Z-2151-2017Class I

Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold...

Name: Z-2151-2017 Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold...
Creator: Abbott Vascular
Published: 2017-04-26
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2017-04-26 / Terminated

FDA source

Abbott Vascular began a recall of Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that... on 2017-04-26. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2151-2017
Classification: Class I
Status: Terminated
Initiated: 2017-04-26
Posted: 2017-06-01
Terminated: 2017-11-16
Recalling firm: Abbott Vascular
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.
Product code: PNY Absorbable Coronary Drug-Eluting Stent
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.
FDA root cause: Other
Action: Abbott Vascular sent an Urgent Medical Device Recall and Hazard Alert letter dated April 26, 2017, to affected customers to inform them that the action is in response to recent concerns over data from some 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. Customers were informed of the actions to be taken. Customers were instructed to stop using these devices immediately, advise BVS patients to follow the recommendations for DAPT prescribed by their health care provider. Advise patients experiencing new cardiac symptoms to seek clinical care, review their inventory and complete the attached Facsimile Reply Form and display and share this notification with other relevant personnel within their organization. Customers with questions are instructed to contact their local Abbott Vascular Representative or Customer Service department.
Quantity in commerce: 590 units
Distribution: Australia
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2151-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2151-2017	Class I	Terminated	Voluntary: Firm initiated	2017-06-07	2017-06-01

Product code PNY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)