SQ-RX 1010 Pulse Generator recall
SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening…
Why was SQ-RX 1010 Pulse Generator recalled?
The device can deliver an atypical amount of energy due to memory corruption inside the device.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All serial numbers
- Product
- SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 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.
- Recall date
- August 23, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)