Coated VICRYL VCP340HRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10705031052499), received between Jun 25, 2019 and Aug 6, 2026 — classified as 3 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 6, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50164243 ↗
• MalfunctionAug 28, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY, IT WAS FOUND THAT THE SUTURE HAD BEEN FRAYED. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 22911078 ↗
• MalfunctionApr 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE LIGATURE WAS BROKEN SOMETIMES NEAR THE DEVICE. 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 21866895 ↗
• MalfunctionMar 13, 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 NEEDLE DETACHES FROM THE THREAD DURING PASSAGE THROUGH THE SKIN AND WHEN PULLING WITH MINIMAL EFFORT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894743 ↗
• MalfunctionMar 13, 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 NEEDLE DETACHES FROM THE THREAD DURING PASSAGE THROUGH THE SKIN AND WHEN PULLING WITH MINIMAL EFFORT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894742 ↗
• MalfunctionOct 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TLH: TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER APPLYING THE FIRST STITCH ON VAGINAL STUMP, DURING LIGATION, THE SUTURE WAS DETACHED FROM THE NEEDLE EVEN THOUGH NO TENSION WAS APPLIED. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950177 ↗
• MalfunctionAug 16, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT ROBOTIC ASSISTED LAPAROSCOPIC PARTIAL NEPHRECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS OPENED ONTO THE STERILE FIELD AND INITIAL OBSERVATION OF THE SUTURE DID NOT HAVE ANY APPARENT HOLES. AFTER THE SUTURE WAS OPENED IT WAS DISCOVERED THAT THE SUTURE PACKAGE HAD A SMALL HOLE IN IT. THE ERROR WAS RECOGNIZED QUICKLY, BUT THE FIELD WAS CONTAMINATED, AND SUPPLIES NEEDED TO BE OPENED TO MAINTAIN GOOD STERILE TECHNIQUE. THEY OPENED AN ADDITIONAL SUTURE, AN EXTRA PAIR OF GLOVES, AND REMNANTS OF IOBAN WAS USED. THIS ISSUE HAPPENED DURING A TIME IN THE CASE THAT WAS A LITTLE MORE INTENSE THAN OTHER TIMES. THEY HAD JUST FINISHED DISSECTING THE KIDNEY, THE KIDNEY WAS MOSTLY CLOSED, AND WERE FINISHING UP THE LAST BIT OF SUTURING LEFT ON THE KIDNEY. NO HARM WAS CAUSED TO THE PATIENT. NO FURTHER EVENT DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17556402 ↗
• MalfunctionApr 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE SUTURE JUST PASSED THROUGH TISSUE, THE SUTURE WAS BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828080 ↗
• MalfunctionNov 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE DETACHED FROM THE SUTURE DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15887953 ↗
• MalfunctionJul 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON AN UNKNOWN SUTURE AND SUTURE WAS USED. THE PRODUCT WAS USED FOR VAGINAL CUFF SUTURE. WHEN PULLING OUT THE NEEDLE AFTER SUTURING, ONLY THE TIP OF THE NEEDLE WAS GRASPED, AND THE NEEDLE TIP WAS BROKEN. THE NEEDLE TIP WAS VERY SMALL AND IT COULD NOT BE FOUND IN THE ABDOMINAL CAVITY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15026786 ↗
• InjuryFeb 7, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  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. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 13476836 ↗
• 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 13025489 ↗
• MalfunctionDec 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 13025482 ↗
• MalfunctionAug 30, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING, THE NEEDLE SNAPPED IN HALF. THE FRAGMENT WAS RETRIEVED AND A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12385885 ↗
• MalfunctionJun 28, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12080478 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROSTHESIS REPLACEMENT SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED ON THE JOINT CAPSULE BY INTERRUPTED SUTURING METHOD. THE LENGTH OF THE SURGICAL WOUND WAS 10 CM. EPIDERMIS WAS CLOSED WITH A SKIN STAPLER. ON (B)(6) 2020, THE SURGICAL WOUND GOT SWOLLEN AND BECAME RED, AND INFLAMMATION OCCURRED UNDER THE SKIN. ON (B)(6) 2020, TREATMENTS SUCH AS REOPENING THE WOUND AND DEBRIDEMENT WERE PERFORMED. RE-INCISION OF 15 CM LENGTH WAS PERFORMED. THE SUTURE WAS REMOVED. THE WOUND CLEANING WITH CLEANING SOLVENT INCLUDING VANCOMYCIN WAS PERFORMED. THEN, THE SURGICAL WOUND WAS CLOSED WITH NYLON SUTURE. IT WAS REPORTED THAT INFECTION DUE TO THE IMPLANT HAS NOT OCCURRED. CRP LEVEL DID NOT INCREASE. CULTIVATION WAS PERFORMED FOR THE TISSUE OF THE SURGICAL SITE AND THE SUTURE WHICH WAS TAKEN DURING DEBRIDEMENT. THE PATIENT HAS BEEN HOSPITALIZED AND IS BEING MONITORED. IT WAS ALSO REPORTED THAT THERE WAS NO ABSCESS CREATED OR OBSERVED. AS A RESULT OF CULTIVATION, (B)(6) WAS DETECTED. CLINDAMYCIN HAS BEEN ADMINISTERED BY INTRAVENOUS DRIP. THE DOCTOR COMMENTED THAT THE SUTURE WAS NOT THE CAUSE BECAUSE (B)(6) WAS DETECTED.

  Patient problems: Bacterial Infection; Erythema; Inflammation; Swelling/ Edema

  MAUDE report 10946757 ↗
• MalfunctionNov 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON CHECKED THE TIP OF THE NEEDLE-HOLDER BY A CAMERA, THERE WAS ONLY A SUTURE, AND NO NEEDLE WAS OBSERVED. THE ABDOMINAL CAVITY WAS SEARCHED, BUT THE NEEDLE COULD NOT BE FOUND. FINALLY, IT WAS FOUND THAT THE NEEDLE HAD BEEN CAUGHT ON THE SUBCUTIS OF THE WOUND. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THE LOT NUMBER IS UNKNOWN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10781637 ↗
• MalfunctionOct 22, 2020Material Separation; Material Separation

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

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

  MAUDE report 10719405 ↗
• MalfunctionOct 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON 10/09/2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 10719354 ↗
• MalfunctionOct 19, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10700414 ↗
• MalfunctionOct 19, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10700392 ↗
• MalfunctionDec 11, 2019Break; Inaccurate Information; Break; Inaccurate Information

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPIC OB-GYN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE BROKE WHILE TYING. THE PRODUCT WAS PACKED IN A DIFFERENT PACKAGE WHEN IT WAS RETURNED BY THE HOSPITAL. THUS, THE PRODUCT CODE INDICATED ON THE PACKAGE IS NOT THE SAME. THE LOT NUMBER IS UNKNOWN. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9454451 ↗
• MalfunctionJun 25, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAESAREAN SECTION ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN PULLING THE SUTURE DURING CONTINUOUS SUTURING ON THE FASCIA. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8730834 ↗
• MalfunctionJun 25, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CAESAREAN SECTION ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN PULLING THE SUTURE DURING CONTINUOUS SUTURING ON THE FASCIA. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8730833 ↗

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