XIENCE Sierra recallZ-2370-2020 · Abbott Vascular · initiated Mar 25, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Vascular or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect expiration date
FDA root cause category: Incorrect or no expiration date
What the company is doing
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.
Recall details
- Recall number
- Z-2370-2020
- Status
- Terminated
- Initiated by the company
- Mar 25, 2020
- Recalling firm
- Abbott Vascular
- Quantity
- 13 units
- Product code
- NIQ
- Distribution
- US Nationwide distribution including in the states of NJ, HI, MD, FL, NV, CA, KS and PR. No foreign consignee
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,
Code information (models, lots, serial numbers)
Lot Number: 903224A; Device Identifier/GTIN 08717648227455
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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