DEPLOYDatabase

Company

Intuitive Surgical

Dominant surgical-robotics maker (NASDAQ: ISRG; founded 1995, Sunnyvale CA) of the da Vinci teleoperated surgical robots and the Ion robotic bronchoscopy…

Track Intuitive Surgical
Founded
1995
HQ
Sunnyvale, California, USA
Status
public (NASDAQ: ISRG)

The verified answer

As of Aug 2026, DEPLOY verifies Intuitive Surgical: 2 models, 3 deployments across 3 regions, 56 active incidents. 10 sources back the record.

Regulatory status4 FDA 510(k) clearances11 FDA recalls1 FDA warning letter

Intuitive Surgical holds 4 FDA 510(k) clearances and has 11 FDA recalls and 1 FDA warning letter on record, per the DEPLOY registry.

See all 16 filings
PublicNASDAQ: ISRG

CategorySurgical robots

Models

2

Deployments

3

Patents

6

Overview

Dominant surgical-robotics maker (NASDAQ: ISRG; founded 1995, Sunnyvale CA) of the da Vinci teleoperated surgical robots and the Ion robotic bronchoscopy system; 11,000+ da Vinci installed worldwide.

Verified record

Verified deployments
3 deployments on file
Active incidents
56 incidents on file

Key facts

Installed base

11,395 da Vinci (1,464 da Vinci 5) + 1,041 Ion (SEC 10-Q, Q1 2026).

Gating events

da Vinci 5 FDA-cleared Mar 14 2024; Ion FDA-cleared Feb 2019.

Stock listing

NASDAQ: ISRG

Market position

Dominant surgical-robotics maker

da Vinci product type

Teleoperated surgical robot

Ion product type

Robotic bronchoscopy system

Hero image candidate

upload.wikimedia.org (source: Wikimedia Commons, license: CC BY-SA 4.0)

Data & sources

Company filings

2

Press releases

1

News coverage

1

Patent documents

6

10 sources backing this record.View all →

Models (2)

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Current platform

Ion Endoluminal System

Intuitive Surgical's Ion Endoluminal System is a robotic-assisted bronchoscopy platform for minimally invasive biopsy of peripheral lung nodules. It uses an ultra-thin, shape-sensing maneuverable catheter with PlanPoint CT-based airway planning to reach lesions deep in the peripheral lung. FDA 510(k) cleared in February 2019 and commercially deployed across US hospitals, with subsequent AI and advanced-imaging integration clearances.

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Current platform

da Vinci (and Ion)

Intuitive Surgical (NASDAQ: ISRG; founded 1995, Sunnyvale, California) is the dominant incumbent and verified gold standard of surgical robotics. Its da Vinci platform spans the multi-port X and Xi systems, the SP single-port system, and the fifth-generation da Vinci 5, which the FDA cleared via 510(k) on March 14, 2024 with a headline Force Feedback sensing feature, alongside the Ion endoluminal robotic bronchoscopy system cleared in February 2019. As of its SEC Form 10-Q for the quarter ended March 31, 2026, the verified installed base was 11,395 da Vinci systems, up 12 percent year over year and including 1,464 da Vinci 5 units, plus 1,041 Ion systems, up 22 percent, with worldwide procedures growing about 17 percent. Surgical robotics sits in the registry as a deliberate axis-extension: physical AI operating in the medical regulatory regime, where FDA clearance is the verified gating event for maturity, and Intuitive clears it across multiple platforms and generations, placing it at production maturity. On AI substance, da Vinci is a master-slave teleoperated system with shipped analytics-grade AI such as Case Insights and machine-vision interface features, and Force Feedback is a shipped sensing feature rather than autonomy; autonomous suturing and tissue manipulation via vision-language models are research demonstrations on da Vinci hardware, not shipped features, and the 4,000-mile telesurgery demonstration is investigational. The widely cited 43-percent-less-force figure is preclinical and marketing-sourced rather than an outcomes-verified clinical result.

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Intuitive Surgical on the deployment map

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3 verified deployments across 3 regions, newest verified Jan 2007. Explore where Intuitive Surgical's robots are operating, by place and type.

