Boston Scientific Corporation: Medical Device Recall in 2015 - (Recall #: Z-0232-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 17, 2015

Date Posted: November 18, 2015

Recall Number: Z-0232-2016

Event ID: 72225

Reason for Recall:

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

Status: Terminated

Product Quantity: 3

Code Information:

A019995 A020132 A020240

Distribution Pattern:

Distributed in the US to MA and PR.

Voluntary or Mandated:

Voluntary: Firm initiated