Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid… — Class II medical device recall Z-2863-2017
Terminated recall by Spectranetics Corporation, reported 2017-08-09, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Cat
| Recall number | Z-2863-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectranetics Corporation, Colorado Springs, CO, United States |
| Recall initiated | 2017-06-06 |
| Classified | 2017-08-02 |
| Reported by FDA | 2017-08-09 |
| Terminated | 2021-07-08 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | BH, BR, CA, IT, JP, NL |
| Reason classes | labeling |
| Model numbers | 414-159, 417-156, 420-159 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2863-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.