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FDA Issues Class I Recall for Abiomed Impella CP Over Clot Risk

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By People's Justice

What happened

The FDA issued a Class I recall for the Abiomed Impella CP Set with SmartAssist (10th Generation), citing the potential for thrombus (blood clot) formation during prolonged use of the affected 14Fr Low Profile Introducer Kits. A Class I recall is the FDA's most serious category, indicating a reasonable probability that use of the device could cause serious injury or death.

Event date:

Source: api.fda.gov

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    The FDA issued a Class I recall for the Abiomed Impella CP Set with SmartAssist (10th Generation), citing a potential for thrombus (blood clot) formation during prolonged use of the included 14Fr Low Profile Introducer Kits. A Class I recall is the most serious category, reserved for situations where use of a device may cause serious injury or death.

    Source: api.fda.gov