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Relationships

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Explainers

Plain-language answers to the questions people ask about Intuitive Surgical, from DEPLOY’s explainer library. Each is written in the language of the question and cross-checked against this registry.

What is a surgical robot?
A surgical robot is a computer-assisted operative platform that places robotic arms, instruments, and visualization systems between the surgeon and the patient. The 2026 commercial cohort includes Intuitive Surgical (da Vinci + Ion; 11,395 + 1,041 systems installed per SEC 10-Q), Medtronic Hugo, CMR Surgical Versius, Asensus/Karl Storz Senhance, Stereotaxis Genesis, Distalmotion Dexter, Moon Surgical Maestro (ScoPilot is the cohort's genuine shipped surgical AI standout, FDA-cleared with a Predetermined Change Control Plan), and Brain Navi NaoTrac (autonomous registration, not tissue manipulation). J&J Ottava (De Novo submission January 2026) and Vicarious Surgical V1 remain pre-market research per DEPLOY's FDA-clearance-as-gating-event framework. The autonomy spectrum runs from teleoperated baseline through analytics AI to narrow autonomous registration; tissue-manipulation autonomy remains research demos on production hardware, not shipped product.Read the full explainer →
What is Intuitive Surgical and the da Vinci surgical robot?
Intuitive Surgical is the verified-at-scale anchor of the surgical robotics cohort. Per SEC 10-Q registry source-of-truth, installed base is 11,395 da Vinci systems + 1,041 Ion systems; the installed base dwarfs combined competitor installed base. da Vinci 5 was FDA-cleared March 2024 as the current product generation; Ion is a separate robotic-bronchoscopy product line. Architecture is teleoperated baseline with shipped analytics AI; autonomous suturing work on da Vinci hardware is research demos, not shipped product. Maturity: production. Per DEPLOY's framework, da Vinci is the gold standard verified deployment all other surgical entrants are measured against.Read the full explainer →
How does DEPLOY track the 2026 da Vinci SureForm gray-reload Class I recall?
DEPLOY tracks the 2026 da Vinci SureForm gray-reload Class I recall at primary-source-anchored FDA-recall-database verification depth as the surgical cohort's most severe verified incident. The substrate: 8mm SureForm 30 Gray reloads (2mm staples for extra-thin tissue) produced incomplete staple lines on blood vessels despite a 'completed' fire indication; customer letter / quarantine March 11, 2026; FDA classified Class I (reported May 2026); 1 death + 4 serious injuries (bleeding). Blue/white reloads UNAFFECTED at canonical within-product-family verification scope distinction. The framework reads the incident at four substrate layers simultaneously: incident-recall actuarial depth per Phase 3 Dim 1 (severity=critical at primary-source-anchored verification; cohort's most severe); within-entity verification scope at sub-product-line granularity (gray vs blue/white reload distinction is the within-da-Vinci feature-level verification posture distinct); regulatory clearance per jurisdiction at Dim 4 (FDA Class I primary-government-record sub-tier verification); year-discipline framework distinguishing the 2026 gray-reload recall from the 2022 SureForm fragment recall (Z-0340-2023; Class II; October 7, 2022) at year-class-failure-mode granularity. Cap-flag honest-absence at exact recall Z-number + unit count (not captured from primary FDA pages). Root cause stated 'still under investigation' at primary-source-anchored verification depth.Read the full explainer →
How does DEPLOY track incident outcome_class and deployment exposure_hours at actuarial depth?
