Coated VICRYL VCP371H (UDI 10705031052857)Recalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 10705031052857), received between Aug 14, 2019 and May 21, 2026 — classified as 4 injuries, 113 malfunctions.

The most frequently reported specific device problem is “Material Separation” (66 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 117 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE 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. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250410 ↗
• MalfunctionDec 31, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THERE ARE SOME BLACK SPOT COATED ON THE NEEDLE. THE NEEDLE SEEMS LIKE RUSTED. NOT FOREIGN MATERIAL, IT IS THE NEEDLE ITSELF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935842 ↗
• InjuryDec 9, 2025Failure to Degrade; Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT VAGINAL DELIVERY ON (B)(6) 2025 AND SUTURE WAS USED ON A PERINEUM FIRST DEGREE LACERATION. THE SUTURING WAS SUCCESSFUL. THE PATIENT WAS DISCHARGED ONE DAY LATER. THREE DAYS AFTER THE SURGERY, THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT DUE TO SWELLING AND PAIN IN THE PERINEAL WOUND. UPON EXAMINATION, A 1 X 2CM RUPTURE WAS FOUND AT THE SITE OF THE PERINEAL FISSURE, WITH PURULENT DISCHARGE, INFLAMMATION AND UNABSORBED SUTURE. INCISION SUTURE WAS REMOVED, MEDICAL WOUND CARE MEMBRANE WAS USED TO CARE FOR THE WOUND, AND CEFACLOR SUSTAINED-RELEASE TABLETS WERE USED TO RESIST INFECTION. AFTER 55 DAYS OF OPERATION, THE PERINEAL WOUND HEALED WELL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Inflammation; Pain; Purulent Discharge; Swelling/ Edema; Wound Dehiscence

  MAUDE report 23761223 ↗
• InjuryDec 9, 2025Failure to Degrade; Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2025 AND SUTURE WAS USED ON THE ABDOMINAL INCISION SUCCESSFULLY. THE PATIENT WAS DISCHARGED 6 DAYS LATER. AT THE TIME OF DISCHARGE, THERE WAS NO REDNESS, SWELLING, OR EXUDATION IN THE ABDOMINAL INCISION. 26 DAYS AFTER THE SURGERY, THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT DUE TO EXCESSIVE ABDOMINAL EXUDATE. UPON EXAMINATION, IT WAS FOUND THAT THE SUTURE OF THE ABDOMINAL INCISION WAS NOT ABSORBED, THE INCISION WAS SWOLLEN AND PAINFUL WITH INFLAMMATION, AND THERE WERE MANY PALE YELLOW SECRETIONS FLOWING OUT. ADMINISTERED METRONIDAZOLE INJECTION, SODIUM CHLORIDE INJECTION, AND HYDROGEN PEROXIDE SOLUTION FOR WOUND DEBRIDEMENT. AND TRADITIONAL CHINESE MEDICINE WAS USED TO PROMOTE WOUND HEALING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Inflammation; Pain; Swelling/ Edema

