FDA Device recall Z-2151-2017
Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia)
- FDA Device
- Class I
- terminated
- Published 2017-06-07
On 2017-06-07 the FDA classified a Class I recall of Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia) by Abbott Vascular, citing 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, myoc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2151-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-04-26 |
| Published | 2017-06-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Abbott Vascular |
| Distribution | n/a |
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 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.
Reason
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.
Identifiers
| code_info | Australia: Part No. Description 1012462-08 2.5 x 08 mm Absorb BVS 1012462-12 2.5 x 12 mm Absorb BVS 1012462…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2151-2017%22
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