June 18, 2019
FDA: Class I recall of Cook Advance Enforcer 35 Focal-Force PTA Balloon Catheter
Editor's Note
The Food & Drug Administration on June 18 identified the recall by Cook Incorporated (Bloomington, Indiana) of its Advance Enforcer 35 Focal-Force PTA Balloon Catheter 6 mm x 4 cm as Class I, the most serious.
The recall was initiated because of multiple complaints of balloons bursting below the rated burst pressure. The catheter is used to open blocked or narrowed arteries that supply blood to the leg.
Distribution dates for the catheters are October 29, 2018, to March 21, 2019.
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