Home › Embolx, Inc. › Sniper

Sniper

Embolx, Inc. · Model SBC0629-130 · UDI-DI 00853359008018

MJN Prescription

510(k) clearances

2,348

Adverse events (102 deaths)

Recalls

Facilities

Description

The Sniper is a dual lumen, 130cm, 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.

Recalls

Date	Firm	Reason
2021-07-12	W. L. Gore & Associates Inc.	Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to infl
2020-10-29	Prytime Medical Devices, Inc.	There is a potential that catheters may have incorrectly marked balloon and arterial lines. This could result in a procedure delay or injury to the patient.
2020-03-31	Spectranetics Corporation	There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extraction cases may not
2019-07-24	LeMaitre Vascular, Inc.	incorrect device size being listed on the impacted device packaging
2018-10-01	LeMaitre Vascular, Inc.	Pouches from this lot are not sealed compromising the sterility
2017-08-07	Spectranetics Corporation	Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.
2016-10-31	Spectranetics Corporation	Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to poten
2016-10-06	AccessClosure, Inc., A Cardinal Health Company	AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device because it was made aware from customers that the device may be removed in the absen
2015-11-25	RenovoRx, Inc.	Incorrect version of Instructions for Use were shipped to two US customers.
2013-11-04	Stryker Neurovascular	Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.