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

FDA Device Recall #Z-2370-2020 — Class II — March 25, 2020

Recall Summary

Recall Number Z-2370-2020
Classification Class II — Moderate risk
Date Initiated March 25, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Abbott Vascular
Location Temecula, CA
Product Type Devices
Quantity 13 units

Product Description

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

Distribution Pattern

US Nationwide distribution including in the states of NJ, HI, MD, FL, NV, CA, KS and PR. No foreign consignee

Lot / Code Information

Lot Number: 903224A; Device Identifier/GTIN 08717648227455

Other Recalls from Abbott Vascular

Recall # Classification Product Date
Z-0116-2023 Class II Product/Part: MitraClip NTR Clip Delivery Syste... Sep 8, 2022
Z-0115-2023 Class II Product/Part: MitraClip XTR Clip Delivery Syste... Sep 8, 2022
Z-0117-2023 Class II Product/Part: MitraClip G4 CDS NT REPAIR-MR Cli... Sep 8, 2022
Z-1095-2022 Class I Dragonfly OpStar Imaging Catheter, REF 1014651/... Mar 30, 2022
Z-0924-2022 Class II INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 ... Mar 11, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.