Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 3. Impella Optical Controller, Packaged, IN; Product Code:
Abiomed, Inc.
The hazard
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly. FDA Class I recall.
The remedy
Follow FDA guidance
About this recall
Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1. Impella Optical ControllerModel PackagedModel Product Code: 0042-0010-AUModel UDI-DI: 00813502010930Model Serial Numbers: IC5130Model IC5131Model 2. Impella Optical ControllerModel Product Code: 0042-0010-EUModel UDI-DI: 00813502010961Model Serial Numbers: IC12955Model IC12978Model IC13013Model IC13027Model IC13042Model IC13202Model IC13223Model IC13228Model IC6947Model IC6948Model IC7625Model IC7740Model IC7741Model IC8064Model IC8065UPC 00813502010930UPC 00813502010961UPC 00813502011425UPC 00813502010978UPC 00813502010985Would you have heard about this one?
RapidRecall watches everything you own against every new federal recall and emails you the moment something you bought turns up. Free for your most important items.
Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.