CLASS II Device recall · Reported 28 Apr 2021 · FDA Enforcement Report

Intica Neo 7 Vr-t DX Df-1 ProMRI recalled by Biotronik

Biotronik is recalling Biotronik Intica Neo 7 Vr-t DX Df-1 ProMRI, distributed nationwide in the US. The recall was initiated on 8 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number 84736231 84737026 84737315 84737560 84738576 84744864 84744872 84745476 84748008 84748843 84749243 84749246 84751394 84751632 84753554 84755167 84761228

Quantity recalled17 UNITS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1463-2021
FDA event ID: 87549
Recalling firm: Biotronik, Lake Oswego, OR
Classification: Class II
Status: Terminated
Recall initiated: 8 Mar 2021
FDA classified: 21 Apr 2021
Reported: 28 Apr 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

8 Mar 2021	Recall initiated by company
21 Apr 2021	Classified by FDA	+44 days
28 Apr 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

Where it was distributed

US: Nationwide OUS: Worldwide

Nationwide

Questions about this recall

Is Intica Neo 7 Vr-t DX Df-1 ProMRI recalled?

Yes. Biotronik recalled Intica Neo 7 Vr-t DX Df-1 ProMRI on 8 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1463-2021.

Why was it recalled?

There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)

Which lots are affected?

Serial Number 84736231 84737026 84737315 84737560 84738576 84744864 84744872 84745476 84748008 84748843 84749243 84749246 84751394 84751632 84753554 84755167 84761228

Where was it sold?

US: Nationwide OUS: Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Biotronik

All 26

Reported	Class	Recall	Company	Reason	Where
28 Apr 2021Device	CLASS II	Itrevia 7, Vr-t Dx Df recalled by Biotronik	Biotronik	Device Malfunction	Nationwide
28 Apr 2021Device	CLASS II	Iperia 7, Dr-t DF4 ProMRI recalled by Biotronik	Biotronik	Device Malfunction	Nationwide
28 Apr 2021Device	CLASS II	Inventra 7, Vr-t DX Df-1 ProMRI recalled by Biotronik	Biotronik	Device Malfunction	Nationwide
28 Apr 2021Device	CLASS II	Ilivia 7, Vr-t Df-1 ProMRI recalled by Biotronik	Biotronik	Device Malfunction	Nationwide
28 Apr 2021Device	CLASS II	Inventra 7, Vr-t Dx Df recalled by Biotronik	Biotronik	Device Malfunction	Nationwide

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