ev3 Inc. Recall: Pacific Xtreme (PTCA Balloon Dilation Catheter)
ev3 Inc. Recall: Pacific Xtreme (PTCA Balloon Dilation Catheter) is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: ev3 Inc.; Product: Pacific Xtreme (PTCA Balloon Dilation Catheter); Reason for recall: Labeling discrepancy for the Rated Burst Pressure (RBP) value..
| Recalling firm | ev3 Inc. |
|---|---|
| Product | Pacific Xtreme (PTCA Balloon Dilation Catheter) |
| Reason for recall | Labeling discrepancy for the Rated Burst Pressure (RBP) value. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Domestic Distribution: AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL,IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX,VA, WA, WI and WV. International Distribution: Canada and Puerto Rico. |
| Recall initiated | 20200826 |
| Recall number | Z-3055-2020 |
| Category | device |
| State | MN |
| Country | United States |
$29/mo
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