# FDA recall Z-3055-2020

> **ev3 Inc.** · Class II · device recall initiated 2020-08-26.

## Product

Pacific Xtreme (PTCA Balloon Dilation Catheter)

## Reason for recall

Labeling discrepancy for the Rated Burst Pressure (RBP) value.

## 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.

## Key facts

- **Recall number:** Z-3055-2020
- **Recalling firm:** ev3 Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-26
- **Report date:** 2020-10-07
- **Termination date:** 2023-06-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plymouth, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3055-2020

## Citation

> AI Analytics. FDA recall Z-3055-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-3055-2020. Source: US FDA. Licensed CC0.

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