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Medical Device

Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.

Recall date: 2026-07-01 · Source: FDA_DEVICE
Brand / Firm
Abiomed, Inc.
Product
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Reason