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

FDA device recall Z-2151-2017 · posted 2017-06-01 · Terminated

Recall details

Recalling firm

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

PNY

Quantity affected

590 units

Distribution

Australia

Date initiated

2017-04-26

Date posted

2017-06-01

Date terminated

2017-11-16

Location

Temecula, CA