Coated VICRYL VCP739DRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10705031055179), received between Dec 6, 2017 and Sep 25, 2026 — classified as 4 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  It was reported that a patient underwent laparoscopic nephrectomy for renal lesions surgery on (b)(6)2026 and suture was used. When the surgeon performs tissue suturing, it is found that the suture used is significantly more brittle and prone to breakage. It breaks multiple times during normal knotting and pulling processes, seriously affecting the suturing efficiency and increasing surgical risks. The surgeon immediately stopped using the problematic suture and replaced it with another batch of suture of the same specification. After confirming that the suture's flexibility and strength were normal, the surgery continued. The patient's vital signs remained stable during the operation, and there were no postoperative bleeding or other complications due to suture issues. No further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902473 ↗
• MalfunctionSep 25, 2026Break

  It was reported that a patient underwent laparoscopic nephrectomy for renal lesions surgery on (b)(6) 2026 and suture was used. When the surgeon performs tissue suturing, it is found that the suture used is significantly more brittle and prone to breakage. It breaks multiple times during normal knotting and pulling processes, seriously affecting the suturing efficiency and increasing surgical risks. The surgeon immediately stopped using the problematic suture and replaced it with another batch of suture of the same specification. After confirming that the suture's flexibility and strength were normal, the surgery continued. The patient's vital signs remained stable during the operation, and there were no postoperative bleeding or other complications due to suture issues. No further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902471 ↗
• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. 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 24927652 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. 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 24506647 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. 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 24506595 ↗
• MalfunctionAug 15, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT IN (B)(6) 2025 THE 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. CHANGED ANOTHER ONE, THE SAME PROBLEM HAPPENED. THE LOT OF THE IP IS UNAVAILABLE. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815918 ↗
• MalfunctionAug 15, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT IN (B)(6) 2025 THE 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. CHANGED ANOTHER ONE, THE SAME PROBLEM HAPPENED. THE LOT OF THE IP IS UNAVAILABLE. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815904 ↗
• MalfunctionJun 4, 2025Material Discolored; Material Discolored

