FDA Medical Device Recalls (openFDA)
Abiomed, Inc.: Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
- Recall number
- Z-0636-2024
- Recalling firm
- Abiomed, Inc.
- Product
- Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
- Status
- Open, Classified
- Initiated
- 2023-12-06
- Posted
- 2024-01-04
- Terminated
- not on file
- Reason
- 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
- Root cause
- No Marketing Application
- Action
- On December 6, 2023, the firm notified affected customers via a Correction Letter delivered by the ImpellaConnect.com portal. Customers were informed that the affected features were disabled from the web-based portal. If you have questions or concerns regarding this notice, please contact ImpellaConnect@abiomed.com and/or your local clinical field staff.
- Quantity
- n/a - no physical product
- Distribution
- Domestic distribution nationwide.
- Lot, serial or model codes
- UDI-DI 00813502011647 Software version 1.1 - 3.17.1
- 510(k) numbers
- not on file
- PMA numbers
- ["P170011","P140003"]
- Product code
- PYX
- Firm FEI
- 1220648
- Firm city
- Danvers
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28