Coated VICRYL J775DRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031042933), received between Apr 13, 2018 and May 13, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE IN PATIENT'S SKULL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010302 ↗
• MalfunctionDec 11, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGICAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN UROLOGICAL SURGERY, WHEN THE NEEDLE WAS APPLIED TO THE FASCIA DURING THE WOUND CLOSURE, THE NEEDLE WAS BROKEN AT THE SWAGE PART. IT HAD NOT FALLEN INSIDE THE BODY, BUT THE BROKEN PIECE OF THE NEEDLE COULD NOT BE FOUND IN THE OPERATING ROOM. IT IS ESTIMATED THAT THE REASON FOR THE BROKEN NEEDLE WAS BECAUSE EXCESSIVE FORCE WAS APPLIED TO THE SWAGE PART. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20908489 ↗
• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS FOUND THAT THE NEEDLE WAS BROKEN BEFORE USE. NO PIECES FELL INTO THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. PRODUCT WAS RETURNED AND EVALUATED AND FOUND BROKEN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179345 ↗
• MalfunctionDec 29, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON 05-DEC-2023 AND SUTURE WAS USED. THE NEEDLE TIP WAS BROKEN DURING INTERRUPTED SUTURE ON UTERUS. NO NEEDLE FRAGMENTS FELL INTO THE BODY DUE TO NEEDLE BREAKAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418640 ↗
• MalfunctionOct 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLPOCLEISIS PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING USE ON THE PATIENT THE NEEDLE BROKE IN HALF AND WAS FLUNG FROM STERILE FIELD. UNABLE TO FIND PART OF NEEDLE ON SURGICAL FIELD, DRAPES OR ON THE FLOOR WITH A MAGNET. CALLED X-RAY FOR PELVIC X-RAY. THIS WAS PERFORMED AND RADIOLOGY CALLED SHORTLY AFTER TO CONFIRM NO FOREIGN BODY IN THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17944239 ↗
• MalfunctionJun 28, 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 TIP WAS FRAGILE. THE NEEDLE TIP BROKE EASILY, COULD NOT BE LOCATED, AND THE WOUND WAS CLOSED WITH THE POSSIBILITY OF REMAINING IN THE PATIENT'S BODY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17217985 ↗
• MalfunctionJan 12, 2023Material Discolored; Material Integrity Problem; Material Discolored; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL FOR A CHECKUP ON DECEMBER 19. PHOTOGRAPH OF THE VAGINA WAS TAKEN. IMAGES WERE TAKEN THAT APPEARED TO BE SLIGHTLY BLUE IN COLOR AND WITH SOME SUTURES REMAINING. THOUGHT TO BE A REMNANT OF THE SUTURE USED FOR LIGATION OF THE CARDINAL LIGAMENT OR HEMOSTASIS. THE PATIENT WAS NOT NOTIFIED BECAUSE THE PATIENT HAD NO COMPLAINT SUCH AS STRANGE FEELING. THE SURGEON INFORMED SALES REP JUST FOR INFORMATION, AND THERE IS NO PARTICULAR REQUEST FOR ADDITIONAL ACTION. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16146618 ↗
• MalfunctionApr 25, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE PACKAGE DID NOT HAVE SUTURE INFORMATION ON THE TRAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193862 ↗
• MalfunctionApr 25, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE PACKAGE DID NOT HAVE SUTURE INFORMATION ON THE TRAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193858 ↗
• 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 NEEDLE BROKE OFF. FRAGMENTS WERE GENERATED SO AN X-RAY WAS PERFORMED TO ENSURE THE NEEDLE WAS NOT IN THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10962412 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEUROSURGERY PROCEDURE IN 2020 AND THE SUTURE WAS USED. POST-OPERATIVE, THE PATIENT EXPERIENCED WOUND DEHISCENCE AND WAS RE-SUTURED ON (B)(6) 2020. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 10760375 ↗
• InjuryApr 13, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR AND POSTERIOR REPAIR COLEPECTOMY PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE IN HALF . THE NEEDLE WAS BROKEN IN THE SOFT TISSUE WHERE THE SURGEON WAS BRINGING THE MUSCLE BACK TOGETHER. THE NEEDLE STAYED IN THE SOFT TISSUE WHERE IT BROKE OFF. X-RAY WAS BROUGHT IN. THE SURGEON HAD TO CUT AWAY SOFT TISSUE WHERE NEEDLE WAS BROKEN OFF AND THEN APPROXIMATE SOFT TISSUE BACK TOGETHER . THE BROKEN PART WAS RETRIEVED. IT WAS UNKNOWN IF THE PROCEDURE WAS OPEN OR LAPAROSCOPIC, SO IT WAS UNKNOWN IF THE NEEDLE WAS RETRIEVED LAPAROSCOPICALLY. THE TOTAL TIME TO LOCATE BROKEN NEEDLE WAS 2 HOURS. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7431278 ↗