Recall Z-0636-2024 ยท PYX Temporary Non-Roller Type Right Heart Support Blood Pump
Abiomed, Inc.
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
| Date | Jan 4, 2024 (initiated Dec 6, 2023) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.