510(k) · Cleared
Recalled · Class I · 2025WATCHMAN TruSeal Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · DQY Catheter, Percutaneous
Cleared on Jul 20, 2018 as substantially equivalent to K083214 (Aga Medical Corp., 2009) after a 109-day review. Its family tree reaches back 8 generations to 1989. 3 of the 43 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 5 times, including 5 Class I recalls.
- Decided
- Jul 20, 2018
- Review
- 109 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 5 (5 Class I)
- Predicates
- 1
Its longest line of descent runs back 8 generations to K893658 (1989). 40 ancestors in all, the oldest K770977 (1977). 2 later devices descend from it, 1 citing it directly. 3 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 7 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 6 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 5 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 4 generations backK032312 Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003
- 3 generations backK033989 Medtronic Selectsite Deflectable Catheter System, Models C304-S59…Medtronic Inc. Cardiac Rhythm Management · 2004
- 2 generations backK072313 Amplatzer Torqvue Delivery SystemAga Medical Corp. · 2007 · Recalled
- 1 generation backK083214 Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models…Aga Medical Corp. · 2009
- This deviceK180864 WATCHMAN TruSeal Access SystemBoston Scientific · 2018
- Descendant · cites it directly · 1 of its ownK212228 WATCHMAN FXD Curve Access SystemBoston Scientific Corporation · 2021 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK240018 WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation · 2024 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −7 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −6 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −5 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −4 | K032312 | Attain 6226DEF Deflectable Catheter Delivery System | Medtronic Vascular | 2003 | — |
| −3 | K033989 | Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 | Medtronic Inc. Cardiac Rhythm Management | 2004 | — |
| −2 | K072313 | Amplatzer Torqvue Delivery System | Aga Medical Corp. | 2007 | 1 |
| −1 | K083214 | Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100… | Aga Medical Corp. | 2009 | — |
| 0 (this device) | K180864 | WATCHMAN TruSeal Access System | Boston Scientific | 2018 | — |
| +1 | K212228 | WATCHMAN FXD Curve Access System | Boston Scientific Corporation | 2021 | Class I |
| +2 | K240018 | WATCHMAN TruSteer Access System (M635TU90050) | Boston Scientific Corporation | 2024 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 1 |
| 2024 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083214 | Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100…Summary page 4…ode DQY Classification Class II, 21 CFR Part 870.1250 Primary Predicate Amplatzer® TorqVue® Device 45°x45° Delivery K083214 12 May 2009 Sheath Reference WATCHMAN® Access… | 2009 |
| † | P130013 | Watchman Left Atrial Appendage (Laa) Closure Technology | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212228 | WATCHMAN FXD Curve Access System Class I | 2021 | 1 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2025 | Class I | Z-2426-2025 | Under Investigation by firm | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures… |
| Jul 29, 2025 | Class I | Z-2431-2025 | Under Investigation by firm | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures… |
| Jul 29, 2025 | Class I | Z-2432-2025 | Under Investigation by firm | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures… |
| Jul 29, 2025 | Class I | Z-2428-2025 | Under Investigation by firm | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures… |
| Jul 29, 2025 | Class I | Z-2427-2025 | Under Investigation by firm | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures… |
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.
- K212228WATCHMAN FXD Curve Access SystemBoston Scientific Corporation · 2021 · Cites it directly · ◆ in the 2021 descendants bar of FIG. 13 Class I recalls
- K240018WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation · 2024 · 2 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 6 of the 40 ancestors have a recall of any class.
- Of its descendants, K212228 (Boston Scientific Corporation, 2021) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K083214.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The WATCHMAN™ TruSeal™ Access System is intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180864 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180864: WATCHMAN TruSeal Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180864
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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