Drug recall
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
FDA recall event 90735 · Class II · Boston Scientific Corporation
Key facts
| Event ID | 90735 |
|---|---|
| Recall numbers | Z-1582-2022 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter. |
| Initiation date | Aug 9, 2022 |
| Report date | Aug 31, 2022 |
| 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: