A Class I recall of Cook's Advance Enforcer 35 Focal-Force Percutaneous PTA Balloon Catheter 6 mm x 4 cm, designed for percutaneous transluminal angioplasty of peripheral artery lesions, has been announced by the FDA. The recall was initiated due to multiple reports of balloons bursting below the rated burst pressure.
FDA announces Class I recall of Cook's PTA balloon catheter
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