Products: automation-operator. Risk band: Elevated RobotRisk index 30.5/100 (incidents/exposure, time-weighted) · 89th percentile of 62 other companies.
Johnson & Johnson (Abiomed)'s record consists of a single entry: a May 21, 2026 FDA warning concerning Abiomed Automated Impella Controllers following a death linked to a software error, rated severity 5, the maximum in this dataset. This one event produces an index of 30.7, placing the company at the 87.1st percentile within the broad other category. The record is regulator-driven, originating from an FDA warning tied to a software malfunction in a life-support medical device, rather than a pattern of repeated incidents. With a single row on file, the severity is high but the record does not establish frequency or trajectory.
| Sev | Date | Type | Location | Incident | Source |
|---|---|---|---|---|---|
| S5 | 05/2026 | malfunction | USA | FDA warns on J&J Abiomed Automated Impella Controllers after death linked to software error | MassDevice |