND MISSING PIECE. THE NEEDLE PULLED THROUGH EASILY AND WAS CONSIDERED NOT LIKELY TO BE IN THE TISSUE, X-RAY WAS CALLED. THEN IT WAS NOTICED ONE OF THE OTHER NEEDLES HAD A NEEDLE TIP MISSING. SEARCHING THE FLOOR BOTH PIECES WERE FOUND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8925991 ↗