Drug recall
EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD…
FDA recall event 77803 · Class II · Boston Scientific Corporation
Key facts
| Event ID | 77803 |
|---|---|
| Recall numbers | Z-3037-2017, Z-3038-2017, Z-3039-2017 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening…, 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device can deliver an atypical amount of energy due to memory corruption inside the device. |
| Initiation date | Jun 29, 2017 |
| Report date | Aug 23, 2017 |
| Termination date | Feb 21, 2019 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 2124215 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: