Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS Recalled by Abbott Vascular Due to Abbott Vascular is initiating a recall of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Vascular directly.
Affected Products
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 disease due to de novo native coronary artery lesions. The treated lesion length should be less than the nominal scaffolding length (8 mm, 12 mm, 18 mm, 23 mm, 28 mm) with reference vessel diameters e 2.0 mm and d 3.8 mm.
Quantity: 590 units
Why Was This Recalled?
Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System due to studies showing elevated rates of major adverse events, specifically, myocardial infraction and scaffold thrombosis when compared to patients treated with the Xience metallic drug eluting stent.
Where Was This Sold?
Australia
About Abbott Vascular
Abbott Vascular has 37 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report