SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing
Reported: August 23, 2017 Initiated: June 29, 2017 #Z-3039-2017
Product Description
SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing
Reason for Recall
The device can deliver an atypical amount of energy due to memory corruption inside the device.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- Approximately 12,450 devices
- Distribution
- Worldwide - US Nationwide distribution, including Puerto Rico, U.S. Virgin Island, and Guam, There was also worldwide foreign distribution, including Canada.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing. Recalled by Boston Scientific Corporation. Units affected: Approximately 12,450 devices.
Why was this product recalled? ▼
The device can deliver an atypical amount of energy due to memory corruption inside the device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 23, 2017. Severity: Moderate. Recall number: Z-3039-2017.
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