Implantable Cardioverter Defibrillator (non-crt)

Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4

There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.

Model Number L101, ESSENTIO DR SL Pacemaker

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0

Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.

EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.