Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cordis EMPIRA RX PTCA Dilatation Catheter Recalled by Cordis Corporation Due to The balloon may exhibit resistance to the removal...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cordis Corporation directly.
Affected Products
Cordis EMPIRA RX PTCA Dilatation Catheter
Quantity: 250,000 units.
Why Was This Recalled?
The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.
Where Was This Sold?
This product was distributed to 38 states: AZ, AR, CA, CO, CT, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WY, DC
About Cordis Corporation
Cordis Corporation has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report