Reported Mar 25, 2020 · Terminated
Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 4100 Hamline Ave N Bldg 3 · Saint Paul, MN · 55112-5700
Is this the product you have?
- Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR
- Model D152 - Product UsageImplantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number 516959
- Amount recalled
- 1 device
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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