FDA product code · Cardiovascular
Device, Removal, Pacemaker Electrode, Percutaneous
1 FDA decision since 1997. No recall names this code.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MFA at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · MFA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MFA
Too few MFA 510(k)s in any year since 2007 to give a median.
Recalls per year · MFA
No recall names MFA since 2007.
Adverse event reports per year · MFA
67in 2025
MAUDE reports naming product code MFA, 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 | 7 |
| 2008 | 0 | — | 0 | 25 |
| 2009 | 4 | — | 0 | 46 |
| 2010 | 5 | — | 0 | 79 |
| 2011 | 7 | — | 0 | 80 |
| 2012 | 13 | — | 0 | 134 |
| 2013 | 2 | — | 0 | 142 |
| 2014 | 4 | — | 0 | 121 |
| 2015 | 2 | — | 0 | 73 |
| 2016 | 2 | — | 0 | 91 |
| 2017 | 5 | — | 0 | 96 |
| 2018 | 6 | — | 0 | 77 |
| 2019 | 3 | — | 0 | 66 |
| 2020 | 1 | — | 0 | 77 |
| 2021 | 1 | — | 0 | 83 |
| 2022 | 0 | — | 0 | 60 |
| 2023 | 1 | — | 0 | 55 |
| 2024 | 1 | — | 0 | 70 |
| 2025 | 1 | — | 0 | 67 |
| 2026 | 0 | — | 0 | — |
Planning a device in MFA? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report