Impella Connect — Class II medical device recall Z-0636-2024
Ongoing recall by Abiomed, Inc., reported 2024-01-10, distributed nationwide. The following features have been disabled from the web-based portal because the FDA has not evaluated these fe
| Recall number | Z-0636-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2023-12-06 |
| Classified | 2024-01-04 |
| Reported by FDA | 2024-01-10 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00813502011647 |
Product
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
Reason for recall
The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0636-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.