Reported Apr 28, 2021 · Terminated
BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - Product Usage: intended to provide…
BIOTRONIK Inc.
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: BIOTRONIK Inc · 6024 Jean Rd · Lake Oswego, OR · 97035-5571
Is this the product you have?
BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRIREF 429559
- UDI04035479156855 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
8473623184737026847373158473756084738576847448648474487284745476847480088474884384749243847492468475139484751632847535548475516784761228
- Serial Number
- Amount recalled
- 17 UNITS
This recall covers 25 products
The agency filed one notice per product. You are reading one of them; the other 24 are below.
12 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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