Date Initiated by Firm |
December 06, 2023 |
Date Posted |
January 04, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0636-2024 |
Recall Event ID |
93581 |
PMA Number |
P170011 P140003 |
Product Classification |
Temporary non-roller type right heart support blood pump - Product Code PYX
|
Product |
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data. |
Code Information |
UDI-DI 00813502011647
Software version 1.1 - 3.17.1 |
Recalling Firm/ Manufacturer |
Abiomed, Inc. 24 Cherry Hill Dr Danvers MA 01923-2575
|
For Additional Information Contact |
978-646-1400
|
Manufacturer 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
|
FDA Determined Cause 2 |
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 in Commerce |
n/a - no physical product |
Distribution |
Domestic distribution nationwide. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
PMA Database |
PMAs with Product Code = PYX and Original Applicant = Abiomed, Inc.
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