PMA · Approved
Recalled · Class I · 2022Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Approved on Jan 31, 2017 through premarket approval, which rests on the device’s own clinical evidence after a 769-day review. It has a Class I recall. It has been recalled 5 times, including 2 Class I recalls.
- Decided
- Jan 31, 2017
- Review
- 769 days
- Class
- Class III
- Product code
- LWP
- Recalls
- 5 (2 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P140033 has 100 supplements since 2017: 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 |
|---|---|
| 2017 | 17 |
| 2018 | 23 |
| 2019 | 8 |
| 2020 | 15 |
| 2021 | 6 |
| 2022 | 6 |
| 2023 | 6 |
| 2024 | 11 |
| 2025 | 6 |
| 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.
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, 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. |
| Mar 15, 2021 | Class I | Z-1530-2021 | Process control | Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and… |
| Mar 15, 2021 | Class I | Z-1531-2021 | Process control | Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LWP devicesLWP Implantable Pulse Generator, Pacemaker (Non-Crt): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LWP
46in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LWP
Too few LWP 510(k)s in any year since 2007 to give a median.
Recalls per year · LWP
21in 2025
Class I (26 since 2007) Class II/III not classified
Adverse event reports per year · LWP
11,931in 2025
MAUDE reports naming product code LWP, 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 | 58 | — | 7 | 49 |
| 2008 | 87 | — | 2 | 496 |
| 2009 | 78 | — | 8 | 805 |
| 2010 | 66 | — | 7 | 678 |
| 2011 | 91 | — | 0 | 684 |
| 2012 | 123 | — | 0 | 1,087 |
| 2013 | 116 | — | 2 | 5,164 |
| 2014 | 126 | — | 2 | 9,400 |
| 2015 | 97 | — | 2 | 9,422 |
| 2016 | 97 | — | 1 | 12,354 |
| 2017 | 116 | — | 21 | 11,643 |
| 2018 | 97 | — | 0 | 14,936 |
| 2019 | 88 | — | 0 | 9,627 |
| 2020 | 90 | — | 0 | 8,989 |
| 2021 | 70 | — | 0 | 9,374 |
| 2022 | 65 | — | 0 | 14,286 |
| 2023 | 54 | — | 0 | 12,633 |
| 2024 | 58 | — | 4 (4) | 10,495 |
| 2025 | 46 | — | 21 (21) | 11,931 |
| 2026 | 40 | — | 1 (1) | — |
https://510kreport.com/device/P140033 · printed Nov 6, 2026
Cite this page
510(k) Report. “P140033: Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P140033
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026