  MAUDE report 23761219 ↗
• MalfunctionSep 26, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, ON THE LABEL OF THE BOX IS CODE VCP371H, INTERNALLY CONTAINS SUTURES WITH CODE VCP353. THE CUSTOMER REQUESTS THE CHANGE OF THE MATERIAL. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23158846 ↗
• MalfunctionAug 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE, FROM A DIFFERENT PRODUCT CODE AND LOT NUMBER, TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. 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 22776978 ↗
• MalfunctionAug 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE, FROM A DIFFERENT PRODUCT CODE AND LOT NUMBER, TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. 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 22776780 ↗
• MalfunctionJul 29, 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, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THERE WILL RETURN 1 ACTUAL PRODUCTS AND 21 REPRESENTATIVE SAMPLES FOR ANALYSIS. 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 22644630 ↗
• MalfunctionJul 28, 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 THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. 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 22637210 ↗
• MalfunctionJul 28, 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 THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. 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 22637069 ↗
• MalfunctionJul 28, 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 THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. 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 22637050 ↗
• MalfunctionJul 28, 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 THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. 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 22636821 ↗
• MalfunctionJul 28, 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 THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. 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 22636770 ↗
• MalfunctionJul 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. REPORTED AS SURGEON HAD TRIED TO USE 4 FOILS OF VCP371H AND EACH TIME THE NEEDLE POPPED OFF. KEPT THE REST OF THE BOX TO RETURN TO TEST. COMMENTED THAT 2 OF THE SUTURES FELL OFF WHEN LOADING INTO NEEDLE HOLDER BEFORE PASSING INTO TISSUE. HE THEN GOT HIS REGISTRAR TO CHECK 2 MORE AND BOTH AGAIN HAD SUTURE DETACH FROM NEEDLE WITH VERY LITTLE FORCE; CUSTOMER WAS NOT ABLE TO DETERMINE WHICH LOT RELATED TO COMPLAINT SO PLEASE TEST BOTH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436240 ↗
• MalfunctionJul 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. REPORTED AS SURGEON HAD TRIED TO USE 4 FOILS OF VCP371H AND EACH TIME THE NEEDLE POPPED OFF. KEPT THE REST OF THE BOX TO RETURN TO TEST. COMMENTED THAT 2 OF THE SUTURES FELL OFF WHEN LOADING INTO NEEDLE HOLDER BEFORE PASSING INTO TISSUE. HE THEN GOT HIS REGISTRAR TO CHECK 2 MORE AND BOTH AGAIN HAD SUTURE DETACH FROM NEEDLE WITH VERY LITTLE FORCE; CUSTOMER WAS NOT ABLE TO DETERMINE WHICH LOT RELATED TO COMPLAINT SO PLEASE TEST BOTH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436236 ↗
• MalfunctionJun 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT NEEDLE WAS FOUND OXIDATION IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. 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 22287074 ↗
• MalfunctionJun 17, 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, WHEN MEDICAL PERSONNEL USED SUTURE FOR SURGICAL SUTURING, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND WAS STOPPED FROM USE. NEW SUTURE WAS REPLACED AND THE BROKEN PART WAS SEARCHED FOR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22233045 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, INTRA-OP WHILE PERFORMING A CAESAREAN NEEDLE TIP BROKEN OFF, XRAY NEEDED TO LOCATE WAS FOUND ON DRAPE. DELAY IN SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005134 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE REP THE NEEDLE TIP BROKE OFF OF THIS SUTURE WHILE SEWING IN A HASSAN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. SURGICAL DELAY UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919737 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING PROCEDURE WHEN USING SUTURE, THE TIP OF THE NEEDLE WAS FRACTURED AND IT WAS NOT KNOWN IF IT REMAINED INSIDE THE PATIENT. X-RAY EQUIPMENT WAS USED TO LOOK FOR IT BUT WAS NOT FOUND. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919676 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING PROCEDURE WHEN USING SUTURE, THE TIP OF THE NEEDLE WAS FRACTURED AND IT WAS NOT KNOWN IF IT REMAINED INSIDE THE PATIENT. X-RAY EQUIPMENT WAS USED TO LOOK FOR IT BUT WAS NOT FOUND. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919671 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IN C/SECTION CASE WE HAD A SUTURE NEEDLE TIP SNAPPED INTRAOPERATIVELY. THE SURGICAL TEAM NOTED IT AT TIME OF SURGERY AND WERE ABLE TO RETRIEVE THE NEEDLE TIP. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919244 ↗
• MalfunctionApr 28, 2025Material Separation; Material 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 21917768 ↗
• MalfunctionApr 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AT AROUND 3:00 PM, THE PATIENT UNDERWENT SURGERY AND NEEDED TO SUTURE THE WOUND WITH SUTURE. DURING THE SUTURE PROCESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND COULD NOT BE USED. THE SURGERY CONTINUED AFTER REPLACING THE SUTURE WITH NEW ONE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21764535 ↗
• MalfunctionMar 21, 2025Material Separation; Material 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 WHEN SEWING DURING THE SURGERY. THE NEEDLE DID NOT FALL INTO THE PATIENT. 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 21665276 ↗

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