Sniper® SBC0629-KTP-150Recalls & reported problems
Embolx, Inc. · The Sniper is a dual lumen, 150cm, angled 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00853359008087), received between Aug 27, 2019 and Jun 19, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem1
- Unsealed Device Packaging1
Patient problems
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2020Deflation Problem; Deflation Problem
BALLOON WOULD NOT DEFLATE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10176840 ↗MalfunctionAug 27, 2019Unsealed Device Packaging; Unsealed Device Packaging
PRIMARY POUCH PACKAGING OF THE DEVICE WAS NOT SEALED. DEVICE WAS NOT USED ON A PATIENT. DEVICE WAS PACKAGED (ONE POUCH PER SHELF BOX), LABELED, AND STERILIZED WITH POUCH END OPEN, UNSEALED. OPERATOR AND EMBOLX REPRESENTATIVE NOTED COMPROMISE TO PACKAGING AND RETURNED THE DEVICE UNUSED TO EMBOLX.
Patient problems: No Patient Involvement
MAUDE report 8938093 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.