Coated VICRYL VCP397H (UDI 10705031052970)Recalls & reported problems

Summary

The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 10705031052970), received between Jul 12, 2018 and Sep 25, 2026 — classified as 16 injuries, 114 malfunctions.

The most frequently reported specific device problem is “Break” (61 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 25 most recent of 130 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902777 ↗
• MalfunctionSep 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902429 ↗
• MalfunctionAug 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255036 ↗
• MalfunctionJun 4, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SCECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 9:50, THE DOCTOR PERFORMED SURGERY ON THE PATIENT. THE DOCTOR USED SUTURE TO SUTURE THE PATIENT'S SKIN, AND AFTER THE FIRST NEEDLE WAS INSERTED, THE SUTURE WAS PULLED BACK. WHEN PULLED BACK, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE DOCTOR REPLACED THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394875 ↗
• MalfunctionMay 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2026 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 15:30, THE DOCTOR PERFORMED INTRADERMAL SUTURING ON THE PARTURIENT. AT THE CLOSING STAGE, THE SUTURE SUDDENLY BROKE AND COULD NOT BE KNOTTED FOR SUTURING. IMMEDIATELY REPLACED THE SUTURE AND 2 STITCHES WERE ADDED TO CLOSE THE INCISION PROPERLY. THE INCISION WAS WELL ALIGNED AND THERE WAS NO BLEEDING. EXTENDED THE SUTURE TIME AND INCREASED THE CHANCE OF INFECTION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25127341 ↗
• MalfunctionMay 6, 2026Break; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCESS OF SUTURING THE PERINEAL INTRADERMAL SUTURE FOR THE PATIENT, THE DOCTOR FOUND THAT THE SUTURE AT THE END OF THE SUTURE HAD BURRS AND PARTIALLY BROKEN, AND WAS NOT COMPLETELY DISCONNECTED. UPON DISCOVERY, AN IMMEDIATE EVALUATION WAS CONDUCTED. AS THE SUTURE WAS NEARING COMPLETION AND DID NOT AFFECT NORMAL USE, THERE WAS NO NEED TO REINFORCE OR REMOVE THE WOUND FOR RE SUTURING. AFTER TYING IT UP, A PHOTO WAS TAKEN AS EVIDENCE AND REPORTED TO THE HEAD NURSE . ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092600 ↗
• MalfunctionMay 5, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING THE SKIN DURING SURGERY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE SURGEON ACTED SOFTLY AND WITHOUT VIOLENT OPERATION, AND REPLACED IT WITH A NEW ONE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085510 ↗
• MalfunctionApr 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 11:30 AM, AFTER PERFORMING SURGERY ON THE PATIENT AND CLOSING THE ABDOMINAL CAVITY, THE DOCTOR USED SUTURE TO SUTURE THE PATIENT'S SKIN. NORMALLY, THE FIRST STITCH FOR SUTURING THE SKIN WAS GENTLY PULLED BACK, AND THE TAIL OF THE NEEDLE WAS COMPLETELY SEPARATED FROM THE SUTURE CONNECTION WHEN PULLED BACK. THE DOCTOR IMMEDIATELY REPLACED ANOTHER NEEDLE AND SUTURE FOR SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044279 ↗
• MalfunctionApr 20, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AT 9:50 AM, AFTER SUTURING THE FIRST STITCH OF THE SKIN LAYER DURING SURGERY, THE 2CM SUTURE CONNECTED TO THE NEEDLE BECAME ROUGH AND COULD NOT CONTINUE TO BE SUTURED CONTINUOUSLY. IMMEDIATELY REPLACED WITH NEW SUTURE TO CONTINUE SUTURING. DURING THIS PERIOD, THE SURGERY TIME WAS EXTENDED, INCREASING THE RISK OF INFECTION FOR PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24929845 ↗
• MalfunctionApr 16, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO "ACUTE CESAREAN SECTION DELIVERY". ON THE 11TH DAY AFTER SURGERY, THE PATIENT ENTERED THE OPERATING ROOM FOR SURGERY. AT THE END OF THE SURGERY, SUTURE WORK WAS CARRIED OUT. WHEN THE SUTURE WAS HALFWAY THROUGH, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND THE DOCTOR IMMEDIATELY REPLACED IT WITH A NEW SUTURE OF THE SAME SPECIFICATION AND BATCH NUMBER. THE SURGICAL SUTURE WORK WAS SUCCESSFULLY COMPLETED. AFTERWARDS, IT WAS LEARNED FROM THE SURGEON THAT ALTHOUGH THERE WAS A NEEDLE HOLDER, THERE WERE OBJECTIVE SITUATIONS OF UNSTABLE NEEDLE HOLDING OR EXCESSIVE FORCE, ESPECIALLY WHEN THE FINE NEEDLE WAS PRONE TO BOUNCING OFF, CAUSING THE NEEDLE TO FALL INTO THE PATIENT'S BODY OR THE RISK OF NEEDLE PUNCTURE AND INFECTION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895028 ↗
• MalfunctionApr 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 12:20, THE PATIENT UNDERWENT SURGERY AND NEEDED TO SUTURE THE SKIN. THE DOCTOR USED THE SUTURE AND CHECKED IT BEFORE USE. THE NEEDLE WAS HELD BY A NEEDLE HOLDER WITHOUT PULLING IT FORCEFULLY. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND COULD NOT BE USED. THE DOCTOR REPLACED IT WITH A NEW NEEDLE TO COMPLETE THE SUTURE. IF IT FALLS OFF DURING THE SURGERY, IT WILL PROLONG THE SURGERY TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887059 ↗
• MalfunctionApr 8, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOWER SEGMENT CESAREAN SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 3:35 PM, THE PATIENT UNDERWENT SURGERY. DURING THE PROCESS OF SUTURING THE INCISION, WHEN THE CHIEF SURGEON WAS SUTURING THE FIRST STITCH OF THE PATIENT'S SKIN LAYER, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND COULD NOT CONTINUE TO BE SUTURED CONTINUOUSLY. THE DOCTOR IMMEDIATELY REPLACED THE SUTURE WITH A NEW ONE AND CONTINUED SUTURING AT THE INCISION SITE. THIS PROCESS PROLONGS THE SUTURING TIME AND INCREASES THE CHANCE OF INCISION INFECTION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818969 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROID PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE COULD NOT BE WITHDRAWN WHEN REMOVING SUTURE AFTER SURGERY. SOME SUTURE REMAINED IN BODY, LEADING TO SIGNIFICANT SCAR HYPERPLASIA. THE CUSTOMER REPORTED THAT MULTIPLE INCIDENTS HAD OCCURRED, BUT THE EXACT NUMBER COULD NOT BE CONFIRMED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Scar Tissue; Swelling/ Edema

