CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)

K231207

Biosense Webster, Inc. · cleared 2023-09-07 · product code DQK · Cardiovascular

Premarket evidence — what FDA accepted

Device typesimd
source quote (p.5)
“The CARTOTM 3 EP Navigation System V8.0, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze navigation catheter's location and intracardiac ECG signals and use this information to display 3D anatomical and electroanatomical maps of the human heart.”
Algorithmmachine learning locked algorithm; Deep Learning (DL) algorithm
source quote (p.7)
“The Complex Signals Identification (CSI) module is a machine learning locked algorithm that automatically tags fractionated IC ECG signals. The CARTOSOUNDTM FAM Module incorporates a Deep Learning (DL) algorithm.”
Adaptive (vs locked)No
source quote (p.7)
“The Complex Signals Identification (CSI) module is a machine learning locked algorithm that automatically tags fractionated IC ECG signals.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (4)

Retrospective clinical

sample size not stated

endpoints: validate the clinical functionality and quality of new introduced modules

Bench

sample size not stated

endpoints: validate that CARTOTM 3 System V8.0 User Interface is safe and effective for use.

Bench

sample size not stated

endpoints: evaluate the CARTOTM 3 System V8.0 functionality under simulated clinical workflow and conditions.

Retrospective clinical

sample size not stated

endpoints: evaluating the safety and acute effectiveness of Paroxysmal Atrial Fibrillation ablation with a zero/low fluoroscopy workflow; primary safety and secondary acute effectiveness endpoints were met in the REAL AF Registry population; comparable cumulative incidences of the secondary safety endpoint between the zero/low fluoroscopy group and the conventional fluoroscopy group

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

28
recalls in product code, 24mo
423
MAUDE reports in code, 12mo
-1%
vs code's own 3-yr baseline
3
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252972 (decision 2026-02-20) from Biosense Webster, Inc. for a matching device line ("CARTO™ 3 EP Navigation System V8.4") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252972

  • recall_reason_pattern

    Software/algorithm-related recall in product code DQK (Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom, initiated 2025-09-16): "Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97686

  • recall_reason_pattern

    Software/algorithm-related recall in product code DQK (Boston Scientific Corporation, initiated 2024-09-05): "Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95331

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Biosense Webster (israel), Ltd.) — same firm and product code, not necessarily this device · initiated 2020-06-22

    Software defect may result in disapperance of tag sites during recalculation and lead to additional ablation sites. This may lead to prolongation of the procedure and, in extremely rare circumstances, cardiac perforation.

    recall event 85910 (openFDA)

  • Recalling firm matches this device's applicant (Biosense Webster, Inc.) — same firm and product code, not necessarily this device · initiated 2016-08-15

    Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as described in the Instructions for Use (IFU).

    recall event 75012 (openFDA)

  • Recalling firm matches this device's applicant (Biosense Webster, Inc.) — same firm and product code, not necessarily this device · initiated 2015-09-10

    Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added.

    recall event 72167 (openFDA)

  • Recalling firm matches this device's applicant (Biosense Webster, Inc.) — same firm and product code, not necessarily this device · initiated 2014-02-12

    Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2.2 and V3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particular procedural configurations only. If the table rotation is not returned to zero point, there is a misalignment between the Carto 3 System map display and the fluoroscopic capture.

    recall event 67505 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K231207