Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Pacific Xtreme (PTCA Balloon Dilation Catheter) Recalled by ev3 Inc. Due to Labeling discrepancy for the Rated Burst Pressure (RBP)...
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 ev3 Inc. directly.
Affected Products
Pacific Xtreme (PTCA Balloon Dilation Catheter)
Quantity: 4286 devices
Why Was This Recalled?
Labeling discrepancy for the Rated Burst Pressure (RBP) value.
Where Was This Sold?
This product was distributed to 41 states: AL, AZ, AR, CA, CO, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV, WI, DC
About ev3 Inc.
ev3 Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report