Coated VICRYL VCP740DRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031055193), received between Jun 27, 2019 and Jan 12, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SALES REP REPORTED THERE WERE MULTIPLE PULL OF SUTURE NEEDLE CASE OCCURRED BEFORE. THE EVENT TIME AND PRODUCT QUANTITY CAN'T BE CONFIRMED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24046175 ↗
• MalfunctionDec 30, 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, SUTURE WAS USED FOR SURGICAL SUTURING OF THE PATIENT. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND THE SURGERY CONTINUED AFTER REPLACING THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923719 ↗
• MalfunctionDec 2, 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. IT WAS FOUND HAIR-LIKE FOREIGN OBJECTS INSIDE A PACKAGE IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE 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 23691841 ↗
• MalfunctionOct 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE NEEDLES AND SUTURES WERE DETACHED EASILY SEVERAL PACKAGES IN A ROW. THE NEEDLE-SUTURE CAME OFF WHEN THE NEEDLE WAS APPLIED TO THE MUSCLE LAYER AND REMOVED. THE EXACT QUANTITY IS UNKNOWN, SO THE SALES REP WOULD GET CONTACTED BY THE CUSTOMER LATER. 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. 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 23347747 ↗
• MalfunctionOct 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE NEEDLES AND SUTURES WERE DETACHED EASILY SEVERAL PACKAGES IN A ROW. THE NEEDLE-SUTURE CAME OFF WHEN THE NEEDLE WAS APPLIED TO THE MUSCLE LAYER AND REMOVED. THE EXACT QUANTITY IS UNKNOWN, SO THE SALES REP WOULD GET CONTACTED BY THE CUSTOMER LATER. 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. 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 23347746 ↗
• MalfunctionOct 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE NEEDLES AND SUTURES WERE DETACHED EASILY SEVERAL PACKAGES IN A ROW. THE NEEDLE-SUTURE CAME OFF WHEN THE NEEDLE WAS APPLIED TO THE MUSCLE LAYER AND REMOVED. THE EXACT QUANTITY IS UNKNOWN, SO THE SALES REP WOULD GET CONTACTED BY THE CUSTOMER LATER. 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. 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 23347739 ↗
• MalfunctionOct 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE NEEDLES AND SUTURES WERE DETACHED EASILY SEVERAL PACKAGES IN A ROW. THE NEEDLE-SUTURE CAME OFF WHEN THE NEEDLE WAS APPLIED TO THE MUSCLE LAYER AND REMOVED. THE EXACT QUANTITY IS UNKNOWN, SO THE SALES REP WOULD GET CONTACTED BY THE CUSTOMER LATER. 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. 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 23347738 ↗
• MalfunctionAug 22, 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 SUTURE WHICH IN ONE OUT OF THE CR WAS COME OFF FROM THE BEGINNING. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026127 ↗
• InjuryDec 17, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE AND THE WOUND WAS OPENED. IT IS UNKNOWN WHEN THE EVENT OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 13025486 ↗
• InjuryDec 17, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE AND THE WOUND WAS OPENED. IT IS UNKNOWN WHEN THE EVENT OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 13025484 ↗
• MalfunctionNov 29, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN TOTAL HYSTERECTOMY ON (B)(6) 2021 AND SUTURE WAS USED ON THE AREA AROUND THE PARAMETRIUM TO STOP BLEEDING. DURING THE PROCEDURE, WHEN THE NEEDLE WAS RETURNED TO A NURSE AFTER USING AROUND THE PARAMETRIUM BY INTERRUPTED SUTURING, THE NURSE NOTICED THAT THE NEEDLE TIP HAD BEEN BROKEN. AFTER THAT, THE NEEDLE TIP WAS SEARCHED, BUT IT COULD NOT BE FOUND. VISUAL INSPECTION, MANUAL EXPLORATION, AND X-RAY WERE PERFORMED, BUT THE NEEDLE TIP WAS NOT FOUND. IT IS POSSIBLE THAT THE NEEDLE TIP WAS BROKEN DURING THE OPERATION AND LEFT IN THE BODY. THERE WAS NO SPECIFIC HEALTH HAZARD. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THE PATIENT WAS EXPLAINED THE SITUATION. THE PATIENT HAD BEEN HOSPITALIZED AND THERE WAS NO PROBLEM AS OF (B)(6) 2021. THE SURGEON HAD COMMENTED THAT THERE ARE NO CONCRETE HEALTH PROBLEMS YET, BUT THE RISK REMAINS FOR THE FUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12888688 ↗
• MalfunctionDec 4, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A DIFFERENT PRODUCT CODE SUTURE WAS DISCOVERED IN THE BOX. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10950018 ↗
• MalfunctionJun 27, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS BROKEN AT THE BODY PART WHEN PULLING AFTER PASSING THE NEEDLE THROUGH THE TISSUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8741355 ↗

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