V-Loc 180 VLOCL0813Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884521131293), received between Aug 3, 2017 and May 4, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Break” (18 reports).

1 other recall cover devices cleared under the same FDA submission (K091087); 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Break

  ACCORDING TO THE REPORTER, DURING A PACEMAKER POCKET POSITION, WHILE SUTURING, THREE SUTURES BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073207 ↗
• MalfunctionMay 4, 2026Break

  ACCORDING TO THE REPORTER, DURING A PACEMAKER POCKET POSITION, WHILE SUTURING, THREE SUTURES BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073055 ↗
• MalfunctionMay 4, 2026Break

  ACCORDING TO THE REPORTER, DURING A PACEMAKER POCKET POSITION, WHILE SUTURING, THREE SUTURES BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072918 ↗
• MalfunctionDec 18, 2025Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING, THE THREAD BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23844048 ↗
• MalfunctionOct 14, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A RIGHT INGUINAL REDUCIBLE MASS PROCEDURE, WHEN ABSORBABLE SUTURE WAS ABOUT TO BE USED FOR PERITONEAL CLOSURE, THE NEEDLE HOLDER WAS USED FOR SUTURING AND THE NEEDLE BROKE AT THE SHANK. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23276003 ↗
• MalfunctionJun 18, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC DISTAL GASTRECTOMY, WHEN ON JEJUNOJEJUNOSTOMY, THE THREAD BROKE FOR THE TWO SUTURES WHILE USING CONTINUOUS SUTURING. TO RESOLVE THE ISSUE, THE SURGEON SWITCHED TO BARBED SUTURES FROM ANOTHER MANUFACTURER FOR SUTURING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288600 ↗
• MalfunctionApr 30, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE ABSORBABLE SUTURE WAS USED NORMALLY IN THE EARLY STAGE OF SUTURING DURING THE OPERATION, BUT THE SUTURE WAS BROKEN LATER. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 21933568 ↗
• MalfunctionApr 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN KNEE REPLACEMENT PROCEDURE, THE SUTURE THREAD BROKE WHILE SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918322 ↗
• MalfunctionJan 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL THYROIDECTOMY PROCEDURE, WHILE SUTURING THE WHITE LINE OF THE NECK, THE NEEDLE AND THREAD DETACHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208705 ↗
• MalfunctionMar 13, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROCEDURE, THE STRANDS WERE SNAPPING.

  Patient problems: Insufficient Information

  MAUDE report 18899780 ↗
• MalfunctionJan 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN GASTROINTESTINAL ANASTOMOSIS WAS PERFORMED, BOTH NEEDLE AND THREAD HAD BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16268961 ↗
• MalfunctionJan 10, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ASSISTED GASTRIC TUMOR RESECTION PROCEDURE, WHEN SUTURING AT THE GASTRIC TISSUE, THE SUTURE BROKE MANY TIMES AND BROKE WITH A LITTLE FORCE. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132993 ↗
• MalfunctionOct 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE UNUSED NEEDLE FELL OUT WHEN THE PACKAGE WAS OPENED. NORMALLY, THE NEEDLE SHOULD BE FIRM AND NOT TO FELL OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15590107 ↗
• MalfunctionJul 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHEN THE PACKAGE WAS OPENED AND IT WAS NOT YET IMPLANTED IN THE HUMAN BODY, IT WAS FOUND THAT BOTH NEEDLE AND THREAD WERE BROKEN. THE DEVICE WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14960902 ↗
• MalfunctionNov 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC RIGHT INGUINAL HERNIA REPAIR, WHEN THE SURGEON STARTED SUTURING OF THE PERITONEUM USING CONTINUOUS SUTURE TECHNIQUE, IT WAS FOUND THAT THE BARB THREAD WAS SEPARATED FROM THE SUTURE NEEDLE. THE NEEDLE AND REMAINING SUTURES WERE TAKEN OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12754536 ↗
• MalfunctionSep 7, 2021Break; Break

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, ON A GYNECOLOGICAL OVARIECTOMY SURGERY, 5 MINUTES AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THE 6 NEEDLES WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12434518 ↗
• MalfunctionApr 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, IN ORDER TO USE IN PACEMAKER IMPLANTATION, THE NEEDLE WAS HELD WITH NEEDLE HOLDER TO TAKE THE THREAD OUT OF THE PACKET, AT THAT TIME, THE NEEDLE AND THREAD CAME APART, MAKING IT IMPOSSIBLE TO USE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648507 ↗
• MalfunctionFeb 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AFTER TAKING THE PACKAGE OUT PRE-OPERATIVELY, THE SUTURE HAD THE NEEDLE AND THREAD BROKE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307693 ↗
• MalfunctionFeb 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AFTER TAKING THE PACKAGE OUT PRIOR A GYNECOLOGICAL PROCEDURES, THREE SUTURES HAD BOTH NEEDLE AND THREAD B ROKEN WHILE ANOTHER SUTURE HAD BROKEN THREAD. AN ADDITIONAL NEW SUTURE USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11278710 ↗
• MalfunctionSep 16, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE THREAD BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10543907 ↗
• MalfunctionSep 15, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD OF THE DEVICE GOT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10537434 ↗
• MalfunctionMar 27, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, AT THE START TIME OF THE SUTURE USING THE DERMIS SUBCUTANEOUS SUTURE TECHNIQUE, THE LOOP OF THE THREAD EASILY DISENGAGED. THE THREAD ALSO BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8455691 ↗
• MalfunctionMay 21, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING A SUTURING, THE NEEDLE DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7529945 ↗
• MalfunctionApr 19, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY FOR PROSTATE CANCER, WHILE SUTURING, THE THREAD BROKE IN THE MIDDLE WAY. COMPARED TO THE PRODUCTS USED BEFORE, IT WAS NOTED THAT THE THREAD EASILY BREAKS. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7443178 ↗
• MalfunctionOct 31, 2017Break; Break

  ACCORDING TO THE REPORTER, THE LOOP OF THE SUTURE BROKE. THIS HAPPENED TWICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6990072 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091087. One submission often covers many models, so check the product and lot details in each record.

• Z-2919-2026 · Jun 24, 2026 · Open, Classified
  V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX0