PMA · Approved
Recalled · Class II · 2022Accent, Identity, Verity, Victory and Zephyr Pacemakers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · DXY Implantable Pacemaker Pulse-Generator
Approved on Aug 21, 1989 through premarket approval, which rests on the device’s own clinical evidence after a 279-day review. It has been recalled 9 times.
- Decided
- Aug 21, 1989
- Review
- 279 days
- Class
- Class III
- Product code
- DXY
- Recalls
- 9
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P880086 has 328 supplements since 1989: 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 |
|---|---|
| 1989 | 1 |
| 1990 | 5 |
| 1991 | 7 |
| 1992 | 3 |
| 1993 | 4 |
| 1994 | 6 |
| 1995 | 7 |
| 1996 | 2 |
| 1997 | 5 |
| 1998 | 7 |
| 1999 | 12 |
| 2000 | 13 |
| 2001 | 6 |
| 2002 | 2 |
| 2003 | 8 |
| 2004 | 4 |
| 2005 | 7 |
| 2006 | 26 |
| 2007 | 20 |
| 2008 | 12 |
| 2009 | 10 |
| 2010 | 11 |
| 2011 | 18 |
| 2012 | 15 |
| 2013 | 7 |
| 2014 | 16 |
| 2015 | 11 |
| 2016 | 12 |
| 2017 | 15 |
| 2018 | 13 |
| 2019 | 4 |
| 2020 | 9 |
| 2021 | 5 |
| 2022 | 4 |
| 2023 | 6 |
| 2024 | 8 |
| 2025 | 5 |
| 2026 | 2 |
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.
Planning a device in DXY? 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? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 17, 2022 | Class II | Z-1497-2022 | Software design | The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up. |
| Jun 17, 2022 | Class II | Z-1496-2022 | Software design | The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up. |
| Jun 17, 2022 | Class II | Z-1495-2022 | Software design | There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers. |
| Sep 23, 2011 | Not classified | Z-0429-2012 | Pending | St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements.These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are… |
| Sep 23, 2011 | Not classified | Z-0430-2012 | Pending | St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements. These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are… |
| Oct 6, 2006 | Not classified | Z-0296-2007 | Other | St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and… |
| Oct 6, 2006 | Not classified | Z-0297-2007 | Other | St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and… |
| Oct 6, 2006 | Not classified | Z-0298-2007 | Other | St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and… |
| Jul 31, 2003 | Not classified | Z-0052-04 | Other | Under certain circumstances, pacemaker has a potential to deliver a short coupled pacing interval of approx. 300 msec (200ppm). It is also possible that a patient may experience (up to max of 12) shorter than anticipated pacing intervals. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DXY devicesDXY Implantable Pacemaker Pulse-Generator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXY
19in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXY
Too few DXY 510(k)s in any year since 2007 to give a median.
Recalls per year · DXY
4in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXY
810in 2025
MAUDE reports naming product code DXY, 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 | 0 | — | 0 | 2,407 |
| 2008 | 0 | — | 0 | 2,649 |
| 2009 | 0 | — | 6 | 3,750 |
| 2010 | 0 | — | 1 | 4,187 |
| 2011 | 0 | — | 2 | 6,050 |
| 2012 | 0 | — | 0 | 3,709 |
| 2013 | 0 | — | 0 | 2,682 |
| 2014 | 0 | — | 0 | 5,604 |
| 2015 | 0 | — | 0 | 1,022 |
| 2016 | 15 | — | 0 | 542 |
| 2017 | 51 | — | 4 | 1,047 |
| 2018 | 45 | — | 0 | 2,070 |
| 2019 | 19 | — | 0 | 1,799 |
| 2020 | 23 | — | 0 | 546 |
| 2021 | 20 | — | 0 | 560 |
| 2022 | 14 | — | 0 | 784 |
| 2023 | 19 | — | 0 | 922 |
| 2024 | 20 | — | 0 | 773 |
| 2025 | 19 | — | 0 | 810 |
| 2026 | 19 | — | 0 | — |
https://510kreport.com/device/P880086 · printed Nov 6, 2026
Cite this page
510(k) Report. “P880086: Accent, Identity, Verity, Victory and Zephyr Pacemakers.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P880086
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026