Drug recall
Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF…
FDA recall event 88951 · Class II · Medtronic Vascular, Inc.
Key facts
| Event ID | 88951 |
|---|---|
| Recall numbers | Z-0290-2022, Z-0291-2022, Z-0292-2022 |
| Recalling firm | Medtronic Vascular, Inc. |
| Product type | Devices |
| Products | Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT…, Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE…, Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube., During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube |
| Initiation date | Oct 15, 2021 |
| Report date | Dec 1, 2021 |
| City | Santa Rosa |
| State | CA |
| Country | United States |
| FEI number | 3005364322 |
At a glance
- 1–9 Products in this recall
- 1–9 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: