# FDA recall Z-2863-2017

> **Spectranetics Corporation** · Class II · device recall initiated 2017-06-06.

## Product

Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters   Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions

## Reason for recall

Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when the device is in use in an off-label manner.

## Distribution

Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, Hawaii and Puerto Rico  Foreign distribution to Bahrain, Brazil, Canada, Italy, Japan, and Netherlands

## Key facts

- **Recall number:** Z-2863-2017
- **Recalling firm:** Spectranetics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-06
- **Report date:** 2017-08-09
- **Termination date:** 2021-07-08

- **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-2863-2017

## Citation

> AI Analytics. FDA recall Z-2863-2017. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-2863-2017. Source: US FDA. Licensed CC0.

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