# Class II recall Z-3251-2026: Abiomed, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3251-2026 |
| Recalling firm | Abiomed, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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, Packaged, EU; Product Code: 0042-0000-EU.     3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK.     4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.     5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU.    6. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US.    7. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0 |
| Reason | 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. |
| Quantity | 3,322 units |
| Distribution | Worldwide - US Nationwide and the countries of Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Luxembourg, Poland, Spain, Switzerland, United Kingdom. |
| Recall initiated | 2019-02-19 |
| Reported | 2026-09-30 |
| Firm location | Danvers, MA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 36 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3251-2026%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.