Coated VICRYL VCP603HRecalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10705031054394), received between Nov 5, 2019 and Sep 30, 2026 — classified as 5 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Break” (52 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

Recalls naming this device

1. May 10, 2024Class IIOpen, Classified

   Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

   Z-2145-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  It was reported a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. When opening the package, the wire was broken, during the procedure before use.Upon receipt and analysis, a short insertion was noted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946712 ↗
• MalfunctionSep 28, 2026Break

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. It was reported that the needle broken on the suture during the surgery. There is no Adverse Impact on patient/user reported. Device is not available for return. Additional information was requested.

  Patient problems: Insufficient Information

  MAUDE report 50917545 ↗
• MalfunctionSep 1, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548953 ↗
• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308076 ↗
• MalfunctionJun 18, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT ON AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25549572 ↗
• MalfunctionMay 1, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF OF THE SUTURE WHILE SURGEON WAS SUTURING IN THE FASCIA. NO PATIENT CONSEQUENCES. DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057379 ↗
• MalfunctionApr 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING CLOSING FASCIA ON LAPAROSCOPIC SITE, A NEEDLE BROKE. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829498 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PT ROBOTIC PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP THAT DURING A PT ROBOTIC PROCEDURE, THE SUTURE BROKE INTO TWO PIECES. NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24798815 ↗
• MalfunctionMar 25, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2026 AND SUTURE WAS USED. THE NEEDLE BROKE. THE NEEDLE DID FALL INTO THE PATIENT. IT TOOK A LOT OF TIME TO FIND THE NEEDLE IN THE PATIENT. THE INCISION HAD TO BE EXTENDED. THEY USED ULTRASOUND AND X-RAY TO LOCATE IT. THE NEEDLE WAS RETRIEVED DURING THE PROCEDURE. NO ADDITIONAL TISSUE DAMAGE OCCURRED. THERE WERE NO PATIENT ADVERSE EVENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690874 ↗
• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYN ROBOTIC PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING THE GYN ROBOTIC PROCEDURE, THE NEEDLE GOT BROKEN INTO TWO PIECES. DEVICES ARE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628260 ↗
• MalfunctionMar 13, 2026

  DURING CLOSING FASCIA ON LAPAROSCOPIC SITE, A NEEDLE (O VICRYL UR-6) BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589480 ↗
• MalfunctionJan 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. NEEDLE BROKE ON THE SECOND PASS THROUGH TISSUE FOR A HASSON TROCAR PLACEMENT. NEEDLE BROKE A QUARTER LENGTH OF THE NEEDLE DOWN FROM THE SWAGE. NEVER HAPPENED BEFORE. THERE WERE NO SIGNIFICANT DELAYS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093240 ↗
• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 3 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 3 ACTUAL PRODUCTS AND 102 REPRESENTATIVE SAMPLES FOR ANALYSIS. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864533 ↗
• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 3 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 3 ACTUAL PRODUCTS AND 102 REPRESENTATIVE SAMPLES FOR ANALYSIS. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864521 ↗
• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 3 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 3 ACTUAL PRODUCTS AND 102 REPRESENTATIVE SAMPLES FOR ANALYSIS. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864519 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT LAPAROSCOPIC REPAIR OF EXTRAPERITONEAL HERNIA ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SURGERY, THE DOCTOR SUTURED THE OUTER LAYER OF THE PERITONEUM AND FOUND THAT THE NEEDLE TIP WAS MISSING WHEN REMOVING THE NEEDLE. 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 23852325 ↗
• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. AT THE END OF THE PROCEDURE THE SUTURE THE NEEDLE IS BROKEN, SO A NEW ONE IS REQUESTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23788739 ↗
• MalfunctionNov 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR PER ACCOUNT THAT THE CST REPORTING ITEM DEFECTIVE. TIP OF THE SUTURE NEEDLE BROKE OFF IN THE PATIENT. PRODUCT IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23465280 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MINIMALLY INVASIVE LUMBAR HERNIA SURGERY ON (B)(6) 2025 AND SUTURE WAS USED TO CLOSE THE SURGICAL WOUND FOR FASCIAL CLOSURE. ON (B)(6) 2025, AFTER BEING DISCHARGED, THE PATIENT TOLD THE DOCTOR THAT THE WOUND WAS OOZING AND DEHISCING. THE DOCTOR IMMEDIATELY PRESCRIBED MEDICATION TO PREVENT INFECTION AND BEGAN WOUND MANAGEMENT. REVIEWING THE INCIDENT WITH THE DOCTOR, HE STATED THAT THE PATIENT'S CASE WAS NOT RELATED TO A SURGICAL SITE INFECTION, AS THERE WAS RE-EPITHELIALIZATION AT THE WOUND EDGES AND THERE WEREN´T ANY OTHER SSI ALARM DATA. RATHER, IT WAS AN ALLERGIC REACTION TO THE SUTURE. ONCE THE STITCH OF SUTURE WAS REMOVED, THE INFLAMMATORY REACTION SUBSIDED, AND A SECONDARY WOUND CLOSURE WAS POSSIBLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Insufficient Information; Purulent Discharge; Wound Dehiscence

