PMA · Approved
Recalled · Class I · 2025Medtronic Kappa 700/600 Series Pulse Generators and Model 9953 Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · NVZ Pulse Generator, Permanent, Implantable
Approved on Jan 29, 1999 through premarket approval, which rests on the device’s own clinical evidence after a 157-day review. It has a Class I recall. It has been recalled 16 times, including 6 Class I recalls.
- Decided
- Jan 29, 1999
- Review
- 157 days
- Class
- Class III
- Product code
- NVZ
- Recalls
- 16 (6 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P980035 has 822 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 | 6 |
| 2000 | 2 |
| 2001 | 8 |
| 2002 | 6 |
| 2003 | 9 |
| 2004 | 8 |
| 2005 | 7 |
| 2006 | 18 |
| 2007 | 14 |
| 2008 | 38 |
| 2009 | 23 |
| 2010 | 48 |
| 2011 | 54 |
| 2012 | 41 |
| 2013 | 56 |
| 2014 | 44 |
| 2015 | 44 |
| 2016 | 35 |
| 2017 | 47 |
| 2018 | 42 |
| 2019 | 38 |
| 2020 | 56 |
| 2021 | 30 |
| 2022 | 37 |
| 2023 | 32 |
| 2024 | 34 |
| 2025 | 25 |
| 2026 | 20 |
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 29, 2025 | Class II | Z-1924-2025 | Process change control | Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or… |
| Jun 4, 2020 | Class II | Z-2507-2020 | Software design | There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead… |
| Jun 4, 2020 | Class II | Z-2508-2020 | Software design | There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead… |
| Jun 4, 2020 | Class II | Z-2509-2020 | Software design | There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead… |
| Jun 4, 2020 | Class II | Z-2510-2020 | Software design | There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead… |
| Jan 17, 2019 | Class I | Z-0807-2019 | Component design/selection | A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a… |
| Jan 17, 2019 | Class I | Z-0808-2019 | Component design/selection | A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a… |
| Jan 17, 2019 | Class I | Z-0809-2019 | Component design/selection | A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a… |
| Jan 17, 2019 | Class I | Z-0811-2019 | Component design/selection | A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a… |
| Jan 17, 2019 | Class I | Z-0806-2019 | Component design/selection | A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a… |
| Jan 17, 2019 | Class I | Z-0810-2019 | Component design/selection | A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a… |
| Apr 4, 2011 | Not classified | Z-2120-2011 | Component design/selection | A rare measurement lock-up condition that may (at a rate of approximately 1 in 18,000 devices) inappropriately trigger ERI/RRT in the Medtronic Dual Chamber Pacemakers: Kappa 600, 700, 800, 900, EnPulse, Adapta, Versa, Sensia. This is… |
| Feb 11, 2010 | Not classified | Z-1440-2010 | Nonconforming Material/Component | Medtronic is informing doctors of two specific battery issues with EnRhythm pacemakers that will be addressed by a Medtronic software update available mid-2010. If the software update referenced above is not implemented, there will be a… |
| May 18, 2009 | Not classified | Z-1515-2009 | Device Design | One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output. |
The 5 latest of 16 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NVZ devicesNVZ Pulse Generator, Permanent, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NVZ
39in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NVZ
Too few NVZ 510(k)s in any year since 2007 to give a median.
Recalls per year · NVZ
2in 2024
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · NVZ
5,970in 2025
MAUDE reports naming product code NVZ, 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 | 124 | — | 2 | 85 |
| 2008 | 164 | — | 1 | 142 |
| 2009 | 124 | — | 4 | 245 |
| 2010 | 181 | — | 1 | 4,039 |
| 2011 | 178 | — | 1 | 6,334 |
| 2012 | 130 | — | 0 | 5,562 |
| 2013 | 131 | — | 0 | 4,033 |
| 2014 | 122 | — | 1 | 3,107 |
| 2015 | 88 | — | 0 | 2,773 |
| 2016 | 76 | — | 0 | 2,558 |
| 2017 | 61 | — | 2 | 3,164 |
| 2018 | 59 | — | 0 | 5,878 |
| 2019 | 60 | — | 7 (7) | 8,188 |
| 2020 | 73 | — | 0 | 8,337 |
| 2021 | 40 | — | 1 | 8,538 |
| 2022 | 44 | — | 0 | 7,791 |
| 2023 | 39 | — | 0 | 8,463 |
| 2024 | 42 | — | 2 | 6,496 |
| 2025 | 39 | — | 0 | 5,970 |
| 2026 | 24 | — | 3 | — |
https://510kreport.com/device/P980035 · printed Nov 6, 2026
Cite this page
510(k) Report. “P980035: Medtronic Kappa 700/600 Series Pulse Generators and Model 9953 Software.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P980035
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026