Radar · device · signal

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella CRecall or enforcement action

Complete coverage checks before an early-window claim.

Statistical status

No screen yet

Receipt-date counts have not been screened.

Evidence score

—

Research priority weight, not a probability of causation or recovery.

Missing: none recorded

Competition

unknown

Observed in monitored channels only. Unknown is not zero.

Coverage unknown. Early-window label is blocked.

What changed

Qualitative review · notice
Enforcement report. This is a product action, not an injury count. Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to unreliable or missing placement signal, unresponsive start Impella soft key during disconnect/reconnect, and false Position in Ventricle alarm in certain AICs.
10/09/2026 · A recall may not involve the injury later investigated.
Read the source

Receipt dates are the reporting screen. Event dates are a separate, lag-sensitive series. They are not added together.

Basis	Window	Covered days	Reports	Expected	Fold	Complete

Unknown. Court and RECAP collectors are not in this release. Do not read a blank docket as zero lawsuits.

No firm pages or ad notes. Competition stays unknown until the panel records one.