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE DOCTOR OPENED THE PACKAGE AND FOUND THAT THE COLOR OF THE SUTURE HAD CHANGED, WITH TWO COLORS: DEEP PURPLE AND LIGHT PURPLE. CHANGED TO ANOTHER ONE TO COMPLETE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140759 ↗
• MalfunctionMay 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. WHILE PREPARING FOR SUTURING, THE SUTURE BROKE WITH A GENTLE PULL, AND A NEW SUTURE WAS IMMEDIATELY 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 21977851 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN EXPLORATION, TOTAL SPLENECTOMY, AND PANCREATIC TAIL REPAIR PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO MULTIPLE INJURIES TO THE LEFT CHEST AND ABDOMEN CAUSED BY A FALL, WITH PAIN LASTING FOR MORE THAN 4 HOURS. THE SURGERY WAS PERFORMED ON THE SAME DAY AND WENT SMOOTHLY. A DOUBLE SET OF DRAINAGE TUBES WERE PLACED IN THE SPLENIC FOSSA. FINALLY, THE DOCTOR USED SUTURES TO SUTURE THE SUBCUTANEOUS TISSUE OF THE UPPER ABDOMINAL SEGMENT, AND A 7-8MM NEEDLE BROKE. THEREFORE, A C-ARM MACHINE, ABDOMINAL PLAIN FILM EXAMINATION, AND FULL ABDOMINAL CT EXAMINATION WERE PERFORMED, AND NO METAL FOREIGN BODIES WERE FOUND. IT WAS DETERMINED THAT THE BROKEN NEEDLE WAS NOT LEFT IN THE PATIENT'S BODY, AND THE PATIENT RETURNED TO THE WARD SAFELY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752134 ↗
• MalfunctionMar 14, 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, DURING THE SURGERY, AFTER UNPACKING, IT WAS FOUND THAT ONE NEEDLE IN THE SUTURE ONLY HAD A NEEDLE AND NO SUTURE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY. DURING USE, ONE NEEDLE EXPERIENCED THE PROBLEM OF PULLING OFF SUTURE NEEDLE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. UPON VISUAL INSPECTION OF THE RETURNED SAMPLE, THE NEEDLE SUTURE COMBINATIONS WERE REMOVED FROM THE TRAY, AND THE SUTURE FROM THE NEEDLE IN SLOT #1 WAS FOUND WITHIN THE TRAY. THE SUTURE WAS EXAMINED, AND A SHORT INSERTION WAS OBSERVED DURING THE EVALUATION. BASED ON THE INFORMATION CURRENTLY AVAILABLE, SHORT INSERTION ISSUE WAS IDENTIFIED AS WRONG NUMBER OF STRANDS DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. 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 21607798 ↗
• MalfunctionMar 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, DURING THE SURGERY, AFTER UNPACKING, IT WAS FOUND THAT ONE NEEDLE IN THE SUTURE ONLY HAD A NEEDLE AND NO SUTURE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY. DURING USE, ONE NEEDLE EXPERIENCED THE PROBLEM OF PULLING OFF SUTURE NEEDLE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. UPON VISUAL INSPECTION OF THE NEEDLES, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE BARREL HOLE OF THE NEEDLES WAS EXAMINED UNDER MAGNIFICATION, AND NO SUTURE REMNANTS WERE NOTED. THE DETACHED SUTURES WERE INSPECTED, AND THE INSERTION MARK COULD NOT BE OBSERVED. DURING THE VISUAL INSPECTION OF THE NEEDLE-SUTURE COMBINATION, NO ANOMALIES OR ISSUES RELATED TO PULL-OFF WERE OBSERVED. THIS PRODUCT CODE CONTAINS AN ABSORBABLE SUTURE. 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 21607792 ↗
• MalfunctionNov 12, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  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 THE PRIMARY PACKAGE OF THE SUTURE WAS FOUND DAMAGED PRIOR TO USE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. PLEASE REFER TO THE ATTACHED PHOTOS OF THE DEFECT PRODUCT. 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 20666218 ↗
• MalfunctionJun 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19622978 ↗
• MalfunctionJan 11, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND A SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18495126 ↗
• MalfunctionDec 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED WHEN THE SURGEON ATTEMPTED TO SEW THE PATIENT'S BLEEDING SITE. 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 18352788 ↗
• MalfunctionNov 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE 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 18187177 ↗
• MalfunctionDec 7, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING PREPARATION FOR THE PROCEDURE, THERE HAD BEEN HAIR FOREIGN MATTER IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15935533 ↗
• MalfunctionJun 1, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN LUNG RESECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. IT WAS REPORTED THAT DURING RADICAL RESECTION OF LUNG CANCER SURGERY, WHEN JUST OPEN THE PACKAGE, THE DEVICE IN SLOT 1 WAS FOUND NO SUTURE BUT ONLY NEEDLE, AND THE THERE'S NO NEEDLE TIP OF THE DEVICE IN SLOT 2. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14570670 ↗
• MalfunctionMay 24, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT DURING THE SURGERY, THE NEEDLE HOLDER WAS USED TO CLAMP THE NEEDLE, AND THE NEEDLE BROKE, AND THE SUTURE NEEDLE WAS REPLACED IN TIME. CHANGED 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 14487614 ↗
• MalfunctionMay 16, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FOR DEBRIDEMENT, EXPLORATION AND REPAIR OF FOOT ON 2/14/2022 AND SUTURE WAS USED. THE PATIENT WAS TREATED WITH "RIGHT FOOT SKIN CRACK BLEEDING CAUSED BY FALLING FOR 1 HOUR. AFTER THE FASCIA WAS SUTURED DURING THE OPERATION, WHEN THE SKIN NEEDS TO BE SUTURED, THE SUTURE WAS BROKEN. CHANGED 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 14409166 ↗
• MalfunctionFeb 1, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2021 AND SUTURE WAS USED. WHEN THE DOCTOR OPENED THE SUTURE PACKAGE AND WAS ABOUT TO SEW THE SKIN IN THE SURGERY, THE SUTURE WAS BROKEN FROM THE MIDDLE BY GENTLY PULLING THE SUTURE. IT WAS IMMEDIATELY REPLACED WITH A NEW SUTURE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13407639 ↗
• MalfunctionJan 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT CLOSED REDUCTION AND INTERNAL FIXATION OF AN INTERTROCHANTERIC FRACTURE ON OCTOBER 15, 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. CHANGED 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 13253313 ↗
• MalfunctionOct 5, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CHEST PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING INTERRUPTED SUTURING ON THE FASCIA. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576368 ↗
• MalfunctionDec 18, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CLOSED REDUCTION AND INTERNAL FIXATION OF LEFT INTERTROCHANTERIC FRACTURE PROCEDURE ON (B)(6) 2020, AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11041085 ↗

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