510(k) · Cleared
Recalled · 2005Constellation Multiple Electrode Pacing and Recording System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · MTD Catheter, Intracardiac Mapping, High-Density Array
Cleared on Mar 11, 1999 after a 182-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 57 devices in its family, counting itself, has a Class I recall. 56 later devices descend from it. It has been recalled once.
- Decided
- Mar 11, 1999
- Review
- 182 days
- Class
- Class II
- Product code
- MTD
- Recalls
- 1
- Predicates
- 0
56 later devices descend from it, 3 citing it directly. 1 of the 57 devices in this family, counting this one, has a Class I recall.
- This deviceK983171 Constellation Multiple Electrode Pacing and Recording SystemBoston Scientific Corp · 1999
- Descendant · cites it directly · 55 of its ownK992777 Constellation Catheters, Model 8039Boston Scientific Corp · 1999 · Recalled
- Descendant · cites it directly · 54 of its ownK021232 Constellation Catheters, Model 8031MBoston Scientific Corp · 2002 · Recalled
- Descendant · 2 generations on · 39 of its ownK050217 Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing)…Biosense Webster, Inc. · 2005
- Descendant · 3 generations on · 34 of its ownK120425 Pentaray Nav High-Density Mapping CatheterBiosense Webster, Inc. · 2012 · Recalled
- Descendant · 4 generations on · 21 of its ownK172393 Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K241224 Medline ReNewal Reprocessed Biosense Webster…7 generations on · 2024
Most influential descendants
Showing 5 of 56 · See all- K992777Constellation Catheters, Model 8039Boston Scientific Corp · 1999 · cites it directly55descendants
- K021232Constellation Catheters, Model 8031MBoston Scientific Corp · 2002 · cites it directly54descendants
- K050217Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM Electrode…Biosense Webster, Inc. · 2005 · 2 generations on39descendants
- K120425Pentaray Nav High-Density Mapping CatheterBiosense Webster, Inc. · 2012 · 3 generations on34descendants
- K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983171 | Constellation Multiple Electrode Pacing and Recording System | Boston Scientific Corp | 1999 | — |
| +1 | K992777 | Constellation Catheters, Model 8039 | Boston Scientific Corp | 1999 | 1 |
| +1 | K021232 | Constellation Catheters, Model 8031M | Boston Scientific Corp | 2002 | 1 |
| +2 | K050217 | Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM… | Biosense Webster, Inc. | 2005 | — |
| +3 | K120425 | Pentaray Nav High-Density Mapping Catheter | Biosense Webster, Inc. | 2012 | 5 |
| +4 | K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | St. Jude Medical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 1 |
| 2025 | 7 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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.
Top candidate predicates for a new MTD device
- #1 K231312 PENTARAY® NAV ECO High Density Mapping…score 16.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (56)
See all 563 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 14, 2005 | Not classified | Z-0639-05 | Other | The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline…Surgical Instrument Service and Savings Inc.(Dba Medline Ren · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K992777 (Boston Scientific Corp, 1999) has gone furthest, with 55 descendants of its own.
How does its category compare?
All MTD devicesMTD Catheter, Intracardiac Mapping, High-Density Array: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MTD
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MTD
66in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MTD
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MTD
385in 2025
MAUDE reports naming product code MTD, 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 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 19 |
| 2011 | 0 | — | 0 | 14 |
| 2012 | 2 | — | 0 | 17 |
| 2013 | 2 | — | 0 | 30 |
| 2014 | 2 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 36 |
| 2016 | 1 | — | 0 | 35 |
| 2017 | 2 | — | 2 | 38 |
| 2018 | 1 | — | 0 | 49 |
| 2019 | 0 | — | 0 | 77 |
| 2020 | 4 | 169 | 0 | 87 |
| 2021 | 1 | — | 0 | 99 |
| 2022 | 2 | — | 0 | 145 |
| 2023 | 3 | 66 | 0 | 184 |
| 2024 | 2 | — | 0 | 378 |
| 2025 | 0 | — | 0 | 385 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
For use in right atrial electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Constellation Multiple Electrode Mapping Catheter may also be used to deliver externally generated pacing stimuli.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983171: Constellation Multiple Electrode Pacing and Recording System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983171
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026