Coated VICRYL VCP840DRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10705031055773), received between May 18, 2021 and Jan 20, 2026 — classified as 7 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (13 reports).

2 other recalls cover devices cleared under the same FDA submission (K032420, K132580, K181652); they may or may not involve this specific model.

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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT WHILE A PATIENT WAS UNDER THE SUTURE KEPT BREAKING WHEN THE SURGEON WAS WORKING THEIR WAY CLOSING UP THE SKIN. NEEDLE PULLS OFF SUTURE WHEN PASSING THROUGH TISSUE. NO PATIENT INJURY OR HARM HAS BEEN REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116016 ↗
• MalfunctionDec 4, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE SURGEON THAT ONE OF THEIR TECHS OPENED A SUTURE AND FOUND THERE TO BE WETNESS/MOISTURE INSIDE THE PACKAGING. WHEN HE RECEIVED THE PACKAGE, IT WAS NO LONGER WET BUT I FEEL THIS IS SOMETHING THAT YOU SHOULD BE AWARE OF. BELOW IS ADDITIONAL INFORMATION ABOUT THE SUTURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715174 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, ON THE FIRST PASS, THE SUTURE POPPED OFF THE NEEDLE BEFORE PASSING ALL THE WAY THROUGH THE TISSUE. ANOTHER SUTURE OF A DIFFERENT CODE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941333 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, ON THE FIRST PASS, THE SUTURE POPPED OFF THE NEEDLE BEFORE PASSING ALL THE WAY THROUGH THE TISSUE. ANOTHER SUTURE OF A DIFFERENT CODE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941332 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, ON THE FIRST PASS, THE SUTURE POPPED OFF THE NEEDLE BEFORE PASSING ALL THE WAY THROUGH THE TISSUE. ANOTHER SUTURE OF A DIFFERENT CODE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941330 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, ON THE FIRST PASS, THE SUTURE POPPED OFF THE NEEDLE BEFORE PASSING ALL THE WAY THROUGH THE TISSUE. ANOTHER SUTURE OF A DIFFERENT CODE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941323 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, ON THE FIRST PASS, THE SUTURE POPPED OFF THE NEEDLE BEFORE PASSING ALL THE WAY THROUGH THE TISSUE. ANOTHER SUTURE OF A DIFFERENT CODE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941183 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, ON THE FIRST PASS, THE SUTURE POPPED OFF THE NEEDLE BEFORE PASSING ALL THE WAY THROUGH THE TISSUE. ANOTHER SUTURE OF A DIFFERENT CODE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941182 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, ON THE FIRST PASS, THE SUTURE POPPED OFF THE NEEDLE BEFORE PASSING ALL THE WAY THROUGH THE TISSUE. ANOTHER SUTURE OF A DIFFERENT CODE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941180 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR DECOMPRESSION ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A SURGICAL SITE INFECTION. THE PATIENT HAD TO RETURN ABOUT A MONTH LATER TO HAVE THE INFECTION SURGICALLY REMOVED. THE CURRENT CONDITION OF THE PATIENT WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Impaired Healing; Unspecified Infection; Wound Dehiscence

