# P980035: Medtronic Kappa 700/600 Series Pulse Generators and Model 9953 Software

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Jan 29, 1999 after 157 days
- Product code: NVZ (Pulse Generator, Permanent, Implantable)
- Device class: 3
- Recalls of this device: 16 (6 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
- Apr 29, 2025 · Class II · Z-1924-2025: 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 lea
- Jun 4, 2020 · Class II · Z-2507-2020: 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 measurem
- Jun 4, 2020 · Class II · Z-2508-2020: 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 measurem
- Jun 4, 2020 · Class II · Z-2509-2020: 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 measurem
- Jun 4, 2020 · Class II · Z-2510-2020: 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 measurem
- Jan 17, 2019 · Class I · Z-0807-2019: 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
- Jan 17, 2019 · Class I · Z-0808-2019: 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
- Jan 17, 2019 · Class I · Z-0809-2019: 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
- Jan 17, 2019 · Class I · Z-0811-2019: 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
- Jan 17, 2019 · Class I · Z-0806-2019: 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
- Jan 17, 2019 · Class I · Z-0810-2019: 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
- Apr 4, 2011 · Not classified · Z-2120-2011: 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, EnPul
- Feb 11, 2010 · Not classified · Z-1440-2010: 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
- May 18, 2009 · Not classified · Z-1515-2009: 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,

Source page: https://510kreport.com/device/P980035
Methodology: https://510kreport.com/methodology