Boston Scientific Corporation recalls Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA an…

Recall date

December 10, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0621-2016

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

International Distribution to countries of: COLOMBIA, JAMAICA, TRINIDAD & TOBAGO.

Why it was recalled

The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.