Coated VICRYL VCP333H (UDI 10705031052390)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10705031052390), received between Apr 4, 2019 and Aug 17, 2026 — classified as 6 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50281006 ↗
• MalfunctionAug 17, 2026Material Separation

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. While tying the node, the suture detached easily. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280822 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CHILD DEVELOPED AND INFECTION AT THE SURGICAL SITE 15 DAYS AFTER SURGERY. THE PATIENT REQUIRED ANTIBIOTICS, THOROUGH SURGICAL CLEANING AND INCREASED FREQUENCY OF POST-OPERATIVE MEDICAL CONSULTATIONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Inflammation; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 24700098 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CHILD DEVELOPED AND INFECTION AT THE SURGICAL SITE 15 DAYS AFTER SURGERY. THE PATIENT REQUIRED ANTIBIOTICS, THOROUGH SURGICAL CLEANING AND INCREASED FREQUENCY OF POST-OPERATIVE MEDICAL CONSULTATIONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Inflammation; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 24700097 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CHILD DEVELOPED AND INFECTION AT THE SURGICAL SITE 15 DAYS AFTER SURGERY. THE PATIENT REQUIRED ANTIBIOTICS, THOROUGH SURGICAL CLEANING AND INCREASED FREQUENCY OF POST-OPERATIVE MEDICAL CONSULTATIONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Inflammation; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 24700095 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ACHILLES TENDON RUPTURE SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR SUBCUTANEOUS LIGATION. TAKUMI TAPE WAS ALSO USED. POST-OP, APPROXIMATELY TWO WEEKS AFTER THE ACHILLES TENDON RUPTURE REPAIR, AN INFLAMMATORY REACTION OCCURRED IN THE AFFECTED AREA, SO THE TAKUMI TAPE WAS REMOVED, BUT DEBRIS WAS SUBSEQUENTLY REPEATED. THE INFLAMMATION IN THE AFFECTED AREA WAS THOUGHT TO BE A TISSUE REACTION. THE PATIENT WAS OBSERVED AFTER REMOVING THE SUTURE, BUT IT WAS UNCLEAR WHETHER THE FIBERS HAD EMBEDDED THEMSELVES IN THE FASCIA OR SOMEWHERE, AND THE PATIENT DID NOT RECOVER, SO AN ACHILLES TENOTOMY WAS PERFORMED. SINCE THERE WAS ALSO SEVERE INFLAMMATION AROUND THE LIGATED SUTURE, THE ACHILLES TENDON WAS COMPLETELY EXCISED, THE SUTURE WAS REMOVED AND THEN THE SKIN WAS SUTURED WITH NYLON WITHOUT SUTURING THE SUBCUTANEOUS. IT HAS BEEN ONE WEEK NOW SINCE THE ACHILLES TENDON WAS REMOVED, AND THE STITCHES HAVE NOT YET BEEN REMOVED, SO THE PATIENT'S PROGRESS IS UNKNOWN. THERE ARE USUALLY NO PROBLEMS FOR ABOUT A WEEK AFTER SURGERY, BUT INFLAMMATION ON THE SKIN OCCURS 2 TO 4 WEEKS LATER. REGARDING THE CAUSE OF THIS INCIDENT, THE DOCTOR SAID THAT IT MAY

  Patient problems: Inflammation; Local Reaction

  MAUDE report 23303075 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED THAT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN TIED OR PULLED THE THREAD, THE SUTURE KEPT BREAKING. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES, ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913146 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED THAT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN TIED OR PULLED THE THREAD, THE SUTURE KEPT BREAKING. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES, ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913144 ↗
• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN STITCHING, THE SUTURE IS CUT REPEATEDLY, NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20176493 ↗
• MalfunctionSep 9, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE THREAD SEPARATES FROM THE NEEDLE. NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20176440 ↗
• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN STITCHING, THE SUTURE IS CUT REPEATEDLY, NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20176432 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL ENLARGEMENT ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE SUBCUTANEOUS DERMIS. IT WAS REPORTED THAT FOR THE SUBCUTANEOUS DERMIS, EPIDERMAL NYLON (BULLET NEEDLE, CROWNJUN¿S PRODUCT) WAS ALSO USED. POSTOPERATIVE REDNESS AND OTHER SYMPTOMS WERE OBSERVED, AND INFECTION OCCURRED EVENTUALLY. THE REDNESS OCCURRED A FEW DAYS AFTER SURGERY, POST-OP, IN THE WARD / ICU, THE PATIENT GOT INFECTED, AND A RE-OPERATION WAS PERFORMED ABOUT ONE WEEK AFTER THE SURGERY. AFTER REOPERATION, NEGATIVE PRESSURE CLOSURE THERAPY WAS DONE. IT WAS STATED THAT THE PATIENT WAS A BIT OF A FILTHY PATIENT, AND THIS WAS THE FIRST TIME OF THIS SURGERY IN THE HOSPITAL. THE SURGEON¿S OPINION ABOUT CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND EVENT WAS REPORTED AS NO. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 17666696 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED ON THE SUBCUTANEOUS TISSUE. THE PATIENT DEVELOPED AN INFECTION IN THE SUBCUTANEOUS LAYER. THE SURGEON CHANGED THEIR TECHNIQUE WITH TYPE OF NEEDLE. THE PATIENT DEVELOPED AN INFECTION. THE SSI IS NOT YET IDENTIFIED IF IT CAME FROM THE SUTURE, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 14992463 ↗
• MalfunctionJun 16, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14716766 ↗
• MalfunctionJun 16, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14716756 ↗
• MalfunctionJun 16, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14716382 ↗
• MalfunctionJun 16, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14716367 ↗
• MalfunctionJun 16, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14716345 ↗
• MalfunctionJun 6, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THIS ISN'T SOMETHING WE HAVE EXPERIENCED BEFORE. WHEN PULLING THE SUTURE TIGHT, IT SNAPS. THIS HAS HAPPENED TO MORE THAN ONE OF MY VETERINARIANS ON MORE THAN ONE OCCASION. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14608393 ↗
• MalfunctionNov 2, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2020; AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10771422 ↗
• MalfunctionNov 2, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2020; AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10771413 ↗
• MalfunctionSep 17, 2020Material Separation; Material Separation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10546338 ↗
• MalfunctionJul 21, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10304603 ↗
• MalfunctionApr 4, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURE BREAKAGE OCCURRED DURING SUTURE PROCESS. CHANGED ANOTHER ONE TO COMPLETE SURGERY. THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8484745 ↗

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