Boston Scientific SQ-RX Subcutaneous Pulse Generator Recall for Telemetry Issues
Boston Scientific is recalling three SQ-RX Model 1010 subcutaneous pulse generators shipped in dual-channel mode. This configuration may delay initial telemetry scans but does not affect therapy delivery.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source explicitly states that therapy delivery is not impacted, and the issue is limited to a potential delay in establishing telemetry during the initial scan, which can be resolved with additional scans. This fits the criteria for a moderate severity issue involving a functional limitation without reported injury or therapy failure.
Plain-English summary
Boston Scientific Corporation is recalling three units of the SQ-RX Model 1010 subcutaneous pulse generator (S-ICD). These devices are intended to provide defibrillation therapy. The recall involves specific units identified by codes A019995, A020132, and A020240.
The devices were shipped to the United States in a dual-channel RF Telemetry communication mode rather than the US-approved single-channel mode. This configuration does not impact the delivery of defibrillation therapy. However, it may affect the likelihood of successfully establishing telemetry during the first scan when using a single-channel programmer. Telemetry can be established with additional scans, and once established, no further difficulty is expected.
The affected devices were distributed in the US to Massachusetts and Puerto Rico. Patients with these specific devices should contact their healthcare provider or Boston Scientific for further instructions regarding telemetry scanning.
The recalled product
- Product
- Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- A019995 A020132 A020240
Distribution
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