Coated VICRYL VCP602HRecalls & reported problems

Summary

The FDA's MAUDE database contains 156 adverse event reports that list this exact device (DI 10705031054370), received between May 9, 2019 and Sep 29, 2026 — classified as 3 injuries, 153 malfunctions.

The most frequently reported specific device problem is “Material Separation” (96 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 156 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Separation

  It was reported that a patient underwent an unknown laparoscopic procedure on an unknown date and suture was used. During surgery, the suture was detached from the needle when the suture was placed at the umbilical port insertion site. Apparently, it came off without any force being applied. It was not a control release needle. Additional suture was performed to complete the case. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934365 ↗
• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861436 ↗
• MalfunctionAug 31, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533155 ↗
• MalfunctionAug 24, 2026Material Separation

  It was reported that a patient underwent a Laparoscopy procedure on (b)(6) 2026 and suture was used. When the doctor used suture to suture the incision, the needle pull off issue happened. The suture was replaced to successfully suture the incision. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50412270 ↗
• MalfunctionAug 14, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254858 ↗
• MalfunctionJun 10, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE NEEDLE WAS BROKEN WHEN THE PACKAGE WAS OPENED. THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT 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 25462542 ↗
• MalfunctionMay 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGERY DUE TO ECTOPIC PREGNANCY. WHILE USING SUTURE TO CLOSE THE ABDOMEN, THE NEEDLE PULL OFF ISSUE SUDDENLY HAPPENED. THE OPERATION WAS IMMEDIATELY STOPPED, AND OTHER SUTURES OF THE SAME SIZE WERE REPLACED TO CONTINUE THE SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150294 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SUTURE WAS BROKEN DURING LIGATION. IT WAS NOT 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 25058430 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED 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 25056045 ↗
• MalfunctionMay 1, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. WHEN USING SUTURE TO SUTURE AN INCISION, THE NEEDLE PULL OFF ISSUE HAPPENED. AFTER REMOVING THE SUTURE AND THE INTACT NEEDLE, THE SAME TYPE OF SUTURE WAS USED TO CONTINUE SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055987 ↗
• MalfunctionApr 28, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY AFTER USING ONE STITCH AND PULLING. THE DOCTOR SAID IT WAS STRANGE LIKE A CONTROL RELEASE HAD COME OFF. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015213 ↗
• MalfunctionApr 27, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A 3D LAPAROSCOPIC PARTIAL DUODENECTOMY PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGERY, AND THE SURGERY PROCESS WAS SMOOTH. WHEN SUTURE WAS USED TO CLOSE THE SURGICAL INCISION, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND COULD NOT BE USED, SO IT WAS REPLACED WITH A NEW ONE AND WAS USED NORMALLY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24998877 ↗
• MalfunctionApr 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EMERGENCY LAPAROSCOPIC APPENDECTOMY ON (B)(6) 2026 AND SUTURE WAS USED. THE PATIENT WALKED INTO THE HOSPITAL AT 9:10 AM DUE TO "ABDOMINAL PAIN FOR 6 HOURS". AFTER EXAMINATION, THE DIAGNOSIS WAS "ACUTE APPENDICITIS" AND SURGERY WAS REQUIRED. DURING THE SURGERY, WHEN THE DOCTOR WAS SUTURING THE WOUND FOR THE PATIENT, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, PROLONGING THE PATIENT'S TREATMENT TIME. THE DOCTOR IMMEDIATELY REPLACED ANOTHER SUTURE AND SUCCESSFULLY SUTURED THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966884 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN TYING POSITIVE OR NEGATIVE KNOTS. EVEN TYING THE FIRST KNOT, THE SUTURE BROKE. THE HCP RAISED ISSUE REGARDING THE STRENGTH OF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24939605 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN TYING POSITIVE OR NEGATIVE KNOTS. EVEN TYING THE FIRST KNOT, THE SUTURE BROKE. THE HCP RAISED ISSUE REGARDING THE STRENGTH OF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24939604 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN TYING POSITIVE OR NEGATIVE KNOTS. EVEN TYING THE FIRST KNOT, THE SUTURE BROKE. THE HCP RAISED ISSUE REGARDING THE STRENGTH OF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24939603 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE SUTURE WAS USED. A TOTAL OF 2 PRODUCTS OCCURRED WHERE THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. 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 24824145 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE SUTURE WAS USED. A TOTAL OF 2 PRODUCTS OCCURRED WHERE THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. 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 24824137 ↗
• MalfunctionMar 25, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN LAPAROSCOPY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. ON THE AFTERNOON, THE DOCTOR COMPLETED THE SURGERY AND DURING THE PROCESS OF SUTURING THE SKIN, THE SUTURE BROKE AT THE END OF THE NEEDLE. THE DOCTOR IMMEDIATELY REPLACED THE SUTURE AND CONTINUED SUTURING THE SKIN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694400 ↗
• MalfunctionMar 24, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AT 10:42, DURING THE OPERATION, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED BEFORE TYING THE KNOT WHILE SUTURING THE PATIENT. THE DOCTOR CHANGED THE SUTURE USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24682623 ↗
• MalfunctionMar 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP APPENDECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SURGICAL SUTURING PROCESS FOR THE PATIENT, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND THE NEEDLE WAS REPLACED TO CONTINUE THE SURGERY. THE INCIDENT RESULTED IN A PROLONGED SURGICAL TIME FOR THE PATIENT AND INCREASED SURGICAL RISKS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664224 ↗
• MalfunctionMar 4, 2026Material 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 24506745 ↗
• MalfunctionMar 4, 2026Material 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 24506700 ↗
• MalfunctionFeb 18, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN ROBOT-ASSISTED SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. THE PACKAGE WAS OPENED IN THE OPERATING ROOM AND TRIED TO USE THE PRODUCT, IT WAS FOUND THAT THE SUTURE AND THE NEEDLE WERE DETACHED. IT WAS NOT 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24380609 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING LIGATION, TWO SUTURES WERE BROKEN IN A ROW. IT WAS NOT 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. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323481 ↗

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