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FDA: Abbott's HeartMate II controller recall warrants Class I status

The FDA has labeled a recall of 28,882 HeartMate II System controllers initiated by Abbott Laboratories as Class I following reports of 70 malfunction incidents and 26 deaths after patients replaced their units at home. "We are updating its alert guides, conducting a software upgrade and adding controller alignment markings for the HeartMate II System Controller as part of a continued effort to ensure patients are successfully able to exchange their pocket controller in emergency situations," said Abbott spokesman Justin Paquette.

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