News | January 03, 2011

Peripheral Balloon Catheters Recalled Due to Shaft Cracks

January 3, 2011 – ev3, a Covidien company, has initiated a voluntary recall of specific lots of the NanoCross .014-inch Over-the-wire (OTW) peripheral transcatheter angioplasty (PTA) dilatation catheter due to the potential for the catheter shaft to crack or break during use. Cracking or breaking of the catheter shaft may result in the inability to inflate or deflate the balloon, and may result in material separation and potential embolization.

The NanoCross 0.014” OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries. It is also used for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The company said catheter failure may lead to unplanned intravascular or open surgery, significant vasospasm, prolonged tissue ischemia, injury, infarct, bleeding and/or death.

In a letter dated Nov. 10, 2010, ev3 notified healthcare facilities of the NanoCross .014 OTW PTA dilatation catheters voluntary recall. In this letter, it was requested that all affected products are located and removed from use. Detailed steps were also provided about the return and disposition of these affected products to ev3.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Questions should be directed to ev3 at 763.398.7000.

For more information: www.fda.gov/Safety/Recalls/ucm238306.htm

Related Content

News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
Ra Medical Systems Granted Broad Patent for DABRA Catheter
News | Peripheral Artery Disease (PAD)| August 09, 2017
August 9, 2017 — Ra Medical Systems announced that the United States Patent and Trademark Office (USPTO) has granted
The LimFlow Percutaneous Deep Vein Arterialization System (pDVA) converts veins into arteries to restore blood flow in critical limb ischemia (CLI).

The LimFlow Percutaneous Deep Vein Arterialization System (pDVA) converts veins into arteries to restore blood flow in critical limb ischemia (CLI). This image shows how the covered stents used with the system connect to create a new arterial pathway.

News | Peripheral Artery Disease (PAD)| August 02, 2017
Aug.
Spectranetics Announces FDA Approval of Stellarex Drug-Coated Balloon
Technology | Drug-Eluting Balloons| July 26, 2017
The Spectranetics Corp. announced receipt of U.S. Food and Drug Administration (FDA) pre-market approval (PMA) of the...
First European Patient Enrolled in Intact Vascular's TOBA II BTK Trial
News | Stents Peripheral| July 26, 2017
Intact Vascular Inc. recently announced that its Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK)...
Sponsored Content | Videos | Peripheral Artery Disease (PAD)| July 25, 2017
This video case study, provided by Gore Medical, is titled "Tackling Complex Cases in Dialysis Access," by John Ross,
First Patient Treated in U.S. Feasibility Study of LimFlow Critical Limb Ischemia Device
News | Peripheral Artery Disease (PAD)| July 17, 2017
LimFlow SA announced enrollment of the first patient in the U.S. feasibility study of the LimFlow Percutaneous Deep...
FDA Approves Six-Month Primary Endpoint for Tack Endovascular System in Below the Knee Disease
News | Stents Peripheral| July 14, 2017
Intact Vascular Inc. announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption...
Philips Announces Relaunch of Pioneer Plus IVUS-Guided Catheter
News | Chronic Total Occlusion (CTO)| June 28, 2017
June 28, 2017 — Royal Philips recently announced the relaunch of its Pioneer Plus...
Shockwave Medical Announces U.S. Commercial Availability of Lithoplasty System
News | Peripheral Artery Disease (PAD)| June 26, 2017
Shockwave Medical recently announced two milestones for its Lithoplasty System for the treatment of calcified plaque in...
Overlay Init