Biotronik Inventa 7 ICDs Recalled for Premature Battery Depletion
Biotronik is recalling Inventa 7 ICDs and CRT-Ds due to a potential for premature battery depletion. The recall covers devices distributed nationwide and worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a life-sustaining medical device (ICD/CRT-D) with a risk of premature battery depletion, which aligns with the 'Severe' criteria for significant injury risk or structural defects in critical devices.
Plain-English summary
Biotronik Inc is recalling specific units of the BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The recall is issued because there is a potential for premature battery depletion in these devices. The affected products are intended to provide ventricular tachycardia pacing and ventricular defibrillation for the automatic treatment of life-threatening ventricular arrhythmias.
The recall includes devices with reference number 399436 and UDI 04035479136314. A comprehensive list of affected serial numbers is provided in the official recall documentation. The distribution pattern for these devices is nationwide in the United States and worldwide.
Consumers and healthcare providers should verify if their specific device serial number is included in the recall list. Patients with implanted devices should contact their healthcare provider or Biotronik Inc for guidance on monitoring and potential replacement options.
The recalled product
- Product
- BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
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.
See all 25 products in this recall →Related recalls
Same manufacturer · BIOTRONIK Inc
See all →- HighBiotronik Inventa 7 ICDs Recalled for Premature Battery Depletion
FDA (Devices) · 2021-04-28
- SevereBIOTRONIK Ilestro 7 VR-T DX Defibrillators Recalled for Battery Depletion
FDA (Devices) · 2021-04-28
- HighBiotronik ILIVIA Neo 7 VR-T DF-1 ProMRI Recall for Battery Depletion
FDA (Devices) · 2021-04-28
- HighBiotronik Intica Neo 7 VR-T DX DF-1 ProMRI Recall for Battery Depletion
FDA (Devices) · 2021-04-28
- SevereBiotronik Inventa 7 Defibrillators Recalled for Premature Battery Depletion
FDA (Devices) · 2021-04-28
Same hazard · battery depletion
See all →- ModerateAllura Xper FD20 OR Table systems recalled over BIOS battery depletion
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- ModerateAllura Xper FD10/10 X-ray systems recalled for BIOS battery startup failure
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- ModerateAllura Xper FD20/20 X-ray systems recalled for BIOS battery startup failure
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- ModerateAllura Xper CV20 X-ray systems recalled after BIOS battery halts startup
FDA (Devices) · 2025-10-08
- ModerateAllura Xper FD20/15 OR Table systems recalled over BIOS battery depletion
FDA (Devices) · 2025-10-08
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