FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Cardinal Health’s Cordis Broadens Recall of Dilation Catheters

Aug. 29, 2019
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Cardinal Health subsidiary Cordis expanded a recall of its Powerflex Pro percutaneous transluminal angioplasty dilation catheters.

The devicemaker first pulled five Powerflex Pro lots in September 2018 when they failed to meet manufacturing specifications. The malfunction created the risk of a shaft leakage or burst during balloon inflation, but the company noted that there was no safety concern for patients treated successfully using products from the affected lots.

Cordis said it hasn’t received any complaints related to shaft bursts or leakages and noted that the initial five lots have been successfully removed from market.

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