Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code /… — Class II medical device recall Z-0680-2025
Ongoing recall by Spectranetics Corporation, reported 2024-12-25, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in
| Recall number | Z-0680-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectranetics Corporation, Colorado Springs, CO, United States |
| Recall initiated | 2024-11-25 |
| Classified | 2024-12-16 |
| Reported by FDA | 2024-12-25 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, 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, WV |
| Countries outside the US | AE, AU, BE, BR, CH, CN, CY, CZ, DE, DK, ES, FR, GB, HR, IT, JP, KW, NL, PL, SE |
| Quantity | 40,276 catheters |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00813132024710, 00813132024734, 00813132024758, 00813132024772, 00813132024789, 00813132024796, 00813132024802, 00813132024819 |
| Model numbers | 12NC |
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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.
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-0680-2025. 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.