Coated VICRYL VCP303HRecalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 10705031052093), received between May 6, 2019 and Sep 1, 2026 — classified as 1 injury, 117 malfunctions.

The most frequently reported specific device problem is “Material Separation” (89 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 118 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50541813 ↗
• MalfunctionJul 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50053052 ↗
• MalfunctionMay 21, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEAD AND FACIAL SKIN TUMOR RESECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT DUE TO A SKIN MASS ON THE HEAD AND FACE. FOLLOWING THE DOCTOR'S ADVICE, THE PATIENT UNDERWENT HEAD SURGERY. DURING TREATMENT, THE DOCTOR FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE DOCTOR IMMEDIATELY SUSPENDED THE SURGERY, CHANGED THE SUTURE, AND COMFORTED THE PATIENT. AFTER TREATMENT, THE PATIENT WAS TREATED AND OBSERVED TO BE IN GOOD CONDITION. AFTER EXAMINATION, THE HOSPITAL BELIEVES THAT THE OCCURRENCE OF THIS MALFUNCTION IS DUE TO THE LOOSE CONNECTION POINT OF THE NEEDLE AND SUTURE, RESULTING IN A DEVIATION IN THE QUALITY OF THE THREAD BODY. ALTHOUGH THE MALFUNCTION DID NOT CAUSE ANY PHYSICAL HARM TO THE PATIENT, IT RESULTED IN AN EXTENDED SURGICAL TIME AND REQUIRED THE REPLACEMENT OF NEW SUTURE TO COMPLETE THE SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250297 ↗
• MalfunctionApr 29, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPERFICIAL TUMOR RESECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT AND WAS DIAGNOSED WITH A "SKIN MASS" AND UNDERWENT SURGERY. AFTER REMOVING THE TUMOR, THE DOCTOR SUTURED THE SKIN. WHEN SEWING THE SECOND STITCH, WHEN THE NEEDLE PASSED THROUGH THE SKIN AND PULLED THE NEEDLE NORMALLY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, WHICH MADE IT UNUSABLE. STOPPED USING IT IMMEDIATELY AND REPLACED IT WITH A NEW SUTURE OF THE SAME ORIGIN, BATCH NUMBER AND MODEL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034758 ↗
• MalfunctionApr 21, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, 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 24944258 ↗
• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. 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 CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. 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 24928053 ↗
• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. 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 CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. 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 24928052 ↗
• MalfunctionApr 13, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON SEWED THE PATIENT, THE SUTURE AUTOMATICALLY BROKE AND A NEW SUTURE WAS IMMEDIATELY REPLACED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865182 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THIS MORNING AFTER THE PATIENT'S TOOTH EXTRACTION, THE SUTURE BROKE DURING SUTURING. RE SUTURED THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24720073 ↗
• MalfunctionMar 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AT 10:50, THE DOCTOR REMOVED A FACIAL TUMOR FROM THE PATIENT AND USED A SMALL NEEDLE HOLDER AND SUTURE TO SUTURE IT. WHEN THE FIRST STITCH WAS INSERTED THROUGH THE TISSUE FOR TISSUE PUNCTURE, IT WAS FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE DOCTOR IMMEDIATELY MANUALLY TIED THE KNOT AND CUT OFF THE SUTURE, REPLACING IT WITH ANOTHER SUTURE FOR NORMAL SUTURING. AT THE SAME TIME, THE NURSE RETAINED THE PROBLEM SUTURE AND OUTER PACKAGING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705811 ↗
• MalfunctionFeb 25, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN TUMOR RESECTION SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE DOCTOR WAS PREPARING TO SUTURE THE SKIN WITH SUTURE AFTER REMOVING THE TUMOR, IT WAS FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND COULD NOT BE USED. IMMEDIATELY STOPPED USING AND REPLACED WITH NEW SUTURE OF THE SAME ORIGIN, BATCH NUMBER, AND MODEL. IN SUBSEQUENT OPERATIONS, SIMILAR PROBLEM OCCURRED AGAIN WITH PRODUCT OF THE SAME BATCH NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442029 ↗
• MalfunctionFeb 25, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN TUMOR RESECTION SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE DOCTOR WAS PREPARING TO SUTURE THE SKIN WITH SUTURE AFTER REMOVING THE TUMOR, IT WAS FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND COULD NOT BE USED. IMMEDIATELY STOPPED USING AND REPLACED WITH NEW SUTURE OF THE SAME ORIGIN, BATCH NUMBER, AND MODEL. IN SUBSEQUENT OPERATIONS, SIMILAR PROBLEM OCCURRED AGAIN WITH PRODUCT OF THE SAME BATCH NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442027 ↗
• MalfunctionFeb 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 12:53, WHEN THE DOCTOR USED SUTURE TO DEBRIDE AND SEW THE PATIENT'S WOUND, IT WAS FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND UNABLE TO BE USED. IMMEDIATELY REPLACED WITH A NEW SUTURE OF THE SAME MODEL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24334384 ↗
• MalfunctionJan 22, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. NEEDLE PULL OFF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WAS NO SIGNIFICANT DELAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147904 ↗
• MalfunctionJan 16, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE-SUTURE HAD BEEN DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24099669 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073409 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073408 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073407 ↗
• MalfunctionJan 7, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE DETACHMENT FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995984 ↗
• MalfunctionJan 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979876 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT CAME TO THE HOSPITAL FOR DIAGNOSIS OF A "SKIN MASS" AND REQUIRED SURGICAL RESECTION. AFTER REMOVING THE MASS, THE DOCTOR SUTURED THE SKIN. WHEN THE FIRST STITCH WAS SUTURED, THE NEEDLE PASSED THROUGH THE SKIN AND WAS PULLED NORMALLY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND COULD NOT BE USED. IMMEDIATELY STOP USING AND REPLACE WITH NEW SUTURE OF THE SAME ORIGIN, BATCH NUMBER, AND MODEL. IN SUBSEQUENT OPERATIONS, NO SIMILAR ISSUE WAS FOUND WITH THE SAME BATCH OF PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888915 ↗
• MalfunctionNov 26, 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, THE SUTURE PULLED OFF THE NEEDLE UPON REMOVAL FROM THE PACKAGE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. UPON EVALUATION OF THE RETURNED DEVICE, SHORT INSERTION ISSUE WAS IDENTIFIED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657952 ↗
• InjuryNov 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. THE INTESTINAL TUBE WAS ADHESIVELY CONNECTED TO THE UTERUS DURING SURGERY. AFTER SEPARATION OF THE ADHESIONS, THERE WAS DAMAGE TO THE SEROSAL SURFACE OF THE INTESTINAL TUBE, AND IT WAS PREPARED TO BE SUTURED WITH SUTURE. DURING THE PROCESS OF ENTERING THE ABDOMEN, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND THE NEEDLE COULD NOT BE FOUND. THEREFORE, THE PROCEDURE HAD TO BE SWITCHED TO OPEN SURGERY HALFWAY, AND FINALLY THE NEEDLE WAS FOUND UNDER THE SKIN. EXTENDED THE SURGERY TIME AND INCREASED THE PATIENT'S PAIN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain

  MAUDE report 23544112 ↗
• MalfunctionOct 15, 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, NEEDLE DETACHING FROM SWAGE, AT LEAST 5 IMPACTED PIECES AND USERS RETURNED REMAINING BOX FOR INVESTIGATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23283066 ↗
• MalfunctionOct 15, 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, NEEDLE DETACHING FROM SWAGE, AT LEAST 5 IMPACTED PIECES AND USERS RETURNED REMAINING BOX FOR INVESTIGATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23282293 ↗

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