Coated VICRYL VCP422H (UDI 10705031053090)Recalls & reported problems

Summary

The FDA's MAUDE database contains 176 adverse event reports that list this exact device (DI 10705031053090), received between Aug 1, 2018 and Sep 28, 2026 — classified as 15 injuries, 161 malfunctions.

The most frequently reported specific device problem is “Material Separation” (88 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 176 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923061 ↗
• MalfunctionSep 24, 2026Device Contaminated During Manufacture or Shipping

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026, and suture was used. When the doctor opened the package, he found that the suture was moldy. The doctor replaced the suture for use. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882426 ↗
• MalfunctionSep 14, 2026Break; Material Frayed

  It was reported that a patient underwent a c-section on (b)(6) 2026 and suture was used. During the procedure, when suturing the skin, the suture showed drawing, thinning and breakage, which was immediately reported to the head nurse. The broken end was cut flat and discarded. There were no adverse patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752074 ↗
• MalfunctionAug 12, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224647 ↗
• MalfunctionAug 5, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50146543 ↗
• MalfunctionJun 17, 2026Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THERE WAS ONE PACKAGE OF PRODUCT LESS THAN EXPECTED IN THE BOX DURING CHECKING. THERE SHOULD BE THIRTY-SIX PACKAGE OF PRODUCTS IN THE BOX, BUT ACTUALLY THERE WERE ONLY THIRTY-FIVE PACKAGE OF PRODUCTS. NOT INVOLVED IN ANY SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25540523 ↗
• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE STITCHES BROKE NEEDLE AND THREAD BREAK EASILY AFTER SEWING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364112 ↗
• MalfunctionMay 18, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE INCISION WAS SUTURED INTRADERMALLY AND THE SUTURE WAS DRAWN. THE DOCTOR REMOVED THE PROBLEMATIC SUTURE. REPLACED THE SUTURE AND RE SUTURED IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203352 ↗
• MalfunctionApr 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 11:22, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING SURGERY, AND THE USE WAS IMMEDIATELY STOPPED. A NEW SUTURE WAS REPLACED TO CONTINUE SUTURING, WHICH DELAYED THE SURGERY TIME AND POSED A SAFETY HAZARD TO THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873540 ↗
• MalfunctionApr 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE INTEGRITY AND EXPIRATION DATE OF THE OUTER PACKAGING OF THE SUTURE WERE CHECKED BEFORE SURGERY. AFTER CONFIRMING THAT THERE WERE NO ERRORS, THE SUTURE WAS OPENED AND HELD WITH A NEEDLE HOLDER. DURING THE SURGERY, THE DOCTOR FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHILE SUTURING THE SURFACE OF THE SKIN. THE OPERATION WAS IMMEDIATELY STOPPED AND NEW SUTURE WAS USED TO CONTINUE SUTURING, WHICH DELAYED THE OPERATION TIME AND POSED A SAFETY HAZARD TO THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872553 ↗
• MalfunctionJan 28, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AT 15:20, WHILE SEWING THE SKIN, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE DOCTOR IMMEDIATELY CHECKED THE INTEGRITY OF THE NEEDLE AND SUTURE, CHECKED WITH THE TRAVELING NURSE TO ENSURE THAT IT WAS INTACT, REPLACED THE SUTURE, AND CONTINUED THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205565 ↗
• MalfunctionJan 23, 2026Material 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. 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 24160286 ↗
• MalfunctionDec 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. WHEN THE DOCTOR TOOK THE SUTURE WITH THE NEEDLE HOLDER DURING THE SUTURE PROCESS, THE NEEDLE PULL OFF ISSUE HAPPENED AT THE THIRD STITCH, AND THE SUTURE WAS IMMEDIATELY REPLACED FOR SUTURE, WHICH PROLONGED THE OPERATION TIME AND INCREASED THE OPERATION RISK. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898749 ↗
