Coated VICRYL VCP346H (UDI 10705031052574)Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10705031052574), received between Apr 12, 2019 and Aug 25, 2026 — classified as 3 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Break” (44 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 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50441879 ↗
• MalfunctionAug 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286861 ↗
• MalfunctionAug 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286848 ↗
• MalfunctionAug 5, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50141364 ↗
• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. ON THE AFTERNOON, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE SURGERY. THE NURSE IMMEDIATELY REPLACED THE SUTURE WITH A NEW ONE AND COMPLETED THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931697 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EMERGENCY C-SECTION PROCEDURE ON (B)(6) 2026 SUTURE WAS USED. DURING THE CLOSURE OF THE ABDOMINAL MUSCLE BAND OF A CAESAREAN SECTION, THE FIRST OPERATOR REALIZED THAT THE NEEDLE IN USE WAS MISSING THE LAST PART AS CAN BE SEEN FROM THE ATTACHED PHOTO. THE NEEDLE IN QUESTION IS A 0 CT-1 . INTRAOPERATIVELY, AN ABDOMINAL X-RAY WAS MADE ON THE PATIENT TO SEARCH FOR THE MISSING TIP OF THE NEEDLE WHICH WAS NEGATIVE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793594 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED ON THE TISSUE. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL THREE PRODUCTS HAD SUTURE BREAKAGE ISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421025 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED ON THE TISSUE. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL THREE PRODUCTS HAD SUTURE BREAKAGE ISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421022 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED ON THE TISSUE. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL THREE PRODUCTS HAD SUTURE BREAKAGE ISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24420986 ↗
• MalfunctionJan 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, AT 14:42, A GYNECOLOGIST USED SUTURE TO SUTURE THE PATIENT'S UTERINE MUSCLE LAYER. WHEN THE DOCTOR APPLIED NORMAL SUTURE TENSION FOR PULLING, THE SUTURE BROKE, RESULTING IN AN UNEXPECTED INTERRUPTION OF THE SUTURE OPERATION. THE OPERATOR IMMEDIATELY STOPPED THE OPERATION, CONFIRMED THE SURGERY AND RULED OUT THE RISK OF RESIDUAL BROKEN SUTURE ENDS, DISCARDED THE BROKEN SUTURE, AND USED A NEW SUTURE OF THE SAME MODEL THAT HAD BEEN VERIFIED TO BE INTACT TO COMPLETE THE SUBSEQUENT SUTURING, ULTIMATELY ENSURING THE CLOSURE OF THE SURGICAL INCISION. THE RISK OF SUTURE RUPTURE DURING UTERINE SUTURING IS MUCH HIGHER THAN IN OTHER PARTS, WHICH MAY LEAD TO CATASTROPHIC CONSEQUENCES. THE UTERINE WALL HAS AN EXTREMELY ABUNDANT BLOOD SUPPLY. IF THE RUPTURE OCCURS AT A CRITICAL HEMOSTATIC SUTURE POINT OR CAUSES THE SUTURE TO LOOSEN AS A WHOLE, IT MAY CAUSE UNCONTROLLABLE UTERINE BLEEDING, LEADING TO HEMORRHAGIC SHOCK IN A SHORT PERIOD OF TIME AND ENDANGERING THE PATIENT'S LIFE. THE INTERRUPTION OF SUTURING DISRUPTS THE CONTINUITY AND TENSION BALANCE OF THE INCISION, ESPECIALLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24119477 ↗
• MalfunctionSep 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OB PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE DURING OB PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22967900 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SURGEON FOUND VCP346H SUTURE BREAK WHEN THEY PULLED IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330205 ↗
• MalfunctionMar 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT DURING A C-SECTION CLOSURE, A NEEDLE BROKE OFF UNEXPECTEDLY FROM THE SUTURE. THE NEEDLE WAS RECOVERED, AND THE CASE WAS COMPLETED WITHOUT ANY PROBLEMS. ANOTHER SUTURE WAS OPENED AND USED. PROCEDURE WAS COMPLETED WITHOUT ANY SURGICAL DELAY. DEVICE WAS NOT RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21565959 ↗
• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2025 AND SUTURE WAS USED. DURING A C-SECTION PROCEDURE THAT THREE SUTURES BROKE. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO PRODUCT RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446057 ↗
• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2025 AND SUTURE WAS USED. DURING A C-SECTION PROCEDURE THAT THREE SUTURES BROKE. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO PRODUCT RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446055 ↗
• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2025 AND SUTURE WAS USED. DURING A C-SECTION PROCEDURE THAT THREE SUTURES BROKE. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO PRODUCT RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446053 ↗
• MalfunctionNov 26, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT DURING INCOMING GOODS CHECKING, THERE WERE TWO PACKAGES OF PRODUCTS LESS THAN EXPECTED IN THE BOX WHEN JUST OPENED. THERE SHOULD BE THIRTY-SIX PACKAGES OF PRODUCTS IN THE BOX, BUT ACTUALLY THERE WERE ONLY THIRTY-FOUR PACKAGES OF PRODUCTS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20780271 ↗
• MalfunctionOct 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE (AMPUTATION STUMP CLOSURE) ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE THREAD WAS DETACHED FROM THE NEEDLE DURING CLOSURE INTRA-OP WHILE CLOSING THE STUMP. THE CASE IS LEG AMPUTATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515137 ↗
• MalfunctionAug 21, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018334 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND 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. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917442 ↗
• MalfunctionJun 11, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN ELECTIVE CESAREAN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. IN 2ND PREGNANT 0 PARA AT 39 WEEKS FOR PREVIOUS LAPAROTOMIC MYOMECTOMY. DURING, THE SURGEON FOUND AFTER REGULAR SUTURE OF THE MUSCLE BANDS, THE ABOVEMENTIONED BANDS REOPENED IN THE MEDIAL PORTION DUE TO A BROKEN SUTURE, WITH INTACT ANGULAR ENDS. THEREFORE, IT WAS NECESSARY TO REMOVE THE ENTIRE SUTURE AND THEN PERFORM ADDITIONAL SUTURES WITH THE SAME THREAD OF DIFFERENT LOT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509909 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19492054 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERO-POSTERO VAGINAL REPAIR, PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE HAVE BEEN CUT-OFF FROM THE TIP 1MM LENGTH. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19136381 ↗
• MalfunctionMar 19, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE THE SURGEON WAS SUTURING THE WOUND. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18934889 ↗
• MalfunctionMar 19, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. TWO SUTURES WERE DISASSEMBLED DURING THE PROCEDURE. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932134 ↗

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