Home › Device types › LWS
Implantable Cardioverter Defibrillator (Non-Crt)
FDA product code LWS · Class 3 · Unknown
444
Registered devices
379,337
Adverse events
219
Recalls
0
510(k) clearances
Devices with this code
Rivacor 7 VR-T DF4 ProMRI — BIOTRONIK SE & Co. KGLATITUDE® Communicator — BOSTON SCIENTIFIC CORPORATIONIforia 7 VR-T — BIOTRONIK SE & Co. KGINOGEN™ EL ICD DR — BOSTON SCIENTIFIC CORPORATIONEMBLEM™ S-ICD Programmer — BOSTON SCIENTIFIC CORPORATIONORIGEN™ EL ICD DR — BOSTON SCIENTIFIC CORPORATIONSprint Quattro Secure S MRI™ SureScan™ — MEDTRONIC, INC.Evera™ S DR — MEDTRONIC, INC.Cobalt™ DR MRI SureScan™ — MEDTRONIC, INC.Sprint Quattro® — MEDTRONIC, INC.PERCIVA™ ICD VR — BOSTON SCIENTIFIC CORPORATIONSprint Quattro Secure® — MEDTRONIC, INC.Iperia 5 VR-T — BIOTRONIK SE & Co. KGEvera™ S VR — MEDTRONIC, INC.NA — BOSTON SCIENTIFIC CORPORATIONDYNAGEN™ MINI ICD DR — BOSTON SCIENTIFIC CORPORATIONNA — BOSTON SCIENTIFIC CORPORATIONVisia AF MRI™ VR SureScan™ — MEDTRONIC, INC.CareLink® Network — MEDTRONIC, INC.Evera MRI™ XT DR SureScan® — MEDTRONIC, INC.Rivacor Rise VR-T DX — BIOTRONIK SE & Co. KGINOGEN™ MINI ICD DR — BOSTON SCIENTIFIC CORPORATIONNA — ST. JUDE MEDICAL, INC.NA — BOSTON SCIENTIFIC CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-29 | Medtronic, Inc. | There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur. |
| 2025-08-20 | Boston Scientific Corporation | 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 |
| 2025-07-24 | Boston Scientific Corporation | Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to |
| 2024-04-16 | Medtronic Inc. | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. |
| 2024-04-16 | Medtronic Inc. | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. |
| 2024-04-16 | Medtronic Inc. | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. |
| 2024-04-16 | Medtronic Inc. | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. |
| 2024-04-16 | Medtronic Inc. | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. |
| 2024-04-16 | Medtronic Inc. | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. |
| 2024-04-16 | Medtronic Inc. | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. |
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