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Recall Observatory FDA recall evidence

Device product

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

Z-0232-2016

September 17, 2015

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 72225
Status
Terminated
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-0232-2016

Official wording

Reason: 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

Code information: A019995 A020132 A020240

Distribution pattern: Distributed in the US to MA and PR.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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