# FDA recall Z-0509-2024

> **Spectranetics Corporation** · Class II · device recall initiated 2023-11-15.

## Product

Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159    Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006    Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159    Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.7 OTW REF 417-152    The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of  infrainguinal stenoses and occlusions in humans.

## Reason for recall

Incorrect product labeling.  Exterior product box label does not match internal pouch label.

## Distribution

U.S Nationwide - Worldwide Distribution:  US Distribution: AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, and WA  Foreign Distribution: Germany, Italy, Poland and Spain

## Key facts

- **Recall number:** Z-0509-2024
- **Recalling firm:** Spectranetics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-15
- **Report date:** 2023-12-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Colorado Springs, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0509-2024

## Citation

> AI Analytics. FDA recall Z-0509-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0509-2024. Source: US FDA. Licensed CC0.

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