Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 2. Optical, AIC, Impella Connect, Packaged, CA; Product Code: 0042-0040-C
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, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 2. Optical, AIC, Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 3. Optical, AIC, Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 4. Optical, AIC, Impella Connect, Packaged, JP; Product Code: 0042-0040-JP. 5. Optical, AIC, Impella Connect, Packaged, UK; Product Code: 0042-0040-UK. 6. Optical, AIC, Impella Connect, Packaged, US; Product Code: 0042-0040-US. 7. Optical, AIC, Impella Connect, Packaged, KR; Product Code: 0042-0040-KR;
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1. OpticalModel AICModel Impella ConnectModel PackagedModel Product Code: 0042-0040-AUModel UDI-DI: 00813502012972Model Serial Numbers: IC12674Model IC12675Model IC13066Model IC10162Model IC10163Model IC10387Model IC10388Model IC10747Model IC10748Model IC11472Model IC11487Model IC11489Model IC11490Model IC11544Model IC11546Model IC11566Model IC12008Model IC12054Model IC12151UPC 00813502012972UPC 00813502012958UPC 00813502012217UPC 00813502011814UPC 00813502012484UPC 00813502011401Would you have heard about this one?
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