V-Loc 180 VLOCL0024Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10884521130418), received between Oct 16, 2017 and Sep 2, 2022 — classified as 6 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (15 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 24, 2026Class IIOpen, Classified

   Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

   Z-2919-2026 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC SURGERY FOR ARTIFICIAL HEAD SURGERY, WHILE SUTURING THE SUBCUTANEOUS DERMIS SUTURE, THE NEEDLE BROKE. AN X-RAY WAS PERFORMED FOR LOCATING THE NEEDLE OR CONFIRMING THAT ALL PIECES WERE LOCATED; THE BROKEN PIECE OF NEEDLE WAS REMOVED. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE IS NO PROBLEM WITH THE PATIENT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15352794 ↗
• InjuryApr 18, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THE WOUND OPENED ON TWO WEEKS FOLLOW-UP WITH SUTURE STILL INTACT. DEBRIDEMENT DONE, AND TISSUE WAS SENT TO PATHOLOGIST. AN EXTREME INFLAMMATORY RESPONSE WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14137833 ↗
• MalfunctionJan 15, 2021Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DISENGAGED. THERE WAS NO PROBLEM AFTER DEALING WITH ANOTHER SAME PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11177789 ↗
• MalfunctionOct 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE CAME OFF BEFORE USING THIS PRODUCT ON PATIENT. IT WAS NOTED THAT THERE WAS NO PARTICULAR TENSION APPLIED OR COMPLICATED HANDLING PERFORMED. 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 10676926 ↗
• MalfunctionDec 30, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A TOTAL HIP ARTHROPLASTY PROCEDURE, THE NEEDLE BREAKAGE OCCURRED AT DERMIS SUTURING. IT WAS REPORTED THAT THERE WERE STILL 2 STITCHES OF BACKBITE NEEDED UNTIL THE INCISION CLOSURE, WHEN THE NEEDLE WAS INSERTED TO THE TISSUE, THE NEEDLE BROKE AT THE SWAGE WITH A CRISPY SOUND. THE NEEDLE REMAINED IN THE TISSUE, THE SURGEON THEN CUT THE SUTURING SITE WITH SCISSORS AND OPENED THE INCISION CLOSURE PART TO RETRIEVE THE NEEDLE. THE SURGEON THEN REPAIRED THE INCISION SITE USING A NEW SUTURE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9530353 ↗
• InjuryOct 22, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING BREAST SURGERY, TWO NEEDLES BROKE. ANOTHER STRAND WAS USED TO COMPLETE THE CASE. AN X-RAY WAS PERFORMED TO FIND A MISSING NEEDLE POINT OF ONE NEEDLE BUT NOTHING WAS LOCATED.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9221909 ↗
• InjuryOct 22, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING BREAST SURGERY, TWO NEEDLES BROKE. ANOTHER STRAND WAS USED TO COMPLETE THE CASE. AN X-RAY WAS PERFORMED TO FIND A MISSING NEEDLE POINT OF ONE NEEDLE BUT NOTHING WAS LOCATED.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9221898 ↗
• MalfunctionNov 26, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING AN ARTIFICIAL KNEE JOINT PLACEMENT, WHILE THE PRODUCT WAS USED IN THE DERMIS SUBCUTANEOUS SUTURE, AT THE 10TH SUTURING, THE THREAD BROKE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8104721 ↗
• MalfunctionSep 21, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7898131 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER UTILIZING THE SUTURE FOR REPAIR OF CRICOTRACHEAL STENOSIS FOLLOWING A LARYNGOSTERNOPEXY SURGICAL PROCEDURE, THERE WERE ADVERSE EVENTS EXPERIENCED. THESE INCLUDED ACUTE AIRWAY OBSTRUCTION REQUIRING EMERGENCY TRACHEOSTOMY THROUGH THE ANASTOMOSIS, A TRACHEAL DEHISCENCE, LARYNGEAL EDEMA WITH AIRWAY OBSTRUCTION, SUPERFICIAL WOUND INFECTIONS, NECK ABSCESSES, AND TRANSIENT VOCAL CORD IMMOBILITY. IT WAS ALSO REPORTED THAT THE SUTURES WERE TIED TOGETHER AT THE MIDLINE OF THE ANTERIOR PORTION OF THE ANASTOMOSIS.

  Patient problems: Abscess; Airway Obstruction; Edema; No Code Available; Organ Dehiscence; Unspecified Infection

  MAUDE report 7846610 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER UTILIZING THE SUTURE FOR REPAIR OF CRICOTRACHEAL STENOSIS FOLLOWING A LARYNGOSTERNOPEXY SURGICAL PROCEDURE, THERE WERE ADVERSE EVENTS EXPERIENCED. THESE INCLUDED ACUTE AIRWAY OBSTRUCTION REQUIRING EMERGENCY TRACHEOSTOMY THROUGH THE ANASTOMOSIS, A TRACHEAL DEHISCENCE, LARYNGEAL EDEMA WITH AIRWAY OBSTRUCTION, SUPERFICIAL WOUND INFECTIONS, NECK ABSCESSES, AND TRANSIENT VOCAL CORD IMMOBILITY. IT WAS ALSO REPORTED THAT THE SUTURES WERE TIED TOGETHER AT THE MIDLINE OF THE ANTERIOR PORTION OF THE ANASTOMOSIS.

  Patient problems: Abscess; Airway Obstruction; Edema; No Code Available; Organ Dehiscence; Unspecified Infection

  MAUDE report 7846316 ↗
• MalfunctionJul 20, 2018Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE DETACHED. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7706217 ↗
• MalfunctionJul 11, 2018Break; Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA OPERATIVELY, THE NEEDLE BROKE AT THE SWAGE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7677471 ↗
• MalfunctionJul 3, 2018Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, SOME PRODUCTS HAD BEEN TIED WHEN OPENING AND SOME BROKE THE LOOP. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7659014 ↗
• MalfunctionJul 3, 2018Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, SOME PRODUCTS HAD BEEN TIED WHEN OPENING AND SOME BROKE THE LOOP. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7658983 ↗
• MalfunctionApr 25, 2018Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN ORTHOPEDIC PROCEDURE, WHEN THE SURGEON WAS PERFORMING A REGULAR SUTURE THE THREE DEVICES HAD AN UNKNOWN ISSUE. THE PATIENT'S OUTCOME WAS ASKED AND WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7458422 ↗
• MalfunctionJan 31, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE LOOP WAS BROKEN, AND THE SAME EVENT OCCURRED REPEATEDLY DURING THE SAME SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7232461 ↗
• MalfunctionJan 31, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE LOOP WAS BROKEN, AND THE SAME EVENT OCCURRED REPEATEDLY DURING THE SAME SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7231468 ↗
• MalfunctionJan 30, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING TOTAL KNEE ARTHROPLASTY, DURING SUTURING, THE LOOP BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7229060 ↗
• MalfunctionDec 20, 2017Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY DURING ARTIFICIAL JOINT REPLACEMENT SURGERY, 3 SUTURES BROKE CONSECUTIVELY. THE PROCEDURE WAS COMPLETED USING ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7134567 ↗
• MalfunctionDec 6, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE'S THREAD WAS BROKEN AT THE LOOP. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE PATIENT HAD NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7089103 ↗
• MalfunctionNov 10, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE LOOP BROKE WHILE SUTURING. NOTHING FELL INTO THE PATIENT CAVITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT STATUS IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7017850 ↗
• MalfunctionOct 16, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THE SUTURE THREAD BROKE. NOTHING FELL INTO THE PATIENT CAVITY. OOZING OR BLEEDING WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE DEVICE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6952719 ↗