FDA (Devices) recall action 98276
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Abiomed is recalling the Impella RP Flex with SmartAssist because the differential pressure sensor may malfunction, causing sensor values to drift. The FDA has classified this recall as Class I.
Abiomed is recalling the Impella RP with SmartAssist because the differential pressure sensor may malfunction, causing sensor values to drift. The FDA has classified this recall as Class I.
Abiomed is recalling the Impella RP, product code 0046-0011, because the differential pressure sensor may malfunction, causing sensor values to drift. The FDA has classified this recall as Class I.