PMA · Approved
Recalled · Class I · 2025Concerto/Insync Sentry/Insync Maximo Implantable Cardiovascular Defibrillators with Cardiac Resynchicnization
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Cardiac Rhythm Disease Management · NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Approved on Jun 26, 2002 through premarket approval, which rests on the device’s own clinical evidence after a 418-day review. It has a Class I recall. It has been recalled 11 times, including a Class I recall.
- Decided
- Jun 26, 2002
- Review
- 418 days
- Class
- Class III
- Product code
- NIK
- Recalls
- 11 (1 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P010031 has 902 supplements since 2002: 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 |
|---|---|
| 2002 | 2 |
| 2003 | 8 |
| 2004 | 7 |
| 2005 | 9 |
| 2006 | 25 |
| 2007 | 30 |
| 2008 | 41 |
| 2009 | 41 |
| 2010 | 44 |
| 2011 | 61 |
| 2012 | 52 |
| 2013 | 69 |
| 2014 | 67 |
| 2015 | 41 |
| 2016 | 49 |
| 2017 | 44 |
| 2018 | 41 |
| 2019 | 30 |
| 2020 | 41 |
| 2021 | 40 |
| 2022 | 38 |
| 2023 | 34 |
| 2024 | 32 |
| 2025 | 35 |
| 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… |
| Apr 6, 2021 | Class II | Z-1528-2021 | Software design | A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted. |
| Apr 6, 2021 | Class II | Z-1526-2021 | Software design | A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted. |
| Apr 6, 2021 | Class II | Z-1527-2021 | Software design | A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted. |
| Apr 6, 2021 | Class II | Z-1525-2021 | Software design | A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted. |
| Feb 3, 2021 | Class I | Z-1306-2021 | 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 |
| Nov 15, 2020 | Class II | Z-0928-2021 | Process control | Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function. |
| Nov 15, 2020 | Class II | Z-0926-2021 | Process control | Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function. |
| Nov 15, 2020 | Class II | Z-0927-2021 | Process control | Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function. |
| Jul 25, 2008 | Not classified | Z-0667-2009 | 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… |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NIK devicesNIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NIK
56in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NIK
Too few NIK 510(k)s in any year since 2007 to give a median.
Recalls per year · NIK
1in 2022
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · NIK
10,855in 2025
MAUDE reports naming product code NIK, 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 | 53 | — | 9 | 924 |
| 2008 | 62 | — | 1 | 3,021 |
| 2009 | 43 | — | 2 | 4,177 |
| 2010 | 51 | — | 7 | 5,668 |
| 2011 | 50 | — | 0 | 5,944 |
| 2012 | 83 | — | 2 | 5,582 |
| 2013 | 50 | — | 0 | 7,373 |
| 2014 | 76 | — | 0 | 10,731 |
| 2015 | 49 | — | 0 | 7,828 |
| 2016 | 109 | — | 2 (1) | 13,255 |
| 2017 | 112 | — | 9 (5) | 16,265 |
| 2018 | 91 | — | 0 | 8,348 |
| 2019 | 62 | — | 0 | 7,266 |
| 2020 | 75 | — | 3 | 9,609 |
| 2021 | 67 | — | 0 | 10,134 |
| 2022 | 62 | — | 1 | 10,646 |
| 2023 | 58 | — | 0 | 11,897 |
| 2024 | 56 | — | 0 | 11,697 |
| 2025 | 56 | — | 0 | 10,855 |
| 2026 | 44 | — | 0 | — |
https://510kreport.com/device/P010031 · printed Nov 6, 2026
Cite this page
510(k) Report. “P010031: Concerto/Insync Sentry/Insync Maximo Implantable Cardiovascular Defibrillators with Cardiac Resynchicnization.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P010031
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026