Drug recall
Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531…
FDA recall event 95815 · Class II · Spectranetics Corporation
Key facts
| Event ID | 95815 |
|---|---|
| Recall numbers | Z-0680-2025 |
| Recalling firm | Spectranetics Corporation |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted. |
| Initiation date | Nov 25, 2024 |
| Report date | Dec 25, 2024 |
| City | Colorado Springs |
| State | CO |
| Country | United States |
| FEI number | 3007284006 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: