FDA Device recall Z-1449-2021
BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intended to provide ventricular tachycardia pac…
- FDA Device
- Class II
- terminated
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class II recall of BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intended to provide ventricular tachycardia pac… by Biotronik, citing there is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1449-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-08 |
| Published | 2021-04-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biotronik |
| Distribution | US |
Product
BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Reason
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Identifiers
| code_info | Serial Number 60824541 60825066 60828115 60829523 60829525 60829530 60829531 60829534 60829535 60829536 6082…Serial Number 60824541 60825066 60828115 60829523 60829525 60829530 60829531 60829534 60829535 60829536 60829537 60829538 60829539 60829562 60829569 60831618 60831793 60831798 60831799 60831801 60831802 60831805 60831871 60831886 60831887 60831893 60831918 60831924 60831925 60832194 60833094 60833105 60833106 60833107 60833110 60833112 60833113 60833116 60833119 60833120 60833122 60833130 60833136 60833138 60833146 60833148 60833677 60833687 60833692 60833700 60833701 60833703 60833707 60833708 60833724 60834092 60834093 60834095 60834098 60834103 60834108 60834109 60834112 60834115 60834116 60834117 60834121 60834134 60834147 60834149 60834151 60834156 60834159 60834167 60834190 60834193 60834195 60834198 60834199 60834234 60834238 60834240 60834241 60834245 60834248 60834260 60834457 60834459 60834462 60834464 60834470 60834476 60834478 60834479 60834480 60834490 60834491 60834495 60834 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1449-2021%22
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