DEPLOY tracks Phase 3 Dim 1 actuarial substrate at primary-source-anchored verification depth across two structurally-distinct axes simultaneously: incident numerator (outcome_class at 67 rows across 61 incidents; multi-class where evidenced; distribution skewed regulatory_action:34 + property_damage:18 + bodily_injury:7 + no_outcome:4 + financial_loss:2 + fatality:1 + near_miss:1) and deployment denominator (exposure_hours at canonical 128-nulls honest-absence; Agent A documented under-population over fabrication). The 128-nulls is the canonical worked example for 'honest absence at full-population scale beats partial fabrication.' Scalar selectivity tight per *_basis verified-vs-claimed discipline: 1 USD figure at primary-source-anchored verification depth (MQ-9 Reaper $32M reported_press gt_10m); 3 fatality_count rows; 5 bodily_injury_severity rows; 4 loss_cost_class rows; most NULL at honest-absence cap-flag. Cap-flag-as-trust-signal operates recursively at three substantive layers simultaneously: 128-null exposure_hours denominator (full-population honest-absence) + scalar selectivity at 1-of-61 USD verified ratio (extreme primary-source-anchored selectivity) + outcome distribution skew (no_outcome:4 documented as substantive editorial state, not as substrate-completeness gap). The framework operates at honesty-as-strength rather than coverage-as-strength: under-population at primary-source-anchored verification depth beats fabrication at marketing-aggregation depth. Rover's 5-commit Dim 1 surface work landed across all four axes (callable MCP tool + structured JSON-LD + human-facing /incidents page + REST aggregated endpoint); substrate is fully live and queryable.Read the full explainer →
How does DEPLOY distinguish da Vinci safety events at year-class-failure-mode-product-variant granularity?
DEPLOY tracks within-da-Vinci-product-family safety events at year-class-failure-mode-product-variant granularity per Agent A's surgical incidents substrate. The three canonical worked examples span distinct product lines + distinct years + distinct classes + distinct failure modes simultaneously: 2013 EndoWrist Hot Shears Class I recall (May 8, 2013 Urgent Medical Device Notification; '-09'/'-10' versions; insulation micro-cracks near distal shaft after cleaning/sterilization create monopolar energy arc path; burn tissue outside surgical field; 134 tip-cover complaints + 82 MDRs Jan 2010-Dec 2011; remediated via instrument version supersession; load-bearing historical da Vinci safety event); 2022 SureForm fragment Class II recall (Z-0340-2023; October 7, 2022; da Vinci Xi 8mm SureForm 30 curved-tip staplers and reloads; intraoperative device-fragment generation; potential staple deployment failure); 2026 SureForm gray-reload Class I recall (March 11, 2026 customer letter + Class I reported May 2026; 8mm SureForm 30 Gray reloads; incomplete staple lines on blood vessels; 1 death + 4 serious injuries; cohort's most severe per the 2026 gray-reload framework-in-action narrative). Plus adjacent 2013 FDA Warning Letter regulatory_action (July 19, 2013; distinct from May 2013 device recall; reporting-compliance regulatory action; serious severity; cap-flag honest-absence at primary FDA letter direct retrieval). Aggregator coverage frequently collapses 'da Vinci recalls' across years; the framework distinguishes them structurally at four substrate axes simultaneously (year + class + failure mode + product variant) per verified-vs-claimed at within-entity granularity methodology pillar.Read the full explainer →

Current leadership (3)

Founders (3)

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Board (3)

Former / Previously (5)

Safety record

47 recalls and 9 incidents on record (1 catastrophic, 4 critical, 39 serious, 9 moderate, 2 minor). Most recent: Jun 2026.

catastrophic
1
critical
4
serious
39
moderate
9
minor
2
Severity not classified
1
recall
47
regulatory action
4
other
2
injury
2
fatality
1

Most recent: Jun 2026

Only active incidents are counted. Retracted incidents are excluded from this summary but remain reachable at their canonical URLs.

Full safety record: incidents, sourcing, and exposure data →

Incidents affecting Intuitive Surgical (56)

Includes incidents linked directly to this company, to its models, or to deployments of its models or under its operation. Retracted incidents are excluded from this view but remain reachable at their canonical URLs.

Operator customers (1)

Recent coverage

Intuitive Surgical in third-party press

This Surgical Robot Could Transform the Operating Room

Aug 2, 2026

Da Vinci 5 Cleared for Cardiac Procedures

Jul 26, 2026

SRS 2026 recap: The biggest surgical robot stories of the last week

Jul 23, 2026

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