Coated VICRYL VCP772DRecalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 10705031055476), received between Jan 16, 2018 and Sep 3, 2026 — classified as 8 injuries, 96 malfunctions.

The most frequently reported specific device problem is “Break” (56 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Break; Material Separation

  Patient problems: Insufficient Information

  MAUDE report 50592013 ↗
• MalfunctionJun 8, 2026Product Quality Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS FOUND TO HAVE AN EXTRA KNOT AND THE THICKNESS OF THE SUTURE WAS UNEVEN, WHICH AFFECTED THE SUTURE QUALITY. REPLACED WITH NEW SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25435540 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN LAPAROSCOPIC RADICAL RESECTION OF RIGHT COLON CANCER PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT DURING SURGERY, THE NEEDLE TIP BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE SURGERY. ENCLOSED PLEASE FIND DEFECT PHOTO. THE BROKEN NEEDLE WAS RETRIEVED SHORTLY. THE PROCEDURE WAS COMPLETED AND NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056339 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SUDDENLY BROKE WHILE SUTURING THE WOUND DURING SURGERY AND WAS IMMEDIATELY REPLACED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24808718 ↗
• MalfunctionMar 24, 2026Break; Product Quality Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BRITTLE, KNOTTED, AND BROKEN, MAKING IT UNUSABLE. AFTER REPLACING THE SUTURE, IT CAN MEET CLINICAL SUTURE NEEDS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676459 ↗
• MalfunctionFeb 24, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXPLORATION AND REMOVAL OF COMMON BILE DUCT STONES PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AT THE END OF THE SURGERY, THE DOCTOR FOUND THAT THE NEEDLE ON THE SUTURE IN THE ABDOMINAL CAVITY HAD DISAPPEARED FOR UNKNOWN REASONS, CAUSING THE SURGERY TO BE INTERRUPTED. EVERYONE HAD TO SEARCH FOR THE NEEDLE. DURING THE OPERATION, IT WAS FOUND THAT THE NEEDLE HAD DISAPPEARED, AND BOTH ON STAGE AND OFF STAGE SEARCHES WERE UNSUCCESSFUL. THEN, THE ORTHOPEDIC DEPARTMENT USED GB ABDOMINAL AND PELVIC COMPREHENSIVE FLUOROSCOPY MULTIPLE TIMES, AND FINALLY FOUND IT AT THE LOWER EDGE OF THE LIVER. THE DOCTOR USED LAPAROSCOPY AND INSTRUMENTS TO REMOVE THE NEEDLE AND CLOSED THE ABDOMEN. THE ABDOMINAL CLOSURE TIME WAS DELAYED BY 80 MINUTES DURING THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24428309 ↗
• MalfunctionJan 28, 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 24201133 ↗
• MalfunctionDec 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 PROCESS OF SUTURING THE SURGICAL INCISION, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. IMMEDIATELY REPLACED THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917058 ↗
• MalfunctionNov 17, 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, IT WAS REPORTED BY A SALES REP THAT THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. POSSIBLE LOT NUMBER IS 109A57. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23571269 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXPLORATION AND REPAIR OF NERVES, BLOOD VESSELS, AND TENDONS IN THE OPEN INJURY OF THE RIGHT THIGH, VASCULAR ANASTOMOSIS, AND INTRAMUSCULAR SUTURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SURGERY DUE TO A SHARP OBJECT STABBING THE THIGH AND CAUSING TRAUMA. DURING THE SURGERY, THE MUSCLE WAS SUTURED WITH SUTURE. HOWEVER, HALFWAY THROUGH THE SUTURE, THE NEEDLE SUDDENLY BROKE FROM THE BACK ONE-THIRD OF THE NEEDLE TAIL. THE DOCTOR ON STAGE URGENTLY HANDLED THE SITUATION AND REMOVED THE BROKEN NEEDLE FROM THE BODY. AFTER EXAMINATION, THE BROKEN NEEDLE WAS FOUND TO BE INTACT AND THERE WAS NO RESIDUE IN THE BODY. THE SUTURE WAS THEN REMOVED FROM THE BODY AND ANOTHER SUTURE WAS USED FOR THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23479132 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CHIEF SURGEON USED SUTURE TO SUTURE THE SUBCUTANEOUS TISSUE DURING THE SURGERY. DURING THE OPERATION, THE NEEDLE SUDDENLY BROKE DURING NORMAL INSERTION, LEAVING SOME OF THE NEEDLE BODY IN THE PATIENT'S BODY. AFTER DISCOVERING A BROKEN NEEDLE, THE DOCTOR IMMEDIATELY SUSPENDED THE SUTURING OPERATION, CAREFULLY EXPLORED WITH INSTRUMENTS, AND SUCCESSFULLY REMOVED ALL BROKEN NEEDLE FRAGMENTS TO CONFIRM THEIR INTEGRITY AND AVOID FOREIGN BODY RESIDUE; TAKE PHOTOS OF THE BROKEN NEEDLE BODY FOR PRESERVATION AND SEAL THE RELEVANT INSTRUMENTS; REPORT TO THE HEAD NURSE OF THE DEPARTMENT IN A TIMELY MANNER. THE PATIENT'S POSTOPERATIVE VITAL SIGNS ARE STABLE AND HAVE BEEN INCLUDED IN THE POSTOPERATIVE KEY OBSERVATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 23458392 ↗
• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THERE WAS SOMETHING LIKE A NEEDLE ATTACHED WHEN STERILIZATION PROCESS OF NEEDLE-HOLDER. IT WAS NOT A CONTROL RELEASE NEEDLE. THE LOT NUMBER IS UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS EVENT WAS REPORTED BY A DOCTOR THAT NO PIECES WERE LEFT INSIDE THE PATIENT. THE PART WHERE THE NEEDLE BROKE IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. THE EVALUATION OF (B)(4) REVEALED THE FRACTURE WAS COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE FRACTURE MODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368113 ↗
• MalfunctionOct 20, 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, IT WAS REPORTED THAT THERE WAS ONE PACKAGE OF PRODUCT LESS THAN EXPECTED IN THE BOX WHEN JUST OPENED. THERE SHOULD BE TWELVE PACKAGES OF PRODUCTS IN THE BOX, BUT ACTUALLY THERE WERE ONLY ELEVEN PACKAGES OF PRODUCTS. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. 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 23341362 ↗
• MalfunctionAug 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEUROSURGERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN NEUROSURGERY, THE SUTURE WAS BROKEN WHEN THE NEEDLE HOLDER WAS HELD ABOUT 1/3 OF THE WAY FROM THE CAUDAL SIDE DURING USE. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798023 ↗
• MalfunctionAug 7, 2025Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THE SUTURE WAS NOT SMOOTH AND EASY TO BREAK WHEN SUTURING THE WOUND. WHICH AFFECTED THE SUTURE. REPLACED THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22740316 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE DOCTOR FINISHED SUTURING THE SURGERY AND ATTACHED THE NEEDLE TO THE NEEDLE TRAY, ONE-THIRD OF THE NEEDLE BROKE AND THE REMAINING NEEDLE FLEW OUT OF THE SURGICAL AREA. THE NURSE FOUND IT 2 HOURS LATER, WHICH CAUSED AN EXTENSION OF THE SURGERY TIME AND POSED A SURGICAL RISK. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22515733 ↗
• MalfunctionJul 9, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE PACKAGE WAS BENT WHEN THE BOX WAS OPENED. IT MAY NOT BE A PROBLEM BUT IF THERE IS A HOLE IN IT AND IT COULD BE DANGEROUS, SO THE PRODUCT WAS ACCEPTED AS A DEFECTIVE. THIS EVENT WAS FOUND BEFORE USE. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22457672 ↗
• MalfunctionJul 9, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE PACKAGE WAS BENT WHEN THE BOX WAS OPENED. IT MAY NOT BE A PROBLEM BUT IF THERE IS A HOLE IN IT AND IT COULD BE DANGEROUS, SO THE PRODUCT WAS ACCEPTED AS A DEFECTIVE. THIS EVENT WAS FOUND BEFORE USE. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22457669 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT NEEDED TO SUTURE THE WOUND DUE TO EXTERNAL TRAUMA AND FOUND THAT THE SUTURE HAD QUALITY ISSUES AND WAS PRONE TO BREAKAGE. REPLACED WITH NEW SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899714 ↗
• MalfunctionJan 15, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, THE QR CODE COULD NOT BE RECOGNIZED. THERE WAS NO RESPONSE WHEN SCANNING THE QR CODE IN THE PRIMARY PACKAGE, WHICH COULD NOT BE RECOGNIZED. THE PRODUCT WAS NOT INVOLVED IN ANY SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159023 ↗
• MalfunctionJan 15, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, THE QR CODE COULD NOT BE RECOGNIZED. THERE WAS NO RESPONSE WHEN SCANNING THE QR CODE IN THE PRIMARY PACKAGE, WHICH COULD NOT BE RECOGNIZED. THE PRODUCT WAS NOT INVOLVED IN ANY SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159021 ↗
• MalfunctionJan 15, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, THE QR CODE COULD NOT BE RECOGNIZED. THERE WAS NO RESPONSE WHEN SCANNING THE QR CODE IN THE PRIMARY PACKAGE, WHICH COULD NOT BE RECOGNIZED. THE PRODUCT WAS NOT INVOLVED IN ANY SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159020 ↗
• MalfunctionJan 15, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, THE QR CODE COULD NOT BE RECOGNIZED. THERE WAS NO RESPONSE WHEN SCANNING THE QR CODE IN THE PRIMARY PACKAGE, WHICH COULD NOT BE RECOGNIZED. THE PRODUCT WAS NOT INVOLVED IN ANY SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159019 ↗
• MalfunctionJan 15, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, THE QR CODE COULD NOT BE RECOGNIZED. THERE WAS NO RESPONSE WHEN SCANNING THE QR CODE IN THE PRIMARY PACKAGE, WHICH COULD NOT BE RECOGNIZED. THE PRODUCT WAS NOT INVOLVED IN ANY SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159017 ↗
• MalfunctionJan 15, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON(B)(6)2024 AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, THE QR CODE COULD NOT BE RECOGNIZED. THERE WAS NO RESPONSE WHEN SCANNING THE QR CODE IN THE PRIMARY PACKAGE, WHICH COULD NOT BE RECOGNIZED. THE PRODUCT WAS NOT INVOLVED IN ANY SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159016 ↗

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