Syneture VLOCN0346Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521762527), received between Nov 23, 2021 and Aug 6, 2025 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC GASTRIC BYPASS, WHEN SUTURING, THE SUTURE BROKE AT THE WELD WITH THE FIRST PASS, DESPITE THERE BEING NO TENSION ON IT WHEN IT BROKE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731511 ↗
• MalfunctionJan 23, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219583 ↗
• InjurySep 20, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE A CRUROPLASTY FUNDOPLICATION PERFORMED LAST APRIL, THE PATIENT WAS RE-ADMITTED INTO THE HOSPITAL BECAUSE THE PATIENT HAD A NARROWING OF THE ESOPHAGUS AND SCAR TISSUE FORMATION AROUND THE SUTURE.

  Patient problems: Scar Tissue

  MAUDE report 20274626 ↗
• MalfunctionSep 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE VAGINAL CUFF, THE THREE SUTURE WAS BROKEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146276 ↗
• MalfunctionSep 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE VAGINAL CUFF, THE THREE SUTURE WAS BROKEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146221 ↗
• MalfunctionSep 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE VAGINAL CUFF, THE THREE SUTURE WAS BROKEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146053 ↗
• InjurySep 15, 2023Break; Material Frayed; Unraveled Material; Break; Material Frayed; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO AN OPEN EPIGASTRIC HERNIA AND UMBILICAL HERNIA REPAIR, PATIENT WAS RETURNED TO THE HOSPITAL FOR REOPERATION THE NEXT DAY AS AN EMERGENCY DUE TO WOUND DEHISCENCE. IN OPERATING ROOM AT THE RE-EXPLORATION, THE SUTURE LAYER WAS FOUND TO BE FRAGMENTED INTO MULTIPLE PIECES ALONG THE ENTIRE LENGTH OF THE WOUND INVOLVING BOTH SUTURES. NO TISSUE CUT THROUGH OF THE SUTURE WAS EVIDENT. THE SUTURE FRAGMENTS WERE REMOVED, AND TWO LENGTHS OF SUTURE WERE USED FOR EACH HALF OF THE DEFECT TO CLOSE THE LINEA ALBA AFTER A VENTRAL INCISIONAL HERNIA REPAIR OVER A NARROW MESH PATCH. THE INCISION WAS EXTENDED MORE THAN 1 INCH. THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Tissue Breakdown; Wound Dehiscence

  MAUDE report 17760604 ↗
• InjuryNov 17, 2022Labelling, Instructions for Use or Training Problem; Adverse Event Without Identified Device or Use Problem; Labelling, Instructions for Use or Training Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, WHEN THE STAFF PULLED THE SUTURE ASKED FOR BY THE PROVIDER, THE NON-ABSORBABLE VERSION OF THE SAME BRAND WAS PULLED, AND IT WAS NOTED THAT THE PROVIDER USED THE INCORRECT SUTURE ON THE PATIENT REQUIRING A RETURN TO SURGERY TO REMOVE IT AND REPLACED IT WITH THE ABSORBABLE SUTURE. THE PACKAGING ON THE NON-ABSORBABLE SUTURE HAD A GREEN COLORED STRIP AT THE TOP, BUT THE WORDS BELOW DESCRIBED IT AS BLUE, WHILE THE ABSORBABLE SUTURE HAD NO COLORED STRIP BUT STATED GREEN ON THE FRONT OF THE PACKAGE. BOTH SUTURES WERE STORED NEXT TO ONE ANOTHER AND LABELED ON THE SHELF CORRECTLY, AND ERROR OCCURRED WITH THIS ''LOOK ALIKE, SOUND ALIKE" PRODUCT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15814279 ↗
• MalfunctionNov 2, 2022Device Markings/Labelling Problem

  PATIENT UNDERGOING SURGICAL PROCEDURE AND REQUIRED ABSORBABLE SUTURE. WHEN THE OR STAFF PULLED THE SUTURE ASKED FOR BY THE PROVIDER, SHE PULL THE NON-ABSORBABLE VERSION OF THE SAME BRAND. THE PROVIDER USED THE INCORRECT SUTURE ON THE PATIENT REQUIRING A RETURN TO SURGERY TO REMOVE IT AND REPLACE IT WITH THE ABSORBABLE SUTURE. THE PACKAGING ON THE NON-ABSORBABLE SUTURE HAS A GREEN COLORED STRIP AT THE TOP BUT THE WORDS BELOW DESCRIBE IT AS BLUE. THE ABSORBABLE SUTURE HAS NO COLORED STRIP BUT STATES GREEN ON THE FRONT OF THE PACKAGE. BOTH SUTURES ARE STORED NEXT TO ONE ANOTHER AND LABELED ON THE SHELF CORRECTLY. APPEARS HUMAN ERROR OCCURRED WITH THIS 'LOOK ALIKE, SOUND ALIKE" PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 15713767 ↗
• InjuryNov 23, 2021Labelling, Instructions for Use or Training Problem; Adverse Event Without Identified Device or Use Problem; Labelling, Instructions for Use or Training Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC HYSTERECTOMY, THE VAGINAL CUFF WAS INADVERTENTLY CLOSED WITH THE NON-ABSORBABLE SUTURE. THE PATIENT HAD TO HAVE THE SUTURE REMOVED DUE TO THIS. THE SURGEON STATED THAT THE PRODUCT REFERENCE NUMBERS WERE TOO SIMILAR AND INCREASED LIKELIHOOD OF MISTAKING ABSORBABLE FOR NON-ABSORBABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12865906 ↗