Abbott Vascular Recalls Xience Sierra Stents Due to Incorrect Expiration Date
Abbott Vascular is recalling 13 units of Xience Sierra coronary stents because they bear an incorrect expiration date.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a documentation error (incorrect expiration date) with no reported injuries or illnesses, fitting the criteria for a Low severity recall.
Plain-English summary
Abbott Vascular is recalling 13 units of the Xience Sierra TM Everolimus Eluting Coronary Stent System, size 3.5mm x 33mm, Lot 903224A. The recall was initiated because the devices bear an incorrect expiration date.
The affected units were distributed nationwide in the United States, including in New Jersey, Hawaii, Maryland, Florida, Nevada, California, Kansas, and Puerto Rico. No foreign consignees are listed for this recall.
Consumers and healthcare providers should stop using the affected stents and contact Abbott Vascular for further instructions or a replacement.
The recalled product
- 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,
- Manufacturer
- Abbott Vascular
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 13
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number: 903224A
- Device Identifier/GTIN 08717648227455
Distribution
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