FDA (Devices) recall action 87549

BIOTRONIK Inc recalled 25 products on 2021-04-28

The FDA (Devices) publishes a recall like this one as 25 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 25 pages.

Products: 25
Announced: 2021-04-28
Critical: 0
Units: 25,152

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 25

HighFDA (Devices)··2021-04-28
Biotronik ILIVIA 7 Defibrillators Recalled for Premature Battery Depletion
Biotronik is recalling 779 ILIVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.
Product
BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
Biotronik Inventa 7 ICDs Recalled for Premature Battery Depletion
Biotronik is recalling 702 Inventa 7 ICDs due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.
Product
BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
SevereFDA (Devices)··2021-04-28
BIOTRONIK Ilestro 7 VR-T DX Defibrillators Recalled for Battery Depletion
BIOTRONIK Inc is recalling 3,664 Ilestro 7 VR-T DX implantable defibrillators due to a potential for premature battery depletion.
Product
BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
Biotronik ILIVIA Neo 7 VR-T DF-1 ProMRI Recall for Battery Depletion
Biotronik is recalling 74 ILIVIA Neo 7 VR-T DF-1 ProMRI implantable cardioverter defibrillators due to a potential for premature battery depletion.
Product
BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
Biotronik Intica Neo 7 VR-T DX DF-1 ProMRI Recall for Battery Depletion
Biotronik is recalling 17 Intica Neo 7 VR-T DX DF-1 ProMRI implantable cardioverter defibrillators due to a potential for premature battery depletion.
Product
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.
Category
Distribution
0 states
SevereFDA (Devices)··2021-04-28
Biotronik Inventa 7 Defibrillators Recalled for Premature Battery Depletion
Biotronik Inc is recalling 285 Inventa 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.
Product
BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
Biotronik ILIVIA 7 ICD Recall for Premature Battery Depletion
Biotronik is recalling 3,497 ILIVIA 7 implantable cardioverter defibrillators due to a potential for premature battery depletion. The recall covers units distributed nationwide and worldwide.
Product
BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
Biotronik Ilestro 7 VR-T Defibrillators Recalled for Premature Battery Depletion
Biotronik Inc is recalling 1,000 Ilestro 7 VR-T implantable defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.
Product
BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
Biotronik Iperia 7 Defibrillators Recalled for Premature Battery Depletion
Biotronik is recalling 1,652 Iperia 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.
Product
BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
SevereFDA (Devices)··2021-04-28
BIOTRONIK Iforia 7 Defibrillators Recalled for Premature Battery Depletion
BIOTRONIK is recalling 490 Iforia 7 implantable defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.
Product
BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
Biotronik ILIVIA 7 Defibrillators Recalled for Premature Battery Depletion
Biotronik Inc is recalling 1,547 ILIVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.
Product
BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion
Biotronik is recalling 386 ITREVIA 7 implantable defibrillators due to a potential for premature battery depletion.
Product
BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
Biotronik Ilestro 7 DR-T Recall for Premature Battery Depletion
Biotronik is recalling Ilestro 7 DR-T implantable defibrillators due to a potential for premature battery depletion. Affected devices are distributed nationwide and worldwide.
Product
BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
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.
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.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
BIOTRONIK IPERIA 7 ICDs Recalled for Premature Battery Depletion
BIOTRONIK Inc is recalling 3,832 IPERIA 7 ICDs and CRT-Ds due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.
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.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion
Biotronik is recalling 670 ITREVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.
Product
BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
BIOTRONIK IPERIA 7 ICDs Recalled for Premature Battery Depletion
BIOTRONIK Inc is recalling 2,881 IPERIA 7 ICDs and CRT-Ds due to a potential for premature battery depletion.
Product
BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
Biotronik ILIVIA NEO 7 DR-T DF-1 ProMRI Defibrillators Recalled for Battery Depletion
Biotronik is recalling 98 ILIVIA NEO 7 DR-T DF-1 ProMRI defibrillators due to a potential for premature battery depletion.
Product
BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion
Biotronik is recalling 499 ITREVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.
Product
BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
Biotronik Iforia 7 ICDs Recalled for Premature Battery Depletion
Biotronik Inc is recalling 1,176 Iforia 7 implantable cardioverter defibrillators due to a potential for premature battery depletion.
Product
BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
Biotronik ILIVIA 7 ICDs Recalled for Premature Battery Depletion
Biotronik is recalling 914 ILIVIA 7 ICDs due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.
Product
BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
SevereFDA (Devices)··2021-04-28
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.
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.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion
Biotronik Inc is recalling 658 ITREVIA 7 implantable defibrillators due to a potential for premature battery depletion.
Product
BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
HighFDA (Devices)··2021-04-28
BIOTRONIK Ilestro 7 DR-T ICDs Recalled for Premature Battery Depletion
BIOTRONIK Inc is recalling Ilestro 7 DR-T implantable cardioverter defibrillators due to a potential for premature battery depletion.
Product
BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states
SevereFDA (Devices)··2021-04-28
Biotronik Ilestro 7 VR-T Defibrillators Recalled for Battery Depletion Risk
Biotronik is recalling 323 Ilestro 7 VR-T defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.
Product
BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Category
Distribution
0 states