  MAUDE report 24393381 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROID PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE COULD NOT BE WITHDRAWN WHEN REMOVING SUTURE AFTER SURGERY. SOME SUTURE REMAINED IN BODY, LEADING TO SIGNIFICANT SCAR HYPERPLASIA. THE CUSTOMER REPORTED THAT MULTIPLE INCIDENTS HAD OCCURRED, BUT THE EXACT NUMBER COULD NOT BE CONFIRMED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Scar Tissue; Swelling/ Edema

  MAUDE report 24393371 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROID PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE COULD NOT BE WITHDRAWN WHEN REMOVING SUTURE AFTER SURGERY. SOME SUTURE REMAINED IN BODY, LEADING TO SIGNIFICANT SCAR HYPERPLASIA. THE CUSTOMER REPORTED THAT MULTIPLE INCIDENTS HAD OCCURRED, BUT THE EXACT NUMBER COULD NOT BE CONFIRMED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Scar Tissue; Swelling/ Edema

  MAUDE report 24393341 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROID PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE COULD NOT BE WITHDRAWN WHEN REMOVING SUTURE AFTER SURGERY. SOME SUTURE REMAINED IN BODY, LEADING TO SIGNIFICANT SCAR HYPERPLASIA. THE CUSTOMER REPORTED THAT MULTIPLE INCIDENTS HAD OCCURRED, BUT THE EXACT NUMBER COULD NOT BE CONFIRMED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Scar Tissue; Swelling/ Edema

