Abbott Vascular Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 g/cm, Nominal Everolimus Content: 209 g; Lot number 903224A, Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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,
Brand
Abbott Vascular
Lot Codes / Batch Numbers
Lot Number: 903224A, Device Identifier/GTIN 08717648227455
Products Sold
Lot Number: 903224A; Device Identifier/GTIN 08717648227455
Abbott Vascular is recalling Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 g/cm, Nomina due to Incorrect expiration date. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect expiration date
Recommended Action
Per FDA guidance
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 AVRegulatoryCompliance@av.abbott.com; return a copy of this form with the returned product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026