SpiderFX™ SPD2-US-030-190Recalls & reported problems
Ev3, Inc · EP SPD2-US-030-190 SPIDER FX V04 · Class 2
All models of SpiderFX (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684068298), received between Jul 18, 2019 and Jun 26, 2020 — classified as 1 injury, 1 malfunction.
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
- Mechanical Problem1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE PHYSICIAN ATTEMPTED TO USE A SPIDER FX TO TREAT THE LEFT DISTAL VEIN GRAFT TO DIAGONAL. TYPE OF TARGET LESION, DEGREE OF TORTUOSITY, DEGREE OF CALCIFICATION AND % LESION STENOSIS ARE UNKNOWN. IT IS UNKNOWN IF THE VESSEL WAS PRE-DILATED OR POST DILATED, OR IF THE IFU WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. IT WAS REPORTED THAT THE FILTER WIRE BASKET BROKE OFF AND REMAINED IN THE PATIENT. THE DEVICE WAS UNABLE TO BE SNARED AND/OR RETRIEVED TO BE REMOVED FROM BODY AND A STENT WAS PLACED TO PIN FILTER BASKET AGAINST VESSEL WALL AND MAINTAIN LUMINAL INTEGRITY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10199354 ↗MalfunctionJul 18, 2019Mechanical Problem; Mechanical Problem
THE PHYSICIAN WAS INTENDING TO USE A SPIDERFX FOR TREATMENT. IT WAS REPORTED THAT THE PHYSICIAN PROLAPSED THE DEVICE AND BENT THE WIRE TIP DISTAL TO THE SPIDER BASKET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE EVENT REPORTED FOR THE PATIENT. WHEN THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY, IT WAS NOTED THAT THE DEVICE WAS DAMAGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8801635 ↗
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- ANGIOGUARD 501814RMCCordis Corporation · Temporary Carotid Catheter For Embolic Capture1 recall14 reports
- ANGIOGUARD 601814RMCCordis Corporation · Temporary Carotid Catheter For Embolic Capture1 recall11 reports
- SpiderFX™ SPD2-US-060-320Ev3, Inc · Temporary Carotid Catheter for Embolic Capture1 death57 reports
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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