Pacific Xtreme (PTCA Balloon Dilation Catheter)
Reported: October 7, 2020 Initiated: August 26, 2020 #Z-3055-2020
Product Description
Pacific Xtreme (PTCA Balloon Dilation Catheter)
Reason for Recall
Labeling discrepancy for the Rated Burst Pressure (RBP) value.
Details
- Recalling Firm
- ev3 Inc.
- Units Affected
- 4286 devices
- 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.
- Location
- Plymouth, MN
Frequently Asked Questions
What product was recalled? ▼
Pacific Xtreme (PTCA Balloon Dilation Catheter). Recalled by ev3 Inc.. Units affected: 4286 devices.
Why was this product recalled? ▼
Labeling discrepancy for the Rated Burst Pressure (RBP) value.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 7, 2020. Severity: Moderate. Recall number: Z-3055-2020.
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