# P980016: Virtuso/Entrust/Maximo/Intrinsic/Marquis/Implantable Cardiverter Defibrillators

- Pathway: PMA
- Applicant: Medtronic Cardiac Rhythm Disease Management
- Decided: Oct 9, 1998 after 151 days
- Product code: LWS (Implantable Cardioverter Defibrillator (Non-Crt))
- Device class: 3
- Recalls of this device: 14 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jun 17, 2025 · Class II · Z-2128-2025: A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon inter
- Jun 17, 2025 · Class II · Z-2127-2025: A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon inter
- May 10, 2023 · Class I · Z-1801-2023: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy de
- May 10, 2023 · Class I · Z-1802-2023: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy de
- Feb 3, 2021 · Class I · Z-1305-2021: A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-ex
- Jun 21, 2018 · Class II · Z-2419-2018: Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replac
- Jun 21, 2018 · Class II · Z-2418-2018: Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replac
- Jun 21, 2018 · Class II · Z-2420-2018: Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replac
- Jun 21, 2018 · Class II · Z-2416-2018: Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replac
- Jun 21, 2018 · Class II · Z-2417-2018: Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replac
- Jun 21, 2018 · Class II · Z-2421-2018: Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replac
- Jul 25, 2008 · Not classified · Z-0665-2009: Maximo II VR ICD, DR ICD and CRT-D inadvertently include the Capture Management algorithm (Atrial/Right Ventricular/Left Ventricular Capture management). The Capture management algorithm monitors dail
- Jul 25, 2008 · Not classified · Z-0666-2009: Maximo II VR ICD, DR ICD and CRT-D inadvertently include the Capture Management algorithm (Atrial/Right Ventricular/Left Ventricular Capture management). The Capture management algorithm monitors dail
- Apr 2, 2004 · Not classified · Z-0812-04: Some of the devices with suspect capacitors (high voltage capacitors associated with prior notifications in 1999 and in 2000) have had unexpected charge circuit time-outs or charge circuit inactive co

Source page: https://510kreport.com/device/P980016
Methodology: https://510kreport.com/methodology