The Recall Desk

Manufacturer

BIOTRONIK, Inc.

26 recalls in our database name BIOTRONIK, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
26
Critical
0
Severe
5
Most recent
2021-04-28

Of the 26 recalls from BIOTRONIK, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (19%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 26

  • SevereFDA (Devices)·Z-1460-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1444-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1459-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1445-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1448-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1443-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1446-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1461-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1458-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1452-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1453-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1451-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1457-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1455-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1441-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1465-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1462-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1456-2021·2021-04-28

    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
    Medical Device
    Distribution
    Distributed nationwide