← All recalls
Medical Device

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product C

Recall date: 2026-07-01 · Source: FDA_DEVICE
Brand / Firm
Abiomed, Inc.
Product
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Reason for recall
Potential for thrombus formation during prolonged use of the introducer.
Units affected
7 units
Description
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
View official recall notice →