Boston Scientific Corporation recalls Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.

Recall date

September 17, 2015

Source

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

Recall number

Z-0232-2016

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

Distributed in the US to MA and PR.

Why it was recalled

Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communication mode. While this does not impact therapy delivery of device; this can impact likelihood of successfully establishing telemetry during first scan of device when using a single-channel programmer. Telemetry can be established with additional scans; once established no further difficulty is expecte

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 SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.