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SpiderFX™ SPD2-US-060-190Recalls & reported problems

Ev3, Inc · EP SPD2-US-060-190 SPIDER FX V04 · Class 2

All models of SpiderFX (8)

Data updated Oct 16, 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 00821684068359), received between Aug 24, 2020 and Aug 24, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    PHYSICIAN INTENDED TO USE A SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF THE PATIENT¿S PROXIMAL COMMON CAROTID ARTERY. IFU WAS FOLLOWED. IT IS REPORTED THE SPIDER FILTER DETACHED AND REMAINED IN THE PETROUS SEGMENT OF THE CAROTID. POST-DILATION WAS PERFORMED TO PUSH THE FILTER UP AGAINST THE ARTERY AND PLACED TO STENT TO CAGE THE FILTER AS IT COULD NOT BE REMOVED FROM THE PATIENT. NO INJURY REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10442211 ↗

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page