# Intuitive Surgical safety record

46 incident(s) on file for Intuitive Surgical, rolled up across its models and deployments (operated or manufactured). Retracted claims are excluded from this count but remain reachable at their own canonical URLs.

[Back to Intuitive Surgical](/companies/intuitive-surgical.md)

## Incidents (46)

- [Intuitive Surgical recalls da Vinci SP1098 instrument](/incidents/recall-2026-06-22-intuitive-surgical.md) (2026-06-22): Recall · severity: moderate · FDA · recall ordered
- [Intuitive Surgical recalls 8mm SureForm 30 Gray Reloads after patient death](/incidents/recall-2026-05-28-intuitive-surgical.md) (2026-05-28): Recall · severity: catastrophic · FDA · recall ordered
- [Sunnybrook study: robotic-assisted knee replacement associated with double the risk of major complications](/incidents/other-2026-04-01-intuitive-surgical.md) (2026-04-01): Other · severity: serious · none
- [da Vinci 8mm SureForm 30 Gray stapler reload recall after incomplete staple lines (1 death, 4 serious injuries)](/incidents/davinci-sureform-gray-reload-recall-death-2026.md) (2026-03-11): Recall · severity: critical · FDA · recall ordered · 1 fatality/fatalities
- [Intuitive recalls da Vinci 8mm SureForm 30 Gray Reloads (Class I) over incomplete staple lines](/incidents/davinci-sureform30-gray-reloads-incomplete-staple-recall-2026.md) (2026-03-11): Recall · severity: critical · FDA · recall ordered
- [FDA Class 2 recall: da Vinci 5 viewer display firmware issue causing loss of 3D surgical field](/incidents/recall-2026-02-18-intuitive-surgical.md) (2026-02-18): Recall · severity: serious · FDA · recall ordered
- [da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use](/incidents/davinci-instrument-arm-diagnostic-recall-2026.md) (2026-02-02): Recall · severity: serious · FDA · recall ordered
- [Intuitive Ion Endoluminal System recall: probe-bag sterile-seal issue (Z-1134-2026)](/incidents/intuitive-ion-recall-2026-z1134.md) (2026-01-28): Recall · severity: moderate · FDA · recall ordered
- [Intuitive Surgical da Vinci 5 receives FDA clearance for cardiac procedures](/incidents/regulatory-action-2026-01-26-intuitive-surgical.md) (2026-01-26): Regulatory action · severity: minor · FDA · other
- [Intuitive recalls da Vinci SP Access Port Kit over trays that can crack and breach sterility](/incidents/davinci-sp-access-port-tray-crack-sterility-recall-2026.md) (2025-12-15): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci S/Si Mega Needle Driver over broken or frayed grip cables](/incidents/davinci-mega-needle-driver-frayed-grip-cable-recall-2026.md) (2025-12-09): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci S/Si Permanent Cautery Hook over frayed or broken pitch cables](/incidents/davinci-permanent-cautery-hook-frayed-pitch-cable-recall-2026.md) (2025-12-09): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci X/Xi and da Vinci 5 software that left failed-diagnostic arms available for clinical use](/incidents/davinci-x-xi-failed-diagnostic-arms-software-recall-2026.md) (2025-11-07): Recall · severity: serious · FDA · recall ordered
- [da Vinci SP: patient experienced abdominal pain, bleeding, and wound infection (FDA MAUDE)](/incidents/davinci-sp-postop-bleeding-wound-infection-maude-2025.md) (2025-06-18): Injury · severity: serious · FDA (MAUDE)
- [da Vinci 5 console foot-pedal recall over a spring failure that can leave a pedal stuck pressed](/incidents/davinci5-foot-pedal-spring-recall-2025.md) (2025-02-26): Recall · severity: moderate · FDA · recall ordered
- [da Vinci endoscope: light left on burned the patient after resting on the thigh (FDA MAUDE)](/incidents/davinci-endoscope-light-thigh-burn-maude-2025.md) (2025-01-21): Injury · severity: serious · FDA (MAUDE)
- [Intuitive recalls da Vinci 8mm ProGrasp Forceps over frayed or broken grip cables](/incidents/davinci-prograsp-forceps-frayed-grip-cable-recall-2025.md) (2024-12-19): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci Monopolar Curved Scissors over frayed/broken grip cables causing loss of instrument control](/incidents/davinci-monopolar-curved-scissors-frayed-grip-cable-recall-2025.md) (2024-12-19): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci 8mm Large Needle Driver over frayed or broken grip cables](/incidents/davinci-large-needle-driver-frayed-grip-cable-recall-2025.md) (2024-12-19): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci 8mm Mega SutureCut Needle Driver over frayed or broken grip cables](/incidents/davinci-mega-suturecut-needle-driver-frayed-grip-cable-recall-2025.md) (2024-12-19): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci 8mm Horizon Small Clip Applier over frayed or broken grip cables](/incidents/davinci-horizon-small-clip-applier-frayed-grip-cable-recall-2025.md) (2024-12-19): Recall · severity: serious · FDA · recall ordered
- [Intuitive Ion Endoluminal System recall: instrument-cart-arm screw issue (Z-2720-2024)](/incidents/intuitive-ion-recall-2024-z2720.md) (2024-09-04): Recall · severity: moderate · FDA · recall ordered
