Z-2370-2020Class II

Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 g/cm, Nominal...

Name: Z-2370-2020 Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 g/cm, Nominal...
Creator: Abbott Vascular
Published: 2020-03-25
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2020-03-25 / Terminated

FDA source

Abbott Vascular began a recall of Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 g/cm, Nominal Everolimus Content: 209 g; Lot number 903224A on 2020-03-25. FDA classified it as Class II and gives the reason as "Incorrect expiration date". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2370-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-25
Posted: 2020-06-15
Terminated: 2021-07-12
Recalling firm: Abbott Vascular
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,
Product code: NIQ Coronary Drug-Eluting Stent
Reason for recall: Incorrect expiration date
FDA root cause: Incorrect or no expiration date
Action: On March 25, 2020, the firm informed their customers that the firm has become aware that products were labeled with the incorrect expiration date. The firm sent an "Urgent Medical Device Recall" to customers. The recalled devices were shipped with a 36 months labeled expiration date, instead of 12 month expiration date. The firm is instructing customers to : - Review their inventory and immediately stop using devices from this lot - Complete and return the attached Effectiveness Check Form - Return all unused affected product to the firm. - Share this notification with other relevant personnel in their organization The firm requested customers to report any adverse reactions or quality problems to Customer Service Department at (800) 227-9902 and to return the "Effectiveness Check Form" to Customer Service Department at (800) 227-9902, scanned copy via E-mail to [email protected]; return a copy of this form with the returned product.
Quantity in commerce: 13 units
Distribution: US Nationwide distribution including in the states of NJ, HI, MD, FL, NV, CA, KS and PR. No foreign consignee
Product codes and lots: Lot Number: 903224A; Device Identifier/GTIN 08717648227455

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2370-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2370-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-15

Product code NIQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)