Drug recall
Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that…
FDA recall event 80513 · Class II · Boston Scientific Corporation
Key facts
| Event ID | 80513 |
|---|---|
| Recall numbers | Z-2735-2018 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential polymer material degradation. |
| Initiation date | Dec 11, 2017 |
| Report date | Aug 15, 2018 |
| Termination date | Nov 4, 2019 |
| City | Maple Grove |
| State | MN |
| Country | United States |
| FEI number | 3002095335 |
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: