Medical Device

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000

Recall date: 2026-07-01 · Source: FDA_DEVICE

Brand / Firm

Product

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.

Reason for recall

Potential for thrombus formation during prolonged use of the introducer.

Units affected

168 units

Description

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.