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# Abiomed Recalls Impella 5.5. Blood Pump
- URL: https://www.fdaweb.com/abiomed-recalls-impella-5-5-blood-pump/
- Published: 2023-05-19T12:00:00.000Z
- Updated: 2026-09-14T18:33:15.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154494

Abiomed has recalled (Class 1) its Impella 5.5 with SmartAssist catheter, an intravascular micro axial blood pump that supports a patient’s circulatory system. The recall was decided after the company experienced a “heightened complaint rate for purge leaks,” according to a [recall notice](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=199296&ref=fdaweb.com). FDA says the problem was related to the device’s design. Last month, Abiomed sent an urgent medical device recall (removal) notification letter that noted the company will replace all affected pumps using a phased replacement approach.