Data Foundry

Medical device recalls 2020

Xience Sierra TM Everolimus Eluting Coronary Stent System — Class II medical device recall Z-2370-2020

Terminated recall by Abbott Vascular, reported 2020-06-24, distributed nationwide. Incorrect expiration date

Recall numberZ-2370-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAbbott Vascular, Temecula, CA, United States
Recall initiated2020-03-25
Classified2020-06-15
Reported by FDA2020-06-24
Terminated2021-07-12
DistributedNationwide (US)
Quantity13 units
Reason classeslabeling
UPC / GTIN / UDI-DI08717648227455
Lot numbers903224A

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 for recall

Incorrect expiration date

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2370-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.