FDA Device recall Z-2370-2020
Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus Content: 209 ¿g
- FDA Device
- Class II
- terminated
- Published 2020-06-24
On 2020-06-24 the FDA classified a Class II recall of Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus Content: 209 ¿g by Abbott Vascular, citing incorrect expiration date.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2370-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-25 |
| Published | 2020-06-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Vascular |
| Distribution | US |
Product
Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus Content: 209 ¿g; Lot number 903224A,
Reason
Incorrect expiration date
Identifiers
| code_info | Lot Number: 903224A; Device Identifier/GTIN 08717648227455 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2370-2020%22
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