Aperta NSE™ PTA Balloon Dilatation Catheter
GOODMAN CO.,LTD. · Model AW18-09060040 · UDI-DI 04543660025762
Description
The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 90cm, Diameter = 6.0mm, Length = 40mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-05-24 | Cook Inc. | 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 t |
| 2019-05-24 | Cook Inc. | 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 t |
| 2019-05-24 | Cook Inc. | 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 t |
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