# FDA recall Z-0680-2025

> **Spectranetics Corporation** · Class II · device recall initiated 2024-11-25.

## Product

Turbo Elite Laser Atherectomy Catheter  Model Number / UDI-DI code / Product Description  414-151 / 989930000531 / 1.4 mm OTW  417-152 / 989930000551 / 1.7 mm OTW  420-006 / 989930000571 / 2.0 mm OTW  423-001 / 989930000591 / 2.3 mm OTW  425-011 / 989930000601 / 2.5 mm OTW  423-135-01 / 989930004171 / 2.3 mm OTW  423-135-02 / 989930004181 / 2.3 mm OTW  425-135-01 / 989930004201 / 2.5 mm OTW  425-135-02 / 989930004211 / 2.5 mm OTW    The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.

## Reason for recall

Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.

## Distribution

U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, ILIN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD TN, TX, UT, VA, WA, WI, and WV.  O.U.S.: Australia, Belgium, Brazil, China, Croatia, Cyprus, Czech Republic, Denmark, France, Germany, Italy, Japan, Kuwait, Netherlands, Poland, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-0680-2025
- **Recalling firm:** Spectranetics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-25
- **Report date:** 2024-12-25

- **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-0680-2025

## Citation

> AI Analytics. FDA recall Z-0680-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0680-2025. Source: US FDA. Licensed CC0.

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