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Sniper SBC0629-STR-110Recalls & reported problems

Embolx, Inc. · The Sniper is a dual lumen, 110cm, straight tip catheter comprised of an inner guidewire/infusion lumen and an outer, annular lumen to inflate and deflate the balloon. The guidewire/infusion port may be used to inject contrast media or therapeutic agents following removal of the guidewire. The catheter has two radiopaque markers: one marker at the distal tip and another in the center of the balloon. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853359008056), received between May 6, 2020 and May 6, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (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.

Most reported problems

Device problems

  • Component Misassembled1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionMay 6, 2020Component Misassembled; Component Misassembled

    BALLOON WOULDN'T DEFLATE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10029256 ↗

Other Catheter, Intravascular Occluding, Temporary devices

All Catheter, Intravascular Occluding, Temporary devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.