Reported Apr 28, 2021 · Terminated
BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provide ventricular…
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 Ilestro 7 VR-T DXDF-1REF 383594
- UDI04035479125509 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
3,259 of 3,259 codes
607030036070335360703354607039366070394060703948607042886070429160704298607043066070430760704309607043156070450360704504607045096070451060704517607045196070452260704756607047596070476360704765607047676070476860704772607047746070531660705327607053296070533060705334607053386070534060705345607053676070536860705370607053716070564260705649607056526070566660705670607056766070570760705715607062246070623260706233607070486070705260707053607070546070706060707063607070646070706560707066
- Serial Number
- Amount recalled
- 3664 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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