- [Intuitive recalls da Vinci Single-Site Wristed Needle Driver over dislodging or breakage causing uncontrolled movement](/incidents/davinci-single-site-wristed-needle-driver-dislodge-recall-2024.md) (2023-10-06): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci Tip-Up Fenestrated Grasper over grip breakage that can drop steel fragments into patients](/incidents/davinci-tip-up-fenestrated-grasper-grip-breakage-recall-2023.md) (2023-06-12): Recall · severity: serious · FDA · recall ordered
- [da Vinci X/Xi recall: loose instrument carriage from an out-of-spec linear-rail component](/incidents/davinci-instrument-carriage-recall-2023.md) (2023-02-23): Recall · severity: moderate · FDA / Health Canada · recall ordered
- [da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments](/incidents/davinci-sureform-stapler-fragment-recall-2022.md) (2022-10-07): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci X/Xi systems over inadvertent energy delivery with Force bipolar instruments](/incidents/davinci-x-xi-force-bipolar-inadvertent-energy-recall-2023.md) (2022-09-20): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci X/Xi and S/Si Clip Appliers over unexpected motion from partial disengagement](/incidents/davinci-xi-clip-applier-unexpected-motion-recall-2022.md) (2022-07-01): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci X/Xi SureForm 45 staplers over tissue pushout that can cause critical bleeding](/incidents/davinci-xi-sureform45-tissue-pushout-bleeding-recall-2022.md) (2022-03-17): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci EndoWrist Vessel Sealer Extend instruments over risk of insufficient vessel seals](/incidents/davinci-vessel-sealer-extend-insufficient-seal-recall-2022.md) (2022-03-03): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci SynchroSeal instruments over risk of insufficient vessel seals](/incidents/davinci-synchroseal-insufficient-seal-recall-2022.md) (2022-03-03): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci Xi/X Conductive Cannula Reducer over metal tip that can dislodge inside patients](/incidents/davinci-conductive-cannula-reducer-dislodge-recall-2021.md) (2021-12-23): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls Ion Flexision 19G Biopsy Needle over a sheath tip that can separate from the shaft](/incidents/ion-flexision-biopsy-needle-sheath-tip-separation-recall-2022.md) (2021-08-06): Recall · severity: serious · FDA · recall ordered
- [Intuitive Ion Endoluminal System recalls (fully-articulating catheter and Flexison biopsy needle)](/incidents/intuitive-ion-recall-2020.md) (2020-12-02): Recall · severity: moderate · FDA · recall ordered
- [Intuitive recalls Ion Fully Articulating Catheter over a distal tip ring that can become dislodged](/incidents/ion-articulating-catheter-distal-tip-ring-dislodge-recall-2021.md) (2020-10-23): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls Ion Catheter Reprocessing Cover over disengagement that can retain cleaning chemicals](/incidents/ion-catheter-reprocessing-cover-chemical-retention-recall-2020.md) (2020-06-10): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci X and Xi systems over defective capacitors that can cause vision loss or system errors](/incidents/davinci-x-xi-defective-capacitor-vision-loss-recall-2020.md) (2019-07-26): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci 8mm Monopolar Curved Scissors over extension-tube cracks that can drop fragments into patients](/incidents/davinci-monopolar-scissors-extension-tube-crack-recall-2018.md) (2018-08-15): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci X systems over a high rate of ACJ board failure](/incidents/davinci-x-acj-board-failure-recall-2018.md) (2018-03-07): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci Xi EndoWrist Suction Irrigator over unexpected arm motion in specific software scenarios](/incidents/davinci-xi-suction-irrigator-unexpected-arm-motion-recall-2017.md) (2017-03-31): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci EndoWrist Stapler 45 over increased Stapler Firing Failed complaints](/incidents/davinci-endowrist-stapler45-firing-failed-recall-2016.md) (2016-07-14): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci 30-degree 8mm Endoscope over risk of patient harm from monopolar energy](/incidents/davinci-30deg-8mm-endoscope-monopolar-energy-recall-2016.md) (2015-11-23): Recall · severity: serious · FDA · recall ordered
- [Intuitive recalls da Vinci Fundus Grasper over jaws that can become stuck closed](/incidents/davinci-fundus-grasper-jaws-stuck-closed-recall-2015.md) (2015-08-08): Recall · severity: serious · FDA · recall ordered
- [FDA warning letter to Intuitive Surgical over late reporting of da Vinci corrections and adverse events](/incidents/intuitive-fda-warning-letter-2013.md) (2013-07-19): Regulatory action · severity: serious · FDA · other
- [da Vinci Hot Shears (monopolar curved scissors) Class I recall: insulation micro-cracks caused tissue burns](/incidents/davinci-hot-shears-burn-recall-2013.md) (2013-05-08): Recall · severity: critical · FDA · recall ordered
- [Intuitive recalls da Vinci 8mm Maryland Bipolar Forceps over a cautery plug insert that can dislodge](/incidents/davinci-maryland-bipolar-forceps-cautery-plug-dislodge-recall-2013.md) (2013-05-08): Recall · severity: serious · FDA · recall ordered

