# Abiomed, Inc. recall opens medical devices buyers to alternatives (2026-09-30)

**Switch Opportunity Score:** 40/100

| Field | Value |
|---|---|
| Recalling firm | Abiomed, Inc. |
| Product | Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes.     1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.     2. Impella Controller,  |
| Replacement market | Medical devices |
| Agency | FDA medical devices |
| Severity | medium |
| Hazard | 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  |
| Recall date | 2026-09-30 |
| Switch angle | Buyers and retailers of the recalled medical devices need a compliant replacement; position your product on the specific hazard fixed, with documentation. |
| Original recall record | /report/fdapulse/z-3251-2026 |

## Why this score
- Medium severity.

Source: CPSC, NHTSA and FDA device recalls (via our recall feeds), mapped to replacement markets (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3251-2026%22). Last refreshed: 2026-11-04T15:17:38.587Z.
Built from official CPSC, NHTSA and FDA recall data; market mapping is our classification. Do not make claims about a competitor's recall beyond what the agency published, and follow advertising and comparative-claims rules. Not a consumer report and may not be used for FCRA purposes. Informational only; not legal, investment or procurement advice. Not affiliated with any agency or company listed.