Reported Apr 28, 2021 · Terminated
BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - 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 IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032
- UDI04035479129477 -
- 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
608245416082506660828115608295236082952560829530608295316082953460829535608295366082953760829538608295396082956260829569608316186083179360831798608317996083180160831802608318056083187160831886608318876083189360831918608319246083192560832194608330946083310560833106608331076083311060833112608331136083311660833119608331206083312260833130608331366083313860833146608331486083367760833687608336926083370060833701608337036083370760833708608337246083409260834093608340956083409860834103
- Serial Number
- Amount recalled
- 3,832 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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