  MAUDE report 23361370 ↗
• InjurySep 9, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY ON (B)(6) 2025 AND SUTURE WAS USED FOR UMBILICAL ORIFICE CLOSURE. SURGICAL RESUMPTION (B)(6) 2025 FOR EVISCERATION; DURING RESUMPTION FINDING THAT THE THREADS AND APONEUROSIS ARE INTACT, BUT THE KNOTS HAVE LOOSENED (SLIPPING), DUE TO THE COATED CHARACTER OF THE THREAD. PATIENT HAD EVISCERATION WITH EMERGENCY RECOVERY. THE OLD REGULAR SUTURE WAS USED DURING THE RE-OP. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 23003441 ↗
• MalfunctionAug 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING SURGERY, THE NEEDLE WAS BROKEN AT THE SWAGE PART WHEN CLOSING THE TROCAR WOUND DURING USE. ONE NEEDLE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22773983 ↗
• MalfunctionJun 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE DETACHED EASILY FROM THE NEEDLE. THIS HAPPENED TWICE THIS WEEK WITH THIS LOT NUMBER, AND THEY COULD HAVE LOST THE NEEDLE IN THE PATIENT'S ABDOMEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203183 ↗
• MalfunctionJun 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE DETACHED EASILY FROM THE NEEDLE. THIS HAPPENED TWICE THIS WEEK WITH THIS LOT NUMBER, AND THEY COULD HAVE LOST THE NEEDLE IN THE PATIENT'S ABDOMEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203181 ↗
• MalfunctionMay 29, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, INCORRECT QUANTITY-MISSING PACKAGES. IT WAS REPORTED THAT THERE WAS ONE PACKAGE OF PRODUCT LESS THAN EXPECTED IN THE BOX WHEN JUST OPENED . THERE SHOULD BE THIRTY-SIX PACKAGE OF PRODUCTS IN THE BOX, BUT ACTUALLY THERE WERE ONLY THIRTY-FIVE PACKAGE OF PRODUCTS. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. UPON THE VISUAL INSPECTION OF THE RECEIVED BOX, IT WAS FOUND TO CONTAIN THIRTY-FIVE FOIL PACKETS INSTEAD OF THIRTY-SIX. AS PER PRODUCT REQUIREMENTS, THE BOX SHOULD CONTAIN THIRTY-SIX PACKAGES. THE TAB DISPENSER WAS REMOVED FROM THE BOX, AND ONE SIDE OF THE BOX WAS CRUSHED. IN ADDITION, IT WAS NOTED THAT THE FOIL PACKETS WERE RELABELED. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22108299 ↗
• MalfunctionApr 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARTMAN REVERSAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE BROKE OFF OF THE SUTURE. CASE WAS COMPLETED WITH A LIKE DEVICE. NEEDLE WAS FOUND AND REMOVED FROM PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858071 ↗

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-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