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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Australia: Part 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Abbott Vascular
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Australia: Part 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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2151-2017
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