Johnson & Johnson (Abiomed)
Products: automation-operator. Risk band: High RobotRisk index 50.8/100 (severity- and time-weighted incidents) · ranked 6 of 45 among Other companies with incidents (53 tracked).
Analyst brief
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. Johnson & Johnson (Abiomed)'s index of 50.8 ranks 6 of 45 companies in Other with incident history. 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.
Risk index
Incident timeline
Comparisons over time
Per-type breakdown
| Incident type | Unique incidents | Share |
|---|---|---|
| malfunction | 1 | 100% |
Unique incident list
1 unique incident on file for this company.
| Sev | Date | Type | Location | Incident | Source |
|---|---|---|---|---|---|
| S5 | ~May 2026 | malfunction | USA | FDA warns on J&J Abiomed Automated Impella Controllers after death linked to software error | MassDevice |
S5 ~May 2026 · malfunction · FDA warns on J&J Abiomed Automated Impella Controllers after death linked to software error
| Sev | Date | Supporting source row | Source |
|---|---|---|---|
| S5 | ~May 2026 | FDA warns on J&J Abiomed Automated Impella Controllers after death linked to software error | MassDevice |
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