3.3mm Mini-Bolt VUE 21133Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816589021233), received between Dec 13, 2022 and Jul 5, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 5, 2023Material Fragmentation; Material Fragmentation

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT A 3.3MM VUE MINI-BOLT WAS USED. WHEN ANCHORING THE VUE BOLT, THE USER DID A TOTAL OF 5.5 TURNS AFTER START OF PURCHASE. FOR VUE BOLT REMOVAL, THE USER USED THE BLUE HEX ADAPTER. THE BLUE ADAPTER COULD NOT GRIP AND WOULD ONLY SPIN ON TOP OF THE VUE BOLT. INSTEAD, THE USER TRIED TO USE THE VUE BOLT REMOVAL END OF THE REMOVAL TOOL AFTER GIVEN SPECIFIC INSTRUCTIONS TO PREVENT TORQUE TO THE BOLT. THE REMOVAL TOOL WAS TURNED ONCE, THEN AN AUDIBLE NOISE WAS HEARD ON THE SECOND TURN. THE TOOL WAS REMOVED FROM THE BOLT AND THE CERAMIC SHARDS WERE VISIBLE. THE BOLT WAS ANCHORED IN THE LEFT FRONTAL REGION ABOVE THE HAIRLINE. THE VUE BOLT WAS PLACED CLOSE TO PERPENDICULAR TO THE SKULL WITH NO MORE THAN A 10 DEGREE ANGLE. THE USER WAS STANDING ON THE RIGHT SIDE OF THE PATIENT FACING SUPERIORLY REACHING ACROSS TO THE LEFT SIDE FROM ABOVE THE PATIENT WHEN USING THE VUE END OF THE TOOL TO REMOVE THE VUE BOLT. THE CLINICAL SPECIALIST CONFIRMED THAT THE USER FIRST ATTEMPTED TO USE HEMOSTATS AROUND THE VUE BOLT TO REMOVE IT FROM THE SKULL, HOWEVER, IT KEPT SLIPPING. THE USER THEN USED A SMALL DRILL TO MAKE A FEW HOLES AROUND THE BASE OF THE BOLT AROU

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17261817 ↗
• InjuryDec 13, 2022Use of Device Problem; Use of Device Problem

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT THE USER ATTEMPTED TO REMOVE THE CERAMIC MINI-BOLT VUE BOLT USING THE INSERTION DRIVER & BLUE INSERTION DRIVER ADAPTER. THE INTERFACE BETWEEN THE VUE ADAPTER & CERAMIC BOLT BECAME STRIPPED DURING THE PROCESS, SO THE SURGEON ATTEMPTED TO REMOVE THE BOLT USING A SURGICAL CLAMP RATHER THAN USING THE PROVIDED REMOVAL TOOL. WHILE ATTEMPTING TO REMOVE THE BOLT WITH THE SURGICAL CLAMP, THE CERAMIC BOLT BROKE APART WHERE THE CLAMP WAS CONTACTING THE BOLT. THE SURGEON WAS THEN REQUIRED TO DRILL OUT THE BOLT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969011 ↗