Coated VICRYL VCP784DRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705031055551), received between Apr 22, 2020 and Feb 23, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. 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 24420956 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. 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 24420914 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OB-GYN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN OB-GYN SURGERY, THE NEEDLE TIP HAD BEEN BROKEN. NO PIECES WERE LEFT INSIDE THE PATIENT. 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. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO NEEDLE PIECE FELL INTO THE SURGICAL FIELD WHEN THE NEEDLE WAS BROKEN. 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 23598037 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANNICULECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING PANNICULECTOMY PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556708 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TITLE: HAND-SEWN GASTROJEJUNAL ANASTOMOSIS REDUCES DELAYED GASTRIC EMPTYING AFTER PANCREATICODUODENECTOMY: A SINGLE-CENTER RETROSPECTIVE CLINICAL STUDY OF 1,077 CONSECUTIVE PATIENTS. THE AIM OF THIS STUDY WAS TO IDENTIFY FACTORS THAT INFLUENCE DELAYED GASTRIC EMPTYING AFTER PANCREATICODUODENECTOMY AND ASSESS THE IMPACT OF DIFFERENT ANASTOMOTIC METHODS ON DELAYED GASTRIC EMPTYING. THE STUDY INCLUDED 1,077 PATIENTS WHO HAD UNDERGONE EITHER HAND-SEWN ANASTOMOSIS (N = 734) OR STAPLED ANASTOMOSIS (N = 343) DURING PANCREATICODUODENECTOMY BETWEEN DECEMBER 2016 AND NOVEMBER 2021 AT OUR DEPARTMENT. TWO METHODS, HA AND SA, WERE USED BY THE PANCREATIC SURGERY CENTER OF CHANGHAI HOSPITAL OF THE CHINESE PLA DURING GASTROJEJUNAL / DUODENOJEJUNAL ANASTOMOSIS. A 75-MM LINEAR CUTTER (TLC75) WAS USED TO TRANSECT THE DISTAL STOMACH (APPROXIMATELY 60% OF THE STOMACH REMAINED)/PROXIMAL DUODENUM. THE HA TECHNIQUE INVOLVED THE FOLLOWING STEPS: SECOND, FULL-LAYER ANASTOMOSIS WAS PERFORMED USING A CONTINUOUS LOCK STITCH, IN WHICH AN ABSORBABLE 3-0 SUTURE (VCP7840) WAS USED (FIGURE 1, B). FINALLY, THE SEROMUSCULAR LAYER WAS REINFORCED WITH 3-0 SUTURES (VCP784D) ALONG THE ANASTOMOSIS (FIGURE 1, C). IN SA, TH

  Patient problems: Fistula; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Unspecified Infection

  MAUDE report 21551696 ↗
• MalfunctionJan 16, 2025Component Missing; Device Contaminated During Manufacture or Shipping; Component Missing; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THERE WAS ONE SUTURE LESS THAN EXPECTED IN THE NEWLY DISPENSED SUTURE WHEN PREPARING FOR SURGERY. THERE SHOULD BE EIGHT SUTURES IN THE PACKAGE, BUT ACTUALLY THERE WERE ONLY SEVEN SUTURES. BESIDES, FOREIGN MATTER WAS FOUND ON THE NEEDLE SURFACE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173031 ↗
• MalfunctionNov 19, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE DOCTOR USED SUTURE TO SUTURE THE INCISION FOR THE PATIENT DURING THE SURGERY. DURING THE SUTURE PROCESS, THE NEEDLE TIP BROKE, POSING A RISK OF INFECTION TO THE PATIENT DUE TO THE NEEDLE TIP REMAINING IN THE BODY. 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 20730216 ↗
• MalfunctionNov 4, 2024Break; Break

  IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT NEEDLE BREAKAGE WAS OBSERVED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE HAD BEEN FOUND BROKEN BEFORE USING ON PATIENT DURING SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE SURGEON REFUSED TO USE FOUR UNUSED SUTURES IN THE SAME POUCH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599945 ↗
• MalfunctionOct 24, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT IT WAS FOUND THAT THERE HAD BEEN FOREIGN MATTER (AS THE PHOTO SHOWS) IMMEDIATELY ONCE OPENED THE PACKAGE WHEN PREPARING FOR SURGERY . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523558 ↗
• MalfunctionMar 1, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THE BROKEN NEEDLE WAS RETRIEVED SHORTLY. THE PROCEDURE WAS COMPLETED AND NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18820383 ↗
• MalfunctionMar 1, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THE BROKEN NEEDLE WAS RETRIEVED SHORTLY. THE PROCEDURE WAS COMPLETED AND NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18820380 ↗
• MalfunctionFeb 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC REPAIR OF DUODENAL ULCER PERFORATION UNDER GENERAL ANESTHESIA PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 15:20, THE DOCTOR SUTURED THE PERFORATION SITE WITH SUTURE DURING SURGERY. WHEN PULLING THE NEEDLE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE ABDOMINAL CAVITY, AND THEN THE NEEDLE WAS REMOVED UNDER DIRECT ENDOSCOPY. THIS EVENT CAUSED AN EXTENSION OF THE SURGICAL TIME AND INCREASED THE RISK OF UNCLEAR ITEM COUNTING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18679686 ↗
• MalfunctionDec 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2023 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED BEFORE USING ON PATIENT DURING SURGERY. 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 18415676 ↗
• MalfunctionJul 10, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC FLAP PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17290412 ↗
• MalfunctionMay 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC RIGHT HEMICOLECTOMY PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING THE SURGERY, THE DOCTOR USED SUTURE TO SEW THE PATIENT'S PURSE. AT THE END OF THE SUTURE, THE DOCTOR TOOK OUT THE BODY AND FOUND THAT THE NEEDLE WAS HALF BROKEN. THE DOCTOR SEARCHED FOR IT IN A TIMELY MANNER, AND FINALLY FOUND IT IN THE PUNCTURE CARD, WHICH WAS PIECED TOGETHER COMPLETELY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035174 ↗
• MalfunctionJan 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SIGMOIDECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHILE CLOSING THE FACIA WHEN THE SURGEON SET THE TAB, THE TAB BROKE IN HALF AND PULLED THROUGH THE FACIA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13238624 ↗
• MalfunctionJan 4, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL GASTROINTESTINAL SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING KNOTTING AT THE GASTROINTESTINAL ANASTOMOSIS. CHANGED 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 11107880 ↗
• MalfunctionApr 22, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AFTER SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9985659 ↗
• MalfunctionApr 22, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AFTER SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9985651 ↗

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