Coated VICRYL VCPB839DRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705031056602), received between Nov 6, 2019 and Jul 28, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Material Separation” (10 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50053322 ↗
• MalfunctionJun 4, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FRACTURE OPEN REDUCTION AND INTERNAL FIXATION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE PACKAGING WAS OPENED AND HAIR WAS FOUND EMBEDDED IN THE SLOT OF THE NEEDLE. 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 25398875 ↗
• MalfunctionApr 22, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SURGEON WASHED THE WOUND OF THE PATIENT AND SUTURED THE MUSCLE LAYER, WHICH REQUIRED THE USE OF EIGHT CONVENTIONAL NEEDLES. WHEN THE DOCTOR USED THE SECOND NEEDLE, IT PASSED THROUGH THE MUSCLE LAYER AND THE NEEDLE DISCONNECTED FROM THE SUTURE. THIS SITUATION OCCURRED TWICE IN A ROW, AND THE CIRCULATING NURSE IMMEDIATELY ADDED A NEW PACKAGE OF SUTURE. SIMILAR SITUATIONS DID NOT OCCUR AGAIN AFTERWARDS, WHICH CAUSED SOME DELAY IN TIME. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24952868 ↗
• MalfunctionApr 22, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SURGEON WASHED THE WOUND OF THE PATIENT AND SUTURED THE MUSCLE LAYER, WHICH REQUIRED THE USE OF EIGHT CONVENTIONAL NEEDLES. WHEN THE DOCTOR USED THE SECOND NEEDLE, IT PASSED THROUGH THE MUSCLE LAYER AND THE NEEDLE DISCONNECTED FROM THE SUTURE. THIS SITUATION OCCURRED TWICE IN A ROW, AND THE CIRCULATING NURSE IMMEDIATELY ADDED A NEW PACKAGE OF SUTURE. SIMILAR SITUATIONS DID NOT OCCUR AGAIN AFTERWARDS, WHICH CAUSED SOME DELAY IN TIME. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24952862 ↗
• MalfunctionApr 21, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THE SUTURE PACK WAS FOUND TO BE CONTAMINATED. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE IS NOT RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24939736 ↗
• MalfunctionApr 3, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE OPERATION, WHEN THE DOCTOR WAS SUTURING THE FAT LAYER, THE SUTURE FELL OFF AND THE NEEDLE ENTERED THE SUBCUTANEOUS MUSCLE LAYER. THE ANESTHESIOLOGIST WAS IMMEDIATELY SOUGHT UNDER ULTRASOUND GUIDANCE TO SEARCH FOR IT, BUT IT WAS NOT FOUND. IMMEDIATELY SWITCH TO USING A C-ARM MACHINE FOR FLUOROSCOPY, WITH THE HELP OF THE ORTHOPEDIC DUTY DOCTOR, ACCURATELY LOCATE AND FINALLY FIND THE NEEDLE. AFTER REMOVAL, CONFIRM THE INTEGRITY OF THE NEEDLE WITH THE CIRCULATING NURSE AND THE CHIEF SURGEON AGAIN, OBSERVE THE WOUND HEALING SITUATION, AND COUNT AGAIN BEFORE CONTINUING THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776287 ↗
• MalfunctionMar 31, 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 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 24745296 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THIS CASE IS FROM HEALTH AUTHORITY. THE DOCTOR PERFORMED SURGERY ON THE PATIENT AND USED SUTURE DURING THE OPERATION. ONE OF THE NEEDLE WAS MISSING A NEEDLE TIP AFTER USE. AFTER SEARCHING THE PATIENT'S BODY, THE NEEDLE TIP WAS FOUND AND SAFELY REMOVED. THIS EVENT RESULTED IN A DELAY IN THE PATIENT'S SURGICAL DURATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24569697 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE HAD BEEN FOUND BROKEN IN THE NEWLY DISPENSED SUTURE WHEN PREPARING FOR 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 24240560 ↗
• MalfunctionDec 19, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. UPON OPENING THE STERILIZATION PACKAGE, IT WAS FOUND THAT THERE HAD BEEN A FOREIGN MATTER. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23852091 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AVIATION GENERAL HOSPITAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING SUBCUTANEOUS SUTURING, IT WAS FOUND THAT THE SUTURE WAS VERY BRITTLE. AS SOON AS THE DOCTOR EXERTED FORCE, THE SUTURE BROKE AND WAS NOT SUTURED IN THE PATIENT'S BODY. 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 23605631 ↗
• MalfunctionMar 13, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THE QR CODE COULD NOT BE RECOGNIZED. THERE WAS NO RESPONSE WHEN CUSTOMER SCANNING THE QR CODE IN THE PRIMARY PACKAGE, WHICH COULD NOT BE RECOGNIZED. THE PRODUCT WAS NOT INVOLVED IN ANY SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599318 ↗
• MalfunctionDec 4, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, DURING INTERRUPTING SUTURE, IT WAS FOUND THAT THE SUTURE HAS A FINE SPLIT. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20841713 ↗
• MalfunctionAug 28, 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. DURING THE PROCEDURE, A BLACK GEL LIKE FOREIGN MATTER WAS FOUND ON THE NEEDLE SURFACE IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. 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 20084913 ↗
• MalfunctionAug 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED EASILY. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19995799 ↗
• MalfunctionFeb 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND BARBED SUTURE WAS USED. BEFORE USE ON THE PATIENT, WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE SUTURE WAS ALREADY DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT IT WAS RECEIVED ONE NEEDLE AND SUTURE THAT PERTAINED TO PRODUCT CODE VCPB839D. AFTER INVESTIGATION OF THE SAMPLE, SHORT INSERTION WAS OBSERVED IN THE STRAND. THE VISUAL INSPECTION CONCLUDED THAT THE COMBINATION OF THE NEEDLE/SUTURE WAS DETACHED FROM THE NEEDLE SINCE THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632754 ↗
• MalfunctionFeb 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632506 ↗
• MalfunctionFeb 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632504 ↗
• MalfunctionJan 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18521852 ↗
• MalfunctionNov 3, 2023Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED ON (B)(6) 2023 THAT THE PRODUCT WAS FOUND CONTAMINATED AFTER OPENING THE PACKAGE. THERE IS NOT ANY DAMAGED ON THE OUT PACKAGE. THIS ISSUE WAS FOUND DURING GOODS INSPECTION, NOT INVOLVED IN ANY SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066906 ↗
• MalfunctionJul 6, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT AFTER OPENING THE PACKAGE, IT WAS CONFIRMED THAT THERE WAS A HAIR IN THE STERILE PACKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266410 ↗
• MalfunctionMay 5, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, UPON INITIAL INSPECTION OF THE SAMPLES, THERE IS A PARKED NEEDLE, AN UNDISPENSED SUTURE, AND SIX PARKED NEEDLES/SUTURES COMBINATION, NO EXTERNAL DAMAGES WERE OBSERVED ON THE SIX SAMPLES. THE PRODUCT IS A CONTROL RELEASE, AND EACH PACKET CONTAINS EIGHT STRANDS. AFTER INVESTIGATION OF THE SAMPLE SHORT INSERTION WAS OBSERVED IN ONE STRAND (SLOT 8). THE VISUAL INSPECTION CONCLUDED THAT THE COMBINATION OF THE NEEDLE/SUTURE WERE FOUND DETACHED SINCE THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14288226 ↗
• MalfunctionNov 6, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORTHOPEDIC SURGICAL PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP WAS BROKEN. THE BROKEN NEEDLE TIP WAS FOUND ON THE COVER CLOTH, AND IT WAS RETRIEVED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9288240 ↗

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