Coated VICRYL VCP741DRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10705031055216), received between Dec 21, 2020 and Aug 25, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Material Separation” (16 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A BIPOLAR HIP ARTHROPLASTY, ABOUT FOUR SUTURES NEAR THE CENTER WERE BROKEN DURING USE IN EMERGENCY SURGERY. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883611 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A BIPOLAR HIP ARTHROPLASTY, ABOUT FOUR SUTURES NEAR THE CENTER WERE BROKEN DURING USE IN EMERGENCY SURGERY. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883564 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A BIPOLAR HIP ARTHROPLASTY, ABOUT FOUR SUTURES NEAR THE CENTER WERE BROKEN DURING USE IN EMERGENCY SURGERY. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883530 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A BIPOLAR HIP ARTHROPLASTY, ABOUT FOUR SUTURES NEAR THE CENTER WERE BROKEN DURING USE IN EMERGENCY SURGERY. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883529 ↗
• MalfunctionMar 12, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROTID GLAND TUMOR EXCISION PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. AFTER OPENING THE PACKAGE, THERE WAS A TRASH LIKE A LINT WHICH COULD NOT BE REMOVED ON THE SUTURE. THE PRODUCT INVOLVED WAS NOT USED BY A JUDGMENT OF THE DOCTOR AND OPENED ANOTHER ONE. IT WAS A CONTROL RELEASE NEEDLE. THE PRODUCT WAS NOT USED FOR THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587819 ↗
• MalfunctionSep 11, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE IN HALF DURING CLOSING. THEY WERE ABLE TO OBTAIN BOTH PARTS. THE BROKEN NEEDLE IS WITH SURGICAL PATHOLOGY CURRENTLY. PATIENT CONSEQUENCES UNKNOWN. SURGICAL DELAY UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192061 ↗
• MalfunctionOct 4, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE WHEN PASSING THE NEEDLE THROUGH THE MUSCLE LAYER. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568204 ↗
• MalfunctionOct 4, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE WHEN PASSING THE NEEDLE THROUGH THE MUSCLE LAYER. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568201 ↗
• MalfunctionOct 4, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE WHEN PASSING THE NEEDLE THROUGH THE MUSCLE LAYER. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568200 ↗
• MalfunctionAug 30, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PASSING THE NEEDLE THROUGH THE MUSCLE LAYER, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PACKAGE WAS OPENED, BUT THE SAME ISSUE OCCURRED, SO ANOTHER BOX WAS USED FOR THE SURGERY. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO SAMPLE WILL BE RETURNED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389366 ↗
• MalfunctionAug 30, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PASSING THE NEEDLE THROUGH THE MUSCLE LAYER, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PACKAGE WAS OPENED, BUT THE SAME ISSUE OCCURRED, SO ANOTHER BOX WAS USED FOR THE SURGERY. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO SAMPLE WILL BE RETURNED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389365 ↗
• MalfunctionAug 9, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHILE PASSING THE NEEDLE INTO THE FASCIA, THE NEEDLE CAME OUT EMPTY AND THE SUTURE CAME OFF IN THE FASCIA BEFORE THE DOCTOR POPPED IT OFF. THIS OCCURRED ON THE THIRD PASS OF THE SUTURE. THE PROCEDURE WAS DELAYED BY FIVE MINUTES, BUT SUCCESSFULLY COMPLETED USING A NEW LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293261 ↗
