Abbott Absorb Bioresorbable Vascular Scaffold Recalled for Elevated Adverse Event Rates
Abbott Vascular is recalling the Absorb Bioresorbable Vascular Scaffold (BVS) System in Australia due to studies showing higher rates of major adverse events, including myocardial infarction and scaffold thrombosis, compared to metallic stents.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I, and the rubric mandates a score of 5 for FDA Class I recalls.
Plain-English summary
Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System. The recall involves 590 units distributed in Australia. The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions.
The recall is being initiated due to studies showing elevated rates of major adverse events, specifically myocardial infarction and scaffold thrombosis, when compared to patients treated with the Xience metallic drug eluting stent. The affected products include various sizes of the Absorb BVS, such as 2.5 x 08 mm, 2.5 x 12 mm, and 3.5 x 28 mm.
Patients who have received the Absorb BVS should contact their healthcare provider for further evaluation and management. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart…
- Manufacturer
- Abbott Vascular
- Category
- Medical Device — Cardiovascular
- Affected units
- 590
Distribution
Distribution scope not specified by the agency.
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