PMA · Approved
Recalled · Class III · 2019Arzco Transesophageal Cardiac Stimulator Model 7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardio Command · LPA System, Esophageal Pacing
Approved on Dec 30, 1986 through premarket approval, which rests on the device’s own clinical evidence after a 288-day review. It has been recalled 3 times.
- Decided
- Dec 30, 1986
- Review
- 288 days
- Class
- Class III
- Product code
- LPA
- Recalls
- 3
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P860008 has 17 supplements since 1988: 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 |
|---|---|
| 1988 | 4 |
| 1989 | 2 |
| 1991 | 2 |
| 1992 | 1 |
| 1998 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2009 | 1 |
| 2012 | 3 |
| 2017 | 1 |
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 LPA? 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 |
|---|---|---|---|---|
| May 10, 2019 | Class III | Z-1773-2019 | Process control | Possible corrosion of the battery contact(s). |
| Oct 25, 2010 | Not classified | Z-0071-2012 | Nonconforming Material/Component | CardioCommand, Inc. is recalling their TAPSCOPE 550 esophageal pacing/recording catheters because there maybe electrical discontinuity, which can result in the inability to reliably pace and/or record ECG. |
| Oct 25, 2010 | Not classified | Z-0072-2012 | Nonconforming Material/Component | CardioCommand, Inc. is recalling their TAPSCOPE 550 esophageal pacing/recording catheters because there maybe electrical discontinuity, which can result in the inability to reliably pace and/or record ECG. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LPA devicesLPA System, Esophageal Pacing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPA
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · LPA
Too few LPA 510(k)s in any year since 2007 to give a median.
Recalls per year · LPA
2in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPA
No MAUDE report names LPA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 2 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 3 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P860008 · printed Nov 6, 2026
Cite this page
510(k) Report. “P860008: Arzco Transesophageal Cardiac Stimulator Model 7.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P860008
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026