• InjuryDec 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUTURE OF PERINEAL LACERATION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE BROKE DURING SEWING THE LATERAL EPISIOTOMY. THE BROKEN NEEDLE FELL INTO THE PATIENT, AND THE PATIENT WAS PUSHED FROM THE DELIVERY ROOM TO THE OPERATING ROOM. THE SEWED WOUND WAS REOPENED LAYER BY LAYER AND THE NEEDLE WAS FOUND WITH THE HELP OF THE C-ARM MACHINE. THE BROKEN NEEDLE WAS RETRIEVED FINALLY AND THERE WAS NO MASSIVE HEMORRHAGE. THE PATIENT IS FINE NOW. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23887934 ↗
• MalfunctionDec 18, 2025Product Quality Problem; Material Separation; Product Quality Problem; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE CORRECT USE ACCORDING TO THE INSTRUCTIONS, IT WAS FOUND THAT THERE WAS A ROLLED SUTURE AT THE CONTACT BETWEEN THE SUTURE END AND THE NEEDLE, WHICH WAS SUSPECTED TO BE CAUSED BY THE DETACHMENT OF THE SUTURE. STOP THE OPERATION IMMEDIATELY AFTER DISCOVERING THE ROLLED SUTURE AND REPLACE IT WITH A NEW SUTURE OF THE SAME MODEL FOR SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843272 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE LOT OF IP IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838548 ↗
• MalfunctionNov 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, UPON BITING SUBCUTANEOUS TISSUE AND TWISTING THE NEEDLE, NEEDLE SUDDENLY DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522830 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT UNDERWENT SURGERY AT OUR HOSPITAL FROM 14:22 TO 15:00. AT 14:50, WHEN SUTURING THE SKIN INCISION, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. IMMEDIATELY REPLACED THE SUTURE AND NO FURTHER BREAKAGE OCCURRED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304300 ↗
• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009892 ↗
• MalfunctionJun 5, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, 2D DATA MATRIX BARCODES COULD NOT BE SCANNED. IT'S REPORTED THAT 2D DATA MATRIX BARCODES ON THE PACKAGE COULD NOT BE SCANNED WHICH MAKE TROUBLE ON CUSTOMER'S WAREHOUSING WORK. AS THEY MANAGE PRODUCT ON PACKAGE LEVEL. AND THEY FEEDBACK THE TEXT ON THE PACKAGE IS NOT ENOUGH, THEY STILL WANT TO SCAN THE 2D DATA MATRIX BARCODE. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153659 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERINEAL LACERATION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AT 10:00, DURING PERINEAL SUTURING FOR THE PARTURIENT, THE SUTURE BROKE AND WAS REPLACED TO CONTINUE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22074621 ↗
• MalfunctionMay 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AT 15:30, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING SKIN SUTURING. THE INTEGRITY OF THE SUTURE WAS CHECKED IMMEDIATELY: INTACT. THE SUTURE WAS REPLACED AND THE SURGERY CONTINUED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029592 ↗
• MalfunctionApr 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE COSMETIC SUTURING OF THE TROCA INCISION ON THE ABDOMINAL WALL, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AFFECTING THE PROGRESS OF INTRADERMAL SUTURING. AFTER REPLACING THE NEEDLE AND CONNECTING THE REMAINING SUTURE, THE INCISION WAS CONTINUED TO BE SUTURED. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927952 ↗
• MalfunctionApr 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AT AROUND 10:10, THE DOCTOR WAS SUTURING THE PATIENT AND USING A NEEDLE HOLDER TO REMOVE THE SUTURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE SUTURE WAS IMMEDIATELY REPLACED FOR SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860088 ↗
• MalfunctionMar 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO HYDROSALPINX. THE NEXT MORNING DURING A NORMAL PROCEDURE, WHEN USING THE SUTURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED UNEXPECTEDLY. IT WAS PROMPTLY DISCOVERED AND REPLACED WITH NEW ONE TO COMPLETE THE SURGERY. SECONDARY SUTURING, DELAYING THE SURGICAL PROCESS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21623439 ↗

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