Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Impella Connect

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Impella Connectsee related information
Date Initiated by FirmDecember 06, 2023
Date PostedJanuary 04, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0636-2024
Recall Event ID 93581
PMA NumberP170011 P140003 
Product Classification Temporary non-roller type right heart support blood pump - Product Code PYX
ProductImpella 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
ActionOn 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 Commercen/a - no physical product
DistributionDomestic distribution nationwide.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = PYX
-
-