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RobotRisk / Johnson & Johnson (Abiomed) / 2026-05
other · malfunction

FDA warns on J&J Abiomed Automated Impella Controllers after death linked to software error

S5 · 05/2026 · Johnson & Johnson (Abiomed) · USA

Record

CompanyJohnson & Johnson (Abiomed)
Categoryother
Typemalfunction
Date05/2026
Time of daynot documented
LocationUSA
SeverityS5 (fatality or catastrophic loss)
Scale-
Confidencemedium
VerificationYes - adversarially checked against the cited source
SourceMassDevice

What happened

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.

Johnson & Johnson (Abiomed) record context

Johnson & Johnson (Abiomed) vs other alternatives

other context

other: entries by year

14282017 S1: 12017 S5: 12172019 S3: 11192021 S3: 11212022 S5: 11222023 S3: 12023 S4: 23232024 S1: 22024 S2: 42024 S3: 32024 S4: 72024 S5: 521242025 S1: 12025 S2: 72025 S3: 62025 S4: 82025 S5: 628252026 S1: 12026 S2: 92026 S3: 32026 S4: 22026 S5: 31826
S1S2S3S4S5

other: failure modes

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malfunction context

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malfunction: severity profile

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