Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 4
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
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 4. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 6. Impella Controller, Packaged, US; Product Code: 0042-0000-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 ControllerModel PackagedModel Product Code: 0042-0000-CAModel UDI-DI: 00813502010022Model Serial Numbers: IC1324Model IC1346Model IC1480Model IC1481Model IC1543Model IC1544Model IC1572Model IC1595Model IC1598Model IC1664Model IC1665Model IC1715Model IC1769Model IC1790Model IC1791Model IC1911Model IC1912Model IC1913Model IC2032Model IC2033Model IC2034UPC 00813502010022UPC 00813502011289UPC 00813502011418UPC 00813502010428UPC 00813502011296Would 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.