RobotRisk › Johnson & Johnson (Abiomed) › ~May 2026
FDA warns on J&J Abiomed Automated Impella Controllers after death linked to software error
S5 · ~May 2026 · Johnson & Johnson (Abiomed) · USA
Record
| Company | Johnson & Johnson (Abiomed) |
| Industry | Other |
| Type(s) | malfunction |
| Date | ~May 2026 (month precision) |
| Time of day | not documented |
| Location | USA |
| Severity | (fatality or catastrophic loss) |
| Scale | not documented |
| Confidence | medium |
| Verified flag | Yes - independently re-checked against the cited source |
Summary
FDA issued a safety communication on Abiomed's Automated Impella Controller after a patient death was associated with a software error affecting the device's operation.
Primary source
Publisher: MassDevice · Retrieved: 2026-09-16
Supporting source rows (1)
| Date | Supporting source row | Publisher | Link |
|---|---|---|---|
| ~May 2026 | FDA warns on J&J Abiomed Automated Impella Controllers after death linked to software error | MassDevice | MassDevice |
Other context
malfunction context
Johnson & Johnson (Abiomed) industry position
Related incidents
Other Johnson & Johnson (Abiomed) entries
- None on file.
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