PMA · Approved
Recalled · Class I · 2026Contak Renewal Models H125 and H120 with the Model 2865 Version 1.8 Application Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corp. · NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Approved on Jan 26, 2004 through premarket approval, which rests on the device’s own clinical evidence after a 308-day review. It has a Class I recall. It has been recalled 20 times, including 11 Class I recalls.
- Decided
- Jan 26, 2004
- Review
- 308 days
- Class
- Class III
- Product code
- NKE
- Recalls
- 20 (11 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P030005 has 244 supplements since 2004: 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 |
|---|---|
| 2004 | 5 |
| 2005 | 16 |
| 2006 | 11 |
| 2007 | 9 |
| 2008 | 6 |
| 2009 | 5 |
| 2010 | 10 |
| 2011 | 9 |
| 2012 | 11 |
| 2013 | 12 |
| 2014 | 10 |
| 2015 | 15 |
| 2016 | 16 |
| 2017 | 23 |
| 2018 | 8 |
| 2019 | 14 |
| 2020 | 13 |
| 2021 | 11 |
| 2022 | 11 |
| 2023 | 8 |
| 2024 | 9 |
| 2025 | 6 |
| 2026 | 6 |
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 |
|---|---|---|---|---|
| Mar 19, 2026 | Class I | Z-1771-2026 | Nonconforming Material/Component | Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all… |
| Aug 20, 2025 | Class I | Z-0103-2026 | Other | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT… |
| Aug 20, 2025 | Class I | Z-0101-2026 | Other | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT… |
| Aug 20, 2025 | Class I | Z-0104-2026 | Other | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT… |
| Aug 20, 2025 | Class I | Z-0105-2026 | Other | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT… |
| Aug 20, 2025 | Class I | Z-0102-2026 | Other | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT… |
| Dec 12, 2024 | Class I | Z-0826-2025 | Process design | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery… |
| Dec 12, 2024 | Class I | Z-0827-2025 | Process design | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery… |
| Jun 3, 2021 | Class I | Z-2019-2021 | Device Design | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits… |
| Jun 3, 2021 | Class I | Z-2018-2021 | Device Design | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits… |
| Jun 3, 2021 | Class I | Z-2020-2021 | Device Design | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits… |
| Jun 3, 2021 | Class II | Z-2002-2021 | Nonconforming Material/Component | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of… |
| Jun 3, 2021 | Class II | Z-2003-2021 | Nonconforming Material/Component | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of… |
| Sep 10, 2018 | Class II | Z-3259-2018 | Component design/selection | Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion. |
| Sep 10, 2018 | Class II | Z-3258-2018 | Component design/selection | Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion. |
| Dec 7, 2017 | Class II | Z-0365-2018 | Device Design | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). |
| Dec 7, 2017 | Class II | Z-0360-2018 | Device Design | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). |
| Dec 7, 2017 | Class II | Z-0361-2018 | Device Design | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). |
| Dec 7, 2017 | Class II | Z-0366-2018 | Device Design | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). |
| Jun 24, 2006 | Not classified | Z-1298-06 | Other | Guidant has determined that low-voltage capacitors from a single component supplier may malfunction in a manner that can lead to premature battery depletion without warning in the affected devices. |
The 5 latest of 20 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NKE devicesNKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NKE
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKE
Too few NKE 510(k)s in any year since 2007 to give a median.
Recalls per year · NKE
5in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · NKE
1,939in 2025
MAUDE reports naming product code NKE, 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 | 19 | — | 0 | 37 |
| 2008 | 24 | — | 0 | 52 |
| 2009 | 22 | — | 0 | 81 |
| 2010 | 27 | — | 0 | 169 |
| 2011 | 29 | — | 0 | 196 |
| 2012 | 19 | — | 0 | 164 |
| 2013 | 44 | — | 0 | 207 |
| 2014 | 54 | — | 0 | 127 |
| 2015 | 58 | — | 1 | 356 |
| 2016 | 33 | — | 0 | 514 |
| 2017 | 48 | — | 7 | 607 |
| 2018 | 29 | — | 0 | 1,004 |
| 2019 | 29 | — | 0 | 794 |
| 2020 | 30 | — | 0 | 806 |
| 2021 | 26 | — | 0 | 1,177 |
| 2022 | 24 | — | 0 | 1,290 |
| 2023 | 27 | — | 0 | 1,469 |
| 2024 | 23 | — | 2 (2) | 1,518 |
| 2025 | 22 | — | 5 (5) | 1,939 |
| 2026 | 19 | — | 1 (1) | — |
https://510kreport.com/device/P030005 · printed Nov 6, 2026
Cite this page
510(k) Report. “P030005: Contak Renewal Models H125 and H120 with the Model 2865 Version 1.8 Application Software.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P030005
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026