Z-3037-2017 Class II Terminated
FDA device recall Z-3037-2017 was initiated by Boston Scientific Corporation on Jun 29, 2017 and is designated Class II. Reason for recall: The device can deliver an atypical amount of energy due to memory corruption inside the device. The recall status is terminated (terminated Feb 21, 2019). Affected quantity: Approximately 16,750 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 23, 2017
- Initiation Date
- Jun 29, 2017
- Termination Date
- Feb 21, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Approximately 16,750 devices
Product Description
EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, 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.
Distribution Pattern
Worldwide - US Nationwide distribution, including Puerto Rico, U.S. Virgin Island, and Guam, There was also worldwide foreign distribution, including Canada.
Code Information
All serial numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3037-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026