Reported Jun 7, 2017 · Terminated
Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for…
Abbott Vascular
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Vascular · 26531 Ynez Rd · Temecula, CA · 92591-4630
Is this the product you have?
- 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.
- Lot codes and dates
- AustraliaPart No. Description 1012462-08 2.5 x 08 mm Absorb BVS 1012462-12 2.5 x 12 mm Absorb BVS 1012462-18 2.5 x 18 mm Absorb BVS 1012462-23 2.5 x 23 mm Absorb BVS 1012462-28 2.5 x 28 mm Absorb BVS 1012463-08 3.0 x 08 mm Absorb BVS 1012463-12 3.0 x 12 mm Absorb BVS 1012463-18 3.0 x 18 mm Absorb BVS 1012463-23 3.0 x 23 mm Absorb BVS 1012463-28 3.0 x 28 mm Absorb BVS 1012464-12 3.5 x 12 mm Absorb BVS 1012464-18 3.5 x 18 mm Absorb BVS 1012464-23 3.5 x 23 mm Absorb BVS 1012464-28 3.5 x 28 mm Absorb BVS
- Amount recalled
- 590 units
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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