  MAUDE report 21232742 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR DECOMPRESSION ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A SURGICAL SITE INFECTION. THE PATIENT RETURNED ON (B)(6) 2024 TO HAVE THE INFECTION SURGICALLY REMOVED. THE PATIENT WAS DOING WELL AS OF (B)(6) 2024 AND WAS STILL HAVING ANTIBIOTICS DISTRIBUTED FOR A WEEK AFTER DISCHARGE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Fever; Fluid Discharge; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 21232737 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR DECOMPRESSION ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A SURGICAL SITE INFECTION. THE PATIENT RETURNED ON (B)(6) 2024 TO HAVE THE INFECTION SURGICALLY REMOVED. THE PATIENT WAS DOING WELL AS OF 30-DEC-2024. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 21232733 ↗
• MalfunctionOct 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN USING SUTURE, IT WAS FOUND THAT THE SUTURE AND NEEDLE WERE NOT CONNECTED TIGHTLY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344787 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM #MW (B)(4), APPROXIMATELY 1-2 CM OF THE TIP OF A O VICRYL WAS OBSERVED BY THE SURGEON TO NOT BE ON THE END OF THE NEEDLE. HE HAD THROWN AN X-STITCH AND IT WAS NOT CLEAR WHETHER THE TIP WAS ORIGINALLY MISSING OR HAD BROKE OFF DURING ONE OF HIS THROWS WITH THE NEEDLE. THE WOUND WAS THOROUGHLY EXAMINED AND IRRIGATED. THE FLOOR WAS SEARCHED WITH THE MAGNET AS WELL AS THE DRAPES. RADIOLOGY WAS CALLED AND THEY PERFORMED A AP AND A LATERAL. SURGEON READ THE X-RAY AND STATED THAT HE SAW NO EVIDENCE OF A TIP OF A NEEDLE. SURGEON NOTIFIED THE FAMILY OF THE INCIDENT. THE DEVICE WAS NOT AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20086029 ↗
• MalfunctionAug 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEUROSURGERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING NEUROSURGERY; WHERE THE SUTURE WOULD BREAK /POP OFF WHILE STILL IN USE AND PUSHING THROUGH TISSUE. THE LOT NUMBER OF WHAT WAS USED INTRA OP IS THE SAME AS THE ONES BEING RETURNED. THERE WAS NO PATIENT CONSEQUENCES REPORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY. SURGICAL DELAY UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19961723 ↗
• MalfunctionAug 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEUROSURGERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING NEUROSURGERY; WHERE THE SUTURE WOULD BREAK /POP OFF WHILE STILL IN USE AND PUSHING THROUGH TISSUE. THE LOT NUMBER OF WHAT WAS USED INTRA OP IS THE SAME AS THE ONES BEING RETURNED. THERE WAS NO PATIENT CONSEQUENCES REPORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY. SURGICAL DELAY UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19961716 ↗
• MalfunctionJan 29, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN CLOSING THE ABDOMINAL INCISION AT END OF CASE, THE NEEDLE BROKE IN HALF. IT WAS NOTED AS SOON AS THE NEEDLE CAME THROUGH THE SKIN. THE SURGEON IMMEDIATELY LOOKED FOR THE NEEDLE BUT WAS UNABLE TO LOCATE IT. OBTAINED X-RAY TO VERIFY IN PATIENT'S ABDOMEN. THE NEEDLE WAS IDENTIFIED ON X-RAY IN THE ABDOMEN. THE NEEDLE WAS LOCATED AND REMOVED AFTER X-RAY CONFIRMATION AND EXPLORATION OF SITE. COUNTS AT END OF CASE WERE COMPLETED AND ACCURATE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER FOLLOW-UP COULD BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18594324 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2023 AND SUTURE WAS USED. AFTER THE SURGERY, THE PATIENT COMPLAINED OF INCISION PAIN WITHOUT OBVIOUS ABNORMALITIES. ONE WEEK LATER, THE PATIENT COMPLAINED OF PAIN AT THE RIGHT HIP WOUND WITH OBVIOUS FIXED TENDERNESS, LOCATED AT THE KNOT DURING THE RIGHT TOTAL HIP ARTHROPLASTY SURGERY. THE PATIENT EXPERIENCED POST-OP INFLAMMATION. THERE WAS NO SIGNIFICANT INCREASE IN BLOOD COUNT AND NO OBVIOUS ABNORMALITY WAS FOUND ON THE DR FILM. CONSIDERING THE SUTURE REJECTION REACTION, THE PATIENT'S PAIN SYMPTOMS WERE SIGNIFICANTLY RELIEVED AFTER ANTI-INFLAMMATORY TREATMENT WITH DEXAMETHASONE, AND RESIDUAL PAIN REMAINED AFTER DISCHARGE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Local Reaction; Pain

  MAUDE report 18273239 ↗
• MalfunctionAug 7, 2023Material 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 SALES REP REPORTED THAT THE NEEDLE KEPT POPPING OFF SUTURE WITHOUT PRESSURE. NEW SUTURE WAS USED TO COMPLETE PROCEDURE. THERE WAS NO DELAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477290 ↗
• MalfunctionAug 7, 2023Material 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 SALES REP REPORTED THAT THE NEEDLE KEPT POPPING OFF SUTURE WITHOUT PRESSURE. NEW SUTURE WAS USED TO COMPLETE PROCEDURE. THERE WAS NO DELAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477289 ↗
• InjuryAug 2, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR 4-LUMBAR 5 POSTERIOR SPINAL INSTRUMENTED FUSION AND DECOMPRESSION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST OP THE SUTURES WERE NOT DISSOLVING AND WERE BEING REJECTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Bacterial Infection; Discomfort; Fluid Discharge; Impaired Healing; Pocket Erosion; Wound Dehiscence

  MAUDE report 17440516 ↗
• InjuryAug 1, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR 4-LUMBAR 5 POSTERIOR SPINAL INSTRUMENTED FUSION AND DECOMPRESSION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST OP THE SUTURES WERE NOT DISSOLVING AND WERE BEING REJECTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Fluid Discharge; Inflammation; Pocket Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 17439549 ↗
• MalfunctionMay 5, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN A & P REPAIR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE A & P REPAIR THE SURGEON USED THE SUTURE AND AFTER USING IT HANDED IT BACK TO THE SCRUB WITH THE NEEDLE CLOSED IN THE NEEDLE DRIVER. WHEN THE SCRUB RELEASED THE NEEDLE THE TIP WAS BROKEN OFF. THIS DID NOT HAPPEN IN THE PATIENT BUT AFTER USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875476 ↗
• MalfunctionJan 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THA OR TKA PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE CUSTOMER HAD AN INSTANCE OF SUTURE NEEDLE TIPS BREAKING OFF DURING A CASE. IN ONE CASE, THE TIP WAS RETAINED DURING A TKA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183497 ↗
• MalfunctionJan 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THA OR TKA PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE,IT WAS REPORTED BY THE DISTRIBUTOR THAT THE CUSTOMER HAD AN INSTANCE OF SUTURE NEEDLE TIPS BREAKING OFF DURING A CASE. IN ONE CASE, THE TIP WAS RETAINED DURING A TKA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183495 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032420, K132580, K181652. One submission often covers many models, so check the product and lot details in each record.

• Z-2145-2024 · May 10, 2024 · Open, Classified
  VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological
• Z-1310-2009 · Feb 2, 2009 · Terminated
  Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and