Coated VICRYL J947HRecalls & reported problems

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 10705031043688), received between Jun 10, 2019 and Jul 23, 2025 — classified as 139 malfunctions.

The most frequently reported specific device problem is “Material Separation” (117 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 25 most recent of 139 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP, THAT DURING HERNIA REPAIR, THE NEEDLE IS POPPING OFF THE SUTURE WHEN IT SHOULDN'T HAVE BEEN. THERE WE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579302 ↗
• MalfunctionJul 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP, THAT DURING HERNIA REPAIR, THE NEEDLE IS POPPING OFF THE SUTURE WHEN IT SHOULDN'T HAVE BEEN. THERE WE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579266 ↗
• MalfunctionJul 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP, THAT DURING HERNIA REPAIR, THE NEEDLE IS POPPING OFF THE SUTURE WHEN IT SHOULDN'T HAVE BEEN. THERE WE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579265 ↗
• MalfunctionJul 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP, THAT DURING HERNIA REPAIR, THE NEEDLE IS POPPING OFF THE SUTURE WHEN IT SHOULDN'T HAVE BEEN. THERE WE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579251 ↗
• MalfunctionJul 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP, THAT DURING HERNIA REPAIR, THE NEEDLE IS POPPING OFF THE SUTURE WHEN IT SHOULDN'T HAVE BEEN. THERE WE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579232 ↗
• MalfunctionJul 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING HERNIA REPAIR, THE NEEDLE IS POPPING OFF THE SUTURE WHEN IT SHOULDN'T HAVE BEEN. THERE WE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579224 ↗
• MalfunctionApr 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE IN THE BOX POPPED OFF THE SUTURE. THERE WAS NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21747705 ↗
• MalfunctionApr 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE IN THE BOX POPPED OFF THE SUTURE. THERE WAS NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21747700 ↗
• MalfunctionJan 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE AND IT WAS NOT CONTROL RELEASE. CASE COMPLETED WITH A LIKE DEVICE WITH A DIFFERENT LOT NUMBER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152397 ↗
• MalfunctionJan 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE AND IT WAS NOT CONTROL RELEASE. CASE COMPLETED WITH A LIKE DEVICE WITH A DIFFERENT LOT NUMBER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152394 ↗
• MalfunctionJan 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE AND IT WAS NOT CONTROL RELEASE. CASE COMPLETED WITH A LIKE DEVICE WITH A DIFFERENT LOT NUMBER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152392 ↗
• MalfunctionJan 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE AND IT WAS NOT CONTROL RELEASE. CASE COMPLETED WITH A LIKE DEVICE WITH A DIFFERENT LOT NUMBER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152390 ↗
• MalfunctionJan 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE AND IT WAS NOT CONTROL RELEASE. CASE COMPLETED WITH A LIKE DEVICE WITH A DIFFERENT LOT NUMBER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152389 ↗
• MalfunctionJan 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE AND IT WAS NOT CONTROL RELEASE. CASE COMPLETED WITH A LIKE DEVICE WITH A DIFFERENT LOT NUMBER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152388 ↗
• MalfunctionNov 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. THE NEEDLE WAS RETRIEVED AND THE CASE WAS COMPLETED WITH A SUTURE FROM A DIFFERENT LOT NUMBER WITHOUT PATIENT HARM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786473 ↗
• MalfunctionNov 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. THE NEEDLE WAS RETRIEVED AND THE CASE WAS COMPLETED WITH A SUTURE FROM A DIFFERENT LOT NUMBER WITHOUT PATIENT HARM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784631 ↗
• MalfunctionNov 5, 2024

  SUTURE NEEDLE PULLS OFF LIKE A POP-OFF NEEDLE SHOULD. THIS SHOULD NOT HAPPEN WITH THIS TYPE OF SUTURE. THE SURGEON REQUESTED THIS TO BE DOCUMENTED AND REPORTED AS THIS HAD ALSO HAPPENED IN THE PAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609598 ↗
• MalfunctionOct 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE NEEDLES WERE POPPING OFF OF THE SUTURE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20401434 ↗
• MalfunctionOct 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE NEEDLES WERE POPPING OFF OF THE SUTURE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20401371 ↗
• MalfunctionOct 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE NEEDLES WERE POPPING OFF OF THE SUTURE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20399012 ↗
• MalfunctionOct 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE NEEDLES WERE POPPING OFF OF THE SUTURE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20398990 ↗
• MalfunctionSep 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED TO THE SALES REP BY THE SURGEON WAS INFORMED OF NEEDLES POPPING OFF OF SUTURE FROM THE SAME BOX WITH LITTLE TO NO FORCE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2024 AND STATED THAT "WE OPENED A NEW BOX ONE DAY AND THE SURGEON STARTED USING IT AND THE NEEDLE JUST POPS OFF WITHOUT MUCH FORCE. EVEN LOADING THE SUTURE I HAD ONE POP OFF". THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20215014 ↗
• MalfunctionSep 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED TO THE SALES REP BY THE SURGEON WAS INFORMED OF NEEDLES POPPING OFF OF SUTURE FROM THE SAME BOX WITH LITTLE TO NO FORCE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2024 AND STATED THAT "WE OPENED A NEW BOX ONE DAY AND THE SURGEON STARTED USING IT AND THE NEEDLE JUST POPS OFF WITHOUT MUCH FORCE. EVEN LOADING THE SUTURE I HAD ONE POP OFF". THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20214999 ↗
• MalfunctionSep 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED TO THE SALES REP BY THE SURGEON WAS INFORMED OF NEEDLES POPPING OFF OF SUTURE FROM THE SAME BOX WITH LITTLE TO NO FORCE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2024 AND STATED THAT "WE OPENED A NEW BOX ONE DAY AND THE SURGEON STARTED USING IT AND THE NEEDLE JUST POPS OFF WITHOUT MUCH FORCE. EVEN LOADING THE SUTURE I HAD ONE POP OFF". THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20213690 ↗
• MalfunctionSep 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES IN THE BOX WERE "POPPING OFF" LIKE CONTROLLED RELEASE SUTURE, WHICH THEY ARE NOT DESIGNED TO BE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20193927 ↗