Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Recall Insight

This FDA Devices action (record #Z-0390-2019) was formally reported on November 14, 2018, with the manufacturer initiating the action on September 5, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Cordis Corporation is listed as the recalling firm, operating out of Miami Lakes, FL. Federal records list the affected scope as 162 units total (74 units in USA).

The documented reason for this recall is: Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test). Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide in the states of AL, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MO, MS, NC, ND, NJ, OH, PA, SC, TN, TX, and WI. Countries of Japan and Netherlands.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.