Indications, Safety, & Warnings Fortrex™ HP PTA balloon catheter

Note: Safety information provided is for the United States. Please refer to your region’s Instructions for Use for specific details.

This therapy is not for everyone. Please consult your physician. A prescription is required. For more information, please call Medtronic at 763-514-4000 (worldwide). Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions.

Reference statement

Indications for Use

The Fortrex HP PTA balloon catheter is indicated for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in native or synthetic arteriovenous dialysis fistulae.


The Fortrex HP PTA balloon catheter is contraindicated for use in coronary arteries or the neurovasculature, or when unable to cross the target lesion with a guidewire.

Potential Adverse Events

The potential adverse events (or complications) that may occur or require intervention with the use of this device include, but are not limited to, the following conditions: Abrupt or subacute closure; Allergic reaction to device materials or procedure medications; Amputation; Aneurysm; Arrhythmia; Bleeding requiring transfusion; Contrast medium reaction or renal failure; Death; Embolism; Endocarditis; Fever; Hematoma; Hemorrhage; Hypertension or hypotension; Iatrogenic arteriovenous fistula; Infection; Inflammation; Intraluminal thrombus; Myocardial infarction; Pseudoaneurysm; Regional ischemia; Sepsis; Shock; Stenosis or restenosis; Stroke; Transient ischemic attack; Venous thromboembolism; Vessel injury (such as dissection, perforation, or rupture); Vessel spasm. If a serious incident related to the device occurs, immediately report the incident to Medtronic and the applicable competent authority or regulatory body.


Please reference the Instructions for Use (IFU) or Electronic Instructions for Use (eIFU) at for a complete listing of indications, contraindications, warnings and precautions, adverse effects, and suggested procedure.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.