• MalfunctionAug 9, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHILE PASSING THE NEEDLE INTO THE FASCIA, THE NEEDLE CAME OUT EMPTY AND THE SUTURE CAME OFF IN THE FASCIA BEFORE THE DOCTOR POPPED IT OFF. THIS OCCURRED ON THE THIRD PASS OF THE SUTURE. THE PROCEDURE WAS DELAYED BY FIVE MINUTES, BUT SUCCESSFULLY COMPLETED USING A NEW LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293165 ↗
• MalfunctionAug 9, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHILE PASSING THE NEEDLE INTO THE FASCIA, THE NEEDLE CAME OUT EMPTY AND THE SUTURE CAME OFF IN THE FASCIA BEFORE THE DOCTOR POPPED IT OFF. THIS OCCURRED ON THE THIRD PASS OF THE SUTURE. THE PROCEDURE WAS DELAYED BY FIVE MINUTES, BUT SUCCESSFULLY COMPLETED USING A NEW LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293096 ↗
• MalfunctionAug 9, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHILE PASSING THE NEEDLE INTO THE FASCIA, THE NEEDLE CAME OUT EMPTY AND THE SUTURE CAME OFF IN THE FASCIA BEFORE THE DOCTOR POPPED IT OFF. THIS OCCURRED ON THE THIRD PASS OF THE SUTURE. THE PROCEDURE WAS DELAYED BY FIVE MINUTES, BUT SUCCESSFULLY COMPLETED USING A NEW LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293058 ↗
• MalfunctionJul 13, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. WHILE PASSING THE NEEDLE INTO THE FASCIA, THE NEEDLE CAME OUT EMPTY AND THE SUTURE CAME OFF IN THE FASCIA BEFORE THE DOCTOR POPPED IT OFF. THIS OCCURRED ON THE THIRD PASS OF THE SUTURE. THE PROCEDURE WAS DELAYED BY FIVE MINUTES, BUT SUCCESSFULLY COMPLETED USING A NEW LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163182 ↗
• MalfunctionJul 13, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. WHILE PASSING THE NEEDLE INTO THE FASCIA, THE NEEDLE CAME OUT EMPTY AND THE SUTURE CAME OFF IN THE FASCIA BEFORE THE DOCTOR POPPED IT OFF. THIS OCCURRED ON THE THIRD PASS OF THE SUTURE. THE PROCEDURE WAS DELAYED BY FIVE MINUTES, BUT SUCCESSFULLY COMPLETED USING A NEW LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163176 ↗
• MalfunctionJul 13, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. WHILE PASSING THE NEEDLE INTO THE FASCIA, THE NEEDLE CAME OUT EMPTY AND THE SUTURE CAME OFF IN THE FASCIA BEFORE THE DOCTOR POPPED IT OFF. THIS OCCURRED ON THE THIRD PASS OF THE SUTURE. THE PROCEDURE WAS DELAYED BY FIVE MINUTES, BUT SUCCESSFULLY COMPLETED USING A NEW LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163171 ↗
• MalfunctionJul 13, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. WHILE PASSING THE NEEDLE INTO THE FASCIA, THE NEEDLE CAME OUT EMPTY AND THE SUTURE CAME OFF IN THE FASCIA BEFORE THE DOCTOR POPPED IT OFF. THIS OCCURRED ON THE THIRD PASS OF THE SUTURE. THE PROCEDURE WAS DELAYED BY FIVE MINUTES, BUT SUCCESSFULLY COMPLETED USING A NEW LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163164 ↗
• MalfunctionJul 13, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. WHILE PASSING THE NEEDLE INTO THE FASCIA, THE NEEDLE CAME OUT EMPTY AND THE SUTURE CAME OFF IN THE FASCIA BEFORE THE DOCTOR POPPED IT OFF. THIS OCCURRED ON THE THIRD PASS OF THE SUTURE. THE PROCEDURE WAS DELAYED BY FIVE MINUTES, BUT SUCCESSFULLY COMPLETED USING A NEW LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163156 ↗
• MalfunctionJul 13, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. WHILE PASSING THE NEEDLE INTO THE FASCIA, THE NEEDLE CAME OUT EMPTY AND THE SUTURE CAME OFF IN THE FASCIA BEFORE THE DOCTOR POPPED IT OFF. THIS OCCURRED ON THE THIRD PASS OF THE SUTURE. THE PROCEDURE WAS DELAYED BY FIVE MINUTES, BUT SUCCESSFULLY COMPLETED USING A NEW LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163152 ↗
• MalfunctionDec 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CHEST SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11050409 ↗

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