Coated VICRYL VCPP81DRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705031056886), received between Mar 27, 2019 and Apr 28, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING THE PATIENT WITH SUTURE, IT WAS FOUND THAT THE NEEDLE AND SUTURE CONNECTION WAS LOOSE AND EASY TO BREAK. STOP USING IT IMMEDIATELY. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920854 ↗
• MalfunctionMar 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL RESECTION OF INTRASPINAL TUMORS PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER FIVE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21636856 ↗
• MalfunctionMar 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL RESECTION OF INTRASPINAL TUMORS PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER FIVE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21636817 ↗
• MalfunctionMar 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL RESECTION OF INTRASPINAL TUMORS PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER FIVE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21636806 ↗
• MalfunctionMar 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL RESECTION OF INTRASPINAL TUMORS PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER FIVE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21636762 ↗
• MalfunctionMar 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL RESECTION OF INTRASPINAL TUMORS PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER FIVE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21636748 ↗
• MalfunctionMar 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL RESECTION OF INTRASPINAL TUMORS PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER FIVE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21636743 ↗
• MalfunctionJan 21, 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, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE LOT OF THE IP IS UNAVAILABLE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21202929 ↗
• MalfunctionJun 6, 2024Material Discolored; Device Contaminated During Manufacture or Shipping; Material Discolored; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. OXIDATION WAS FOUND ON THE NEWLY DISPENSED SUTURE WHEN PREPARING FOR SURGERY, AND THE COLOR WAS DIFFERENT FROM THAT OF THE NORMAL ONE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19478011 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6)2024 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER SIX SUTURE FROM THE SAME POUCH TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THE SEVEN ACTUAL SAMPLES WERE DISCARDED. THE SURGEON REFUSED TO USE ONE UNUSED SUTURE IN THE SAME POUCH. NO PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002951 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6)2024 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER SIX SUTURE FROM THE SAME POUCH TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THE SEVEN ACTUAL SAMPLES WERE DISCARDED. THE SURGEON REFUSED TO USE ONE UNUSED SUTURE IN THE SAME POUCH. NO PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002948 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTERECTOMY ON (B)(4). 2024 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER SIX SUTURE FROM THE SAME POUCH TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THE SEVEN ACTUAL SAMPLES WERE DISCARDED. THE SURGEON REFUSED TO USE ONE UNUSED SUTURE IN THE SAME POUCH. NO PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002946 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6)2024 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER SIX SUTURE FROM THE SAME POUCH TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THE SEVEN ACTUAL SAMPLES WERE DISCARDED. THE SURGEON REFUSED TO USE ONE UNUSED SUTURE IN THE SAME POUCH. NO PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002945 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER SIX SUTURE FROM THE SAME POUCH TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THE SEVEN ACTUAL SAMPLES WERE DISCARDED. THE SURGEON REFUSED TO USE ONE UNUSED SUTURE IN THE SAME POUCH. NO PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002944 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER SIX SUTURE FROM THE SAME POUCH TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THE SEVEN ACTUAL SAMPLES WERE DISCARDED. THE SURGEON REFUSED TO USE ONE UNUSED SUTURE IN THE SAME POUCH. NO PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002942 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER SIX SUTURE FROM THE SAME POUCH TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THE SEVEN ACTUAL SAMPLES WERE DISCARDED. THE SURGEON REFUSED TO USE ONE UNUSED SUTURE IN THE SAME POUCH. NO PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002941 ↗
• MalfunctionMar 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE FOR GYNECOLOGICAL TUMORS; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE WOUND . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894759 ↗
• MalfunctionSep 15, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A SURGERY DUE TO A PELVIC MASS (RIGHT OVARIAN CYST, LEFT FALLOPIAN TUBE HYDRONEPHROSIS, UTERINE CAVITY EFFUSION, DEGREE II UTERINE PROLAPSE, DEGREE II ANTERIOR VAGINAL WALL PROLAPSE, DEGREE II POSTERIOR VAGINAL WALL PROLAPSE, AND STRESS URINARY INCONTINENCE ON (B)(6) 2023 AND SUTURE WAS USED. WHEN THE DOCTOR SUTURED THE PATIENT, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761043 ↗
• MalfunctionSep 25, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE OFF IN THE PATIENT. BOTH PARTS OF THE NEEDLE WERE RETRIEVED FROM THE PATIENT. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9119237 ↗
• MalfunctionMar 27, 2019Break; Degraded; Tear, Rip or Hole in Device Packaging; Break; Degraded; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN HYSTERECTOMY SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8456494 ↗

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