Boston Scientific — Class II medical device recall Z-1512-2020
Terminated recall by Boston Scientific Corporation, reported 2020-03-25, distributed nationwide. Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model
| Recall number | Z-1512-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2020-02-12 |
| Classified | 2020-03-18 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2023-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 1 devices |
| Reason classes | software |
| Serial numbers | 516959 |
| Model numbers | D152 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1512-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.