Safety record
Intuitive Surgical safety record
46 incidents on file for Intuitive Surgical, rolled up across its models and deployments (operated or manufactured). Each entry below is individually sourced and dated; retracted claims are excluded from this count but remain reachable at their own canonical URLs.
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Incidents
Recall · severity: moderate · FDA · recall ordered
Recall · severity: catastrophic · FDA · recall ordered
Other · severity: serious · none
Recall · severity: critical · FDA · recall ordered · 1 fatality/fatalities
- Intuitive recalls da Vinci 8mm SureForm 30 Gray Reloads (Class I) over incomplete staple lines2026-03-11
Recall · severity: critical · FDA · recall ordered
- FDA Class 2 recall: da Vinci 5 viewer display firmware issue causing loss of 3D surgical field2026-02-18
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
Recall · severity: moderate · FDA · recall ordered
Regulatory action · severity: minor · FDA · other
- Intuitive recalls da Vinci SP Access Port Kit over trays that can crack and breach sterility2025-12-15
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
- da Vinci SP: patient experienced abdominal pain, bleeding, and wound infection (FDA MAUDE)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 pressed2025-02-26
Recall · severity: moderate · FDA · recall ordered
- da Vinci endoscope: light left on burned the patient after resting on the thigh (FDA MAUDE)2025-01-21
Injury · severity: serious · FDA (MAUDE)
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
- Intuitive recalls da Vinci 8mm Mega SutureCut Needle Driver over frayed or broken grip cables2024-12-19
Recall · severity: serious · FDA · recall ordered
- Intuitive recalls da Vinci 8mm Horizon Small Clip Applier over frayed or broken grip cables2024-12-19
Recall · severity: serious · FDA · recall ordered
Recall · severity: moderate · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
Recall · severity: moderate · FDA / Health Canada · recall ordered
- da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments2022-10-07
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
- Intuitive recalls Ion Flexision 19G Biopsy Needle over a sheath tip that can separate from the shaft2021-08-06
Recall · severity: serious · FDA · recall ordered
- Intuitive Ion Endoluminal System recalls (fully-articulating catheter and Flexison biopsy needle)2020-12-02
Recall · severity: moderate · FDA · recall ordered
- Intuitive recalls Ion Fully Articulating Catheter over a distal tip ring that can become dislodged2020-10-23
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
- Intuitive recalls da Vinci EndoWrist Stapler 45 over increased Stapler Firing Failed complaints2016-07-14
Recall · severity: serious · FDA · recall ordered
- Intuitive recalls da Vinci 30-degree 8mm Endoscope over risk of patient harm from monopolar energy2015-11-23
Recall · severity: serious · FDA · recall ordered
Recall · severity: serious · FDA · recall ordered
Regulatory action · severity: serious · FDA · other
Recall · severity: critical · FDA · recall ordered
- Intuitive recalls da Vinci 8mm Maryland Bipolar Forceps over a cautery plug insert that can dislodge2013-05-08
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 deployments. This is a genuine data gap, not a rounding to zero: no incident count above can be turned into a defensible rate without it. NHTSA's SGO dataset itself does not publish exposure denominators, and there is no standardized, regulator-verified nationwide source for AV fleet mileage or ride counts today. Where a company self-publishes a mileage figure, it is not independently audited and is not shown here as DEPLOY-verified data.
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.
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.
Full company record: Intuitive Surgical