## Exposure

DEPLOY does not have exposure data (deployment-hours, miles driven, or rides given) on file for Intuitive Surgical's 7 recorded deployment(s). No incident count above can be turned into a defensible rate without it. NHTSA's SGO dataset itself does not publish exposure denominators; there is no standardized, regulator-verified nationwide source for AV fleet mileage or ride counts today.

## A note on NHTSA's crash-reporting data

Many of the incidents below are drawn from NHTSA's Standing General Order (SGO) 2021-01 crash-reporting program, which requires manufacturers and operators of automated driving systems (ADS) and advanced driver-assistance systems (ADAS) to report qualifying crashes. It is the only nationwide, cross-operator crash dataset that exists for this industry, and it is also, by NHTSA's own design and Consumer Reports' public assessment, an imperfect one.

Reporting companies may redact narrative fields as confidential business information (CBI). In practice this means narrative completeness is uneven across manufacturers in the underlying dataset: some incident reports read as full prose descriptions of what happened, others are replaced with boilerplate redacted text. This is a property of the source data, not of DEPLOY's editorial process; DEPLOY publishes what the filing discloses and states plainly when a fuller account is not publicly available.

The SGO dataset also does not publish exposure denominators (miles driven, hours operated, rides given) alongside crash counts, so a raw incident count cannot be turned into a rate without an independently sourced denominator. See "Exposure" below for what DEPLOY does and does not have on file for this company.

- [NHTSA: Standing General Order on Crash Reporting](https://www.nhtsa.gov/laws-regulations/standing-general-order-crash-reporting)
- [Consumer Reports: comments to NHTSA on incident reporting for ADS and Level 2 ADAS](https://advocacy.consumerreports.org/research/consumer-reports-comments-to-nhtsa-on-incident-reporting-for-automated-driving-systems-and-level-2-adas/)
- [Consumer Reports: statement on crash-reporting underreporting](https://advocacy.consumerreports.org/press_release/transportation-department-keeps-in-place-vital-car-crash-reporting-program-but-misses-chance-to-address-underreporting-consumer-reports-statement/)

## Common questions

**What is Intuitive Surgical's safety record?**

DEPLOY has 46 incidents on file for Intuitive Surgical, drawn from NHTSA's Standing General Order crash-reporting program and press coverage. Each incident below is individually sourced and dated; see the incident list for details.

**Is Intuitive Surgical safer than a human driver?**

DEPLOY does not have exposure data (miles driven or hours operated) on file for Intuitive Surgical, so no per-mile or per-hour safety rate can be computed from this registry today. This is a documented industry-wide data gap, not unique to DEPLOY: NHTSA's own SGO dataset does not publish exposure denominators alongside crash counts. Any rate comparison you see elsewhere may rely on a company's self-published mileage figures, which are not independently audited.

**Has Intuitive Surgical been involved in a fatal incident?**

Yes. DEPLOY has 1 incident on file for Intuitive Surgical recording at least one fatality. See the incident list below for the sourced details of each.

**Does DEPLOY redact or omit crash details for Intuitive Surgical?**

No. DEPLOY does not redact incident narratives. Where a source narrative is itself incomplete (for example, a NHTSA SGO filing redacted as confidential business information), DEPLOY states that plainly rather than filling the gap. See "A note on NHTSA's crash-reporting data" below.


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