  MAUDE report 24393263 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROID TUMOR RESECTION SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGERY AND SUTURE WAS USED DURING THE SURGERY. A FEW DAYS LATER, WHEN THE PATIENT CAME TO THE HOSPITAL TO HAVE THE SUTURE REMOVED, IT WAS FOUND THAT THE SUTURE COULD NOT BE EXTRACTED AND SOME OF THE SUTURE REMAINED. IT WILL LEAD TO SIGNIFICANT SCAR HYPERPLASIA IN PATIENTS. IF THE SUTURE IS COMPLETELY REMOVED, THE SCAR HYPERPLASIA IN THE WOUND WILL DECREASE, AND THE SCAR HYPERPLASIA WILL SIGNIFICANTLY AFFECT THE PATIENT'S APPEARANCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Scar Tissue; Swelling/ Edema

  MAUDE report 24393166 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROID TUMOR RESECTION SURGERY ON (B)(6)2025 AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGERY AND SUTURE WAS USED DURING THE SURGERY. A FEW DAYS LATER, WHEN THE PATIENT CAME TO THE HOSPITAL TO HAVE THE SUTURE REMOVED, IT WAS FOUND THAT THE SUTURE COULD NOT BE EXTRACTED AND SOME OF THE SUTURE REMAINED. IT WILL LEAD TO SIGNIFICANT SCAR HYPERPLASIA IN PATIENTS. IF THE SUTURE IS COMPLETELY REMOVED, THE SCAR HYPERPLASIA IN THE WOUND WILL DECREASE, AND THE SCAR HYPERPLASIA WILL SIGNIFICANTLY AFFECT THE PATIENT'S APPEARANCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Scar Tissue; Swelling/ Edema

  MAUDE report 24388096 ↗
• MalfunctionJan 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGERY, SUTURE WAS USED TO SUTURE THE SKIN LAYER. AFTER PULLING AND PULLING THE SUTURE, THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED. 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 24223525 ↗
• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE DOCTOR FOUND THAT THE SUTURE WAS ABOUT TO BREAK (THERE WAS STILL A TRACE OF CONNECTION) 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 24147833 ↗
• MalfunctionDec 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR "PREGNANCY COMPLICATED WITH UTERINE SCARS". DURING THE SURGERY, WHEN USING SUTURE TO SUTURE THE SKIN, THE NEEDLE PULL OFF ISSUE HAPPENED AFTER SEVERAL STITCHES. REPLACED THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706946 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOWER SEGMENT CESAREAN SECTION SURGERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT ENTERED THE OPERATING ROOM FOR SURGERY AT 8:55, DURING THE PROCESS OF SUTURING THE WOUND, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THEREFORE, A NEW SUTURE OF THE SAME ORIGIN, BATCH, AND MODEL WAS IMMEDIATELY REPLACED TO SUCCESSFULLY COMPLETE THE SURGERY. AFTER CAREFUL OBSERVATION OF THE PROBLEMATIC PRODUCT, IT WAS FOUND THAT NEEDLE PULL OFF ISSUE WAS CAUSED BY THE BREAKAGE OF THE NEEDLE HOLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619613 ↗
• MalfunctionNov 5, 2025Failure to Degrade; Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE AND SUTURE WAS USED. POST-OP, ON (B)(6) 2025 THE MIDWIFE SUTURED THE SIDE INCISION FOR THE PATIENT AFTER DELIVERY. AFTER SUTURING, THE SIDE INCISION WAS PAINFUL AND THE SUTURE WAS NOT ABSORBED. REMOVED THE SUTURE, RINSE AND DISINFECT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Pain

  MAUDE report 23479042 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DELIVERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT GAVE BIRTH TO A LIVE BABY AND UNDERWENT A LATERAL EPISIOTOMY. WHEN THE SUTURE WAS COMPLETED AND KNOTTED, THE SUTURE BROKE. DUE TO THE SWELLING OF THE PERINEUM, THE KNOTTING WAS LIGHT AND THERE WAS NO NEED TO FORCEFULLY PULL IT APART. REPLACED THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23458118 ↗
• MalfunctionJul 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DELIVERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AT 7:05, DURING PERINEAL SUTURING PERFORMED BY THE MIDWIFE AFTER DELIVERY, IT WAS FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE SUTURE WAS IMMEDIATELY REPLACED TO CONTINUE PERINEAL SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22510259 ↗

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