# Auris Health safety record

7 incident(s) on file for Auris Health, 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 Auris Health](/companies/auris-health.md)

## Incidents (7)

- [Auris Monarch bronchoscope: Navigation EM error at the docking station, scope removed (FDA MAUDE)](/incidents/auris-monarch-bronchoscope-navigation-em-error-maude-2026.md) (2026-05-08): Malfunction · severity: moderate · FDA (MAUDE)
- [Auris Monarch: patient developed pneumothorax post-procedure requiring chest-tube placement (FDA MAUDE)](/incidents/auris-monarch-pneumothorax-chest-tube-maude-2026.md) (2026-04-30): Injury · severity: serious · FDA (MAUDE)
- [Auris Health (J&J) recalls Monarch over unanticipated robotic arm positioning toward patient-left](/incidents/auris-monarch-arm-positioning-patient-left-recall-2026.md) (2026-01-21): Recall · severity: serious · FDA · recall ordered
- [Auris Health (J&J) recalls Monarch bronchoscopes over out-of-range leak-test results](/incidents/auris-monarch-bronchoscope-leak-test-recall-2025.md) (2025-10-18): Recall · severity: serious · FDA · recall ordered
- [Auris Health (J&J) recalls Monarch over a power-cord strain-relief electrical short](/incidents/auris-monarch-power-cord-strain-relief-short-recall-2025.md) (2024-08-02): Recall · severity: serious · FDA · recall ordered
- [Auris Health (J&J) recalls Monarch robotic bronchoscopy platform over software bug that can flip the virtual scope view](/incidents/auris-monarch-flipped-image-software-recall-2023.md) (2023-10-18): Recall · severity: serious · FDA · recall ordered
- [Auris Health (J&J) recalls Monarch Aspirating Biopsy Needle over reports of needle breakage](/incidents/auris-monarch-aspirating-biopsy-needle-breakage-recall-2020.md) (2019-04-19): Recall · severity: serious · FDA · recall ordered

## Exposure

DEPLOY does not have exposure data (deployment-hours, miles driven, or rides given) on file for Auris Health. 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 Auris Health's safety record?**

DEPLOY has 7 incidents on file for Auris Health, 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 Auris Health safer than a human driver?**

DEPLOY does not have exposure data (miles driven or hours operated) on file for Auris Health, 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.

**Does DEPLOY redact or omit crash details for Auris Health?**

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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