FDA-Device2019-06-26Class I

Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35257 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary v

Cook Inc.

Hazard

Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and balloon fragmentation in the patient.

Sold states

Worldwide Distribution - US Nationwide The affected product was distributed to the following states: FL, OH, WA. The products were distributed to the following foreign countries: Belgium, Denmark, Finland, Germany, Italy, Netherlands, Norway, Poland, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

Affected count

Manufactured in

750 N Daniels Way, N/A, Bloomington, IN, United States

Products

Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35257 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary vasculature.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1758-2019

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