510(k) · Cleared
Recalled · 2011Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosense Webster, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Aug 31, 2000 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 59 devices in its family, counting itself, has a Class I recall. 58 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 31, 2000
- Review
- 30 days
- Class
- Class II
- Product code
- DRF
- Recalls
- 2
- Predicates
- 0
58 later devices descend from it, 6 citing it directly. 1 of the 59 devices in this family, counting this one, has a Class I recall.
- This deviceK002333 Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model…Biosense Webster, Inc. · 2000
- Descendant · cites it directly · 39 of its ownK050217 Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing)…Biosense Webster, Inc. · 2005
- Descendant · 2 generations on · 34 of its ownK120425 Pentaray Nav High-Density Mapping CatheterBiosense Webster, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 21 of its ownK172393 Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018
- Descendant · 4 generations on · 17 of its ownK202066 EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor…Abbott Medical · 2020
- Descendant · 5 generations on · 13 of its ownK212061 EnSite X EP SystemAbbott · 2021
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K241224 Medline ReNewal Reprocessed Biosense Webster…6 generations on · 2024
Most influential descendants
Showing 5 of 58 · See all- K050217Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM Electrode…Biosense Webster, Inc. · 2005 · cites it directly39descendants
- K120425Pentaray Nav High-Density Mapping CatheterBiosense Webster, Inc. · 2012 · 2 generations on34descendants
- K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018 · 3 generations on21descendants
- K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical · 2020 · 4 generations on17descendants
- K212061EnSite X EP SystemAbbott · 2021 · 5 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002333 | Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220 | Biosense Webster, Inc. | 2000 | — |
| +1 | K050217 | Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM… | Biosense Webster, Inc. | 2005 | — |
| +2 | K120425 | Pentaray Nav High-Density Mapping Catheter | Biosense Webster, Inc. | 2012 | 5 |
| +3 | K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | St. Jude Medical, Inc. | 2018 | — |
| +4 | K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled… | Abbott Medical | 2020 | — |
| +5 | K212061 | EnSite X EP System | Abbott | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 5 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 1 |
| 2025 | 6 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), 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 DRF device
- #1 K252794 Vision-MR™ Diagnostic Catheterscore 13.6 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (58)
See all 586 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050217 | Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM Electrode… | 2005 | 39 |
| K031161 | Variable Lasso 2515 Circular Mapping Catheter | 2003 | 9 |
| K093376 | Lasso Nav Catheter | 2010 | 5 |
| K012708 | Electrophysiology Catheter | 2002 | 5 |
| K193632 | LassoStar Circular Mapping Catheter | 2020 | 1 |
| K082023 | Reprocessed Electrophysiology Catheters | 2008 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2011 | Not classified | Z-2666-2011 | Pending | The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System. |
| May 23, 2011 | Not classified | Z-2667-2011 | Pending | The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System. |
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 · 6 generations on · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K050217 (Biosense Webster, Inc., 2005) has gone furthest, with 39 descendants of its own.
How does its category compare?
All DRF devicesDRF Catheter, Electrode Recording, Or Probe, Electrode Recording: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRF
45in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRF
508in 2025
MAUDE reports naming product code DRF, 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 | 2 | — | 2 | 120 |
| 2008 | 2 | — | 4 | 176 |
| 2009 | 7 | 243 | 0 | 122 |
| 2010 | 5 | 65 | 0 | 130 |
| 2011 | 3 | 190 | 6 | 245 |
| 2012 | 1 | — | 0 | 402 |
| 2013 | 2 | — | 0 | 310 |
| 2014 | 1 | — | 2 | 349 |
| 2015 | 3 | 29 | 1 | 327 |
| 2016 | 8 | 175 | 0 | 383 |
| 2017 | 7 | — | 0 | 458 |
| 2018 | 1 | — | 0 | 723 |
| 2019 | 10 | 163 | 0 | 669 |
| 2020 | 4 | — | 0 | 651 |
| 2021 | 12 | 124 | 0 | 625 |
| 2022 | 8 | 283 | 0 | 613 |
| 2023 | 5 | 45 | 0 | 685 |
| 2024 | 4 | — | 0 | 623 |
| 2025 | 3 | — | 0 | 508 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K002333 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002333: Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002333
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026