Reported Apr 28, 2021 · Terminated
BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - 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 IPERIA 7DR-T DF4 ProMRIREF 392423
- UDI04035479128913 -
- Product Usageintended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Serial Number
2,881 of 2,881 codes
608262316082627460826822608345786083459060834592608345956083460260834610608346186083462760834628608346406083570560835712608360056083601560836158608364796083676760836769608367706083677160836775608367766083677760836779608367826083678760836788608368026083680960836812608368246083683060836935608369416083694460836963608369796083698560837879608378896083789260837919608379226083792460837928608379326083801960838020608380566083806060838064608380826083809560838106608381076083811060838382
- Serial Number
- Amount recalled
- 2881 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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