PMA · Approved
Recalled · Class I · 2025Virtuso/Entrust/Maximo/Intrinsic/Marquis/Implantable Cardiverter Defibrillators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Cardiac Rhythm Disease Management · LWS Implantable Cardioverter Defibrillator (Non-Crt)
Approved on Oct 9, 1998 through premarket approval, which rests on the device’s own clinical evidence after a 151-day review. It has a Class I recall. It has been recalled 14 times, including 3 Class I recalls.
- Decided
- Oct 9, 1998
- Review
- 151 days
- Class
- Class III
- Product code
- LWS
- Recalls
- 14 (3 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P980016 has 933 supplements since 1999: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1999 | 9 |
| 2000 | 4 |
| 2001 | 9 |
| 2002 | 6 |
| 2003 | 10 |
| 2004 | 6 |
| 2005 | 11 |
| 2006 | 28 |
| 2007 | 26 |
| 2008 | 44 |
| 2009 | 47 |
| 2010 | 50 |
| 2011 | 61 |
| 2012 | 55 |
| 2013 | 60 |
| 2014 | 64 |
| 2015 | 43 |
| 2016 | 51 |
| 2017 | 43 |
| 2018 | 44 |
| 2019 | 27 |
| 2020 | 40 |
| 2021 | 36 |
| 2022 | 37 |
| 2023 | 35 |
| 2024 | 32 |
| 2025 | 34 |
| 2026 | 21 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 17, 2025 | Class II | Z-2128-2025 | Software design | 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 interrogation with a SmartSync Device… |
| Jun 17, 2025 | Class II | Z-2127-2025 | Software design | 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 interrogation with a SmartSync Device… |
| May 10, 2023 | Class I | Z-1801-2023 | Under Investigation by firm | 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 defibrillators (CRT-Ds) manufactured… |
| May 10, 2023 | Class I | Z-1802-2023 | Under Investigation by firm | 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 defibrillators (CRT-Ds) manufactured… |
| Feb 3, 2021 | Class I | Z-1305-2021 | Device Design | 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-expected RRT observation |
| Jun 21, 2018 | Class II | Z-2419-2018 | Device Design | 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 replacement indicator (ERI) voltage. Under… |
| Jun 21, 2018 | Class II | Z-2418-2018 | Device Design | 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 replacement indicator (ERI) voltage. Under… |
| Jun 21, 2018 | Class II | Z-2420-2018 | Device Design | 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 replacement indicator (ERI) voltage. Under… |
| Jun 21, 2018 | Class II | Z-2416-2018 | Device Design | 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 replacement indicator (ERI) voltage. Under… |
| Jun 21, 2018 | Class II | Z-2417-2018 | Device Design | 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 replacement indicator (ERI) voltage. Under… |
| Jun 21, 2018 | Class II | Z-2421-2018 | Device Design | 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 replacement indicator (ERI) voltage. Under… |
| Jul 25, 2008 | Not classified | Z-0665-2009 | Process design | 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 daily pacing thresholds and may increase… |
| Jul 25, 2008 | Not classified | Z-0666-2009 | Process design | 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 daily pacing thresholds and may increase… |
| Apr 2, 2004 | Not classified | Z-0812-04 | Other | 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 conditions as the battery voltage nears… |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LWS devicesLWS Implantable Cardioverter Defibrillator (Non-Crt): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWS
97in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LWS
Too few LWS 510(k)s in any year since 2007 to give a median.
Recalls per year · LWS
2in 2025
Class I (12 since 2007) Class II/III not classified
Adverse event reports per year · LWS
24,303in 2025
MAUDE reports naming product code LWS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 70 | — | 4 | 10,330 |
| 2008 | 94 | — | 3 | 11,327 |
| 2009 | 80 | — | 8 | 13,768 |
| 2010 | 119 | — | 6 | 17,321 |
| 2011 | 136 | — | 8 | 15,097 |
| 2012 | 129 | — | 5 | 12,820 |
| 2013 | 148 | — | 1 | 17,242 |
| 2014 | 168 | — | 0 | 18,594 |
| 2015 | 100 | — | 2 (1) | 14,040 |
| 2016 | 145 | — | 2 (2) | 16,638 |
| 2017 | 162 | — | 7 (5) | 18,454 |
| 2018 | 142 | — | 1 | 17,228 |
| 2019 | 98 | — | 0 | 16,184 |
| 2020 | 125 | — | 6 (3) | 16,909 |
| 2021 | 111 | — | 0 | 19,654 |
| 2022 | 91 | — | 3 | 23,454 |
| 2023 | 101 | — | 2 | 28,701 |
| 2024 | 108 | — | 0 | 25,202 |
| 2025 | 97 | — | 2 (1) | 24,303 |
| 2026 | 93 | — | 0 | — |
https://510kreport.com/device/P980016 · printed Nov 6, 2026
Cite this page
510(k) Report. “P980016: Virtuso/Entrust/Maximo/Intrinsic/Marquis/Implantable Cardiverter Defibrillators.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P980016
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026