Mini-Bolt System 21228Recalls & reported problems
Monteris Medical Inc · VUE Extractor Tool · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816589021189), received between Dec 16, 2025 and Dec 16, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Crack” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Crack1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2025Crack; Crack
AT THE END OF AN ABLATION PROCEDURE, IT WAS REPORTED THAT UPON REMOVAL OF THE VUE MINI-BOLT, THE VUE EXTRACTOR TOOL CRACKED AND THE VUE MINI-BOLT COULD NOT BE REMOVED. A SECOND EXTRACTOR TOOL WAS USED WHICH ALSO RESULTED IN A CRACK ALONG THE SIDE OF THE TOOL. A BLUE VUE ADAPTER WAS USED AT THE END OF THE BOLT DRIVER BUT COULD NOT REMOVE THE BOLT AND ONLY SPUN WITHOUT ENGAGING THE BOLT. A THIRD EXTRACTOR TOOL WAS USED FOR ANOTHER ATTEMPT TO REMOVE THE MINI-BOLT, BUT IT JUST SPUN WITHOUT BUDGING THE BOLT. AT THIS POINT, THE SURGEON HAD TO DRILL OUT BONE AROUND THE BOLT IN ORDER TO REMOVE THE BOLT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23817146 ↗
Other Instrument, Surgical, Non-Powered devices
- SenSight™ B31030Medtronic, Inc. · INSTRUMENT, SURGICAL, NON-POWERED1 recall7 reports
- WECK IPN006432Teleflex Incorporated · INSTRUMENT, SURGICAL, NON-POWERED3 reports
- 3.3mm Mini-Bolt VUE 21133Monteris Medical Inc · INSTRUMENT, SURGICAL, NON-POWERED2 reports
- NA 365538Medtronic, Inc. · INSTRUMENT, SURGICAL, NON-POWERED2 reports
- NA 1120Advanced Neuromodulation Systems, Inc. · INSTRUMENT, SURGICAL, NON-POWERED2 reports
- RELIANCE LITe 48060500Stryker Corporation · INSTRUMENT, SURGICAL, NON-POWERED1 report
- NeuroBalloon™ 7CBD10Integra LifeSciences Switzerland Sàrl · INSTRUMENT, SURGICAL, NON-POWERED1 report
- AESCULAP FV002RAesculap AG · INSTRUMENT, SURGICAL, NON-POWERED1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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