Biotronik Intica Neo 7 HF-T Defibrillators Recalled for Battery Depletion
Biotronik is recalling eight Intica Neo 7 HF-T implantable defibrillators due to a potential for premature battery depletion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (ICD) with a potential for premature battery depletion, which is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Biotronik Inc is recalling eight units of the Intica Neo 7 HF-T DF-1 IS-1 ProMRI implantable cardioverter defibrillator (ICD). The recall is due to a potential for premature battery depletion in these devices.
The affected devices are intended to provide ventricular tachycardia pacing and ventricular defibrillation for the automatic treatment of life-threatening ventricular arrhythmias. The recall covers eight specific units with serial numbers 84737505, 84737521, 84738497, 84738498, 84738995, 84738997, 84739001, and 84739004.
These devices were distributed nationwide in the United States and worldwide. Patients with these specific devices should contact their healthcare provider or Biotronik for further instructions regarding the recall.
The recalled product
- Product
- BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
- Hazard
- Affected units
- 8
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by BIOTRONIK Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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