SpiderFX™ SPD2-US-050-190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684068335), received between Jun 11, 2018 and Jun 11, 2018 — 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

Recent adverse event reports

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

• InjuryJun 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS THAT THE PHYSICIAN USED A SPIDER FX DEVICE DURING TREATMENT OF A CTO (CHRONIC TOTAL OCCLUSION-100%) PLAQUE LESION IN THE PATIENT¿S PROXIMAL COMMON CAROTID ARTERY. NO TORTUOSITY AND MODERATE CALCIFICATION WERE REPORTED. THE IFU WAS FOLLOWED DURING THE PROCEDURE. THE DEVICE WAS PREPPED WITHOUT ISSUE. THE VESSEL WAS PRE-DILATED. IT WAS REPORTED THAT THE DELIVERY CATHETER BROKE AND SEGMENTS HAD TO BE RETRIEVED. A SNARE WAS USED TO RETRIEVE THE FRAGMENTS FROM THE PATIENT. THE PROCEDURE WAS THEN COMPLETED WITHOUT THE USE OF EMBOLIC PROTECTION. THE VESSEL WAS POST DILATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7587179 ↗