Boston Scientific Corporation Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Serial Number 516959
Products Sold
Serial Number 516959
Boston Scientific Corporation is recalling Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product U due to Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update A. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.
Recommended Action
Per FDA guidance
The firm initiated the recall by letter on 12/12/2020. The letter explained the error and requested the consignee segregate the units for removal. The firm will provide another model of programmer to be used in the interim.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026