Coated VICRYL VCP304H (UDI 10705031149748)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031149748), received between Apr 1, 2025 and Aug 6, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50157500 ↗
• MalfunctionAug 6, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50157495 ↗
• MalfunctionJul 31, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50101220 ↗
• MalfunctionJul 30, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50083643 ↗
• MalfunctionJul 30, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50083635 ↗
• MalfunctionJul 30, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50083628 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE THREAD HAS BROKEN SEVERAL TIMES AT THE REINFORCEMENT ZONE. THERE WERE NO SIGNIFICANT DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044518 ↗
• MalfunctionMar 4, 2026Device Contaminated During Manufacture or Shipping; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BODY HAD RUSTED WHEN JUST OPEN THE PACKAGE. 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 24512917 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem; Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL MASTECTOMY FOR BREAST CANCER ON (B)(6) 2026 AND SUTURE WAS USED TO CLOSE THE INCISION. ON THE 8TH DAY AFTER SURGERY, THE PATIENT SHOWED POOR WOUND HEALING, LOCAL SKIN REDNESS AND SWELLING, WHITE SKIN EDGE COLOR, AND VISIBLE EXUDATE UNDER COMPRESSION. AFTER ACTIVE DRESSING CHANGES AND CONSERVATIVE TREATMENT UNTIL THE 11TH DAY AFTER SURGERY, THERE WAS NO SIGNIFICANT IMPROVEMENT IN THE WOUND CONDITION, AND DEBRIDEMENT AND SUTURING SURGERY WERE PERFORMED. THE DOCTOR FOUND DURING THE SURGERY THAT THE ABOVE-MENTIONED SUTURE WAS NOT ABSORBED IN THE BODY AND WAS REMOVED. BASED ON COMPREHENSIVE CLINICAL PROCESS ANALYSIS, CONSIDERED THE CORRELATION BETWEEN POOR WOUND HEALING AND POOR SUTURE SUCTION IN THE PATIENT. STRENGTHEN INCISION CARE AND OBSERVATION AFTER SURGERY TO ENSURE THE HEALING PROCESS AFTER SECONDARY SUTURING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Skin Discoloration; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 24323402 ↗
• MalfunctionSep 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURES BREAK WHEN PULLED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23142186 ↗
• MalfunctionJun 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. IMMEDIATELY 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 22161589 ↗
• MalfunctionMay 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE SURGICAL SUTURING PROCESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. IMMEDIATELY CHANGED ANOTHER ONE FOR SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036494 ↗
• InjuryApr 1, 2025Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A ROBOTIC PROSTATECTOMY PROCEDURE DONE ON (B)(6)2025 AND SUTURE WAS USED. THE NEEDLE POPPED OFF OF THE SUTURE AND WAS LOST INSIDE THE PATIENT. DEVICE IS NOT AVAILABLE FOR RETURN. THE NEEDLE IS VISIBLE ON AN X-RAY BUT WERE UNABLE TO LOCATE IN THE PATIENT WITHOUT OPENING UP THE PATIENT WITH ABDOMINAL INCISION. THE NEEDLE RETAINED IN THE LOWER ABDOMINAL AREA NEEDLE WAS AN RB-1, 17MM HALF CIRCLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21742468 ↗