FDA Device recall Z-1512-2020
Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibril…
- FDA Device
- Class II
- terminated
- Published 2020-03-25
On 2020-03-25 the FDA classified a Class II recall of Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibril… by Boston Scientific, citing boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed thes….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1512-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-12 |
| Published | 2020-03-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Serial Number 516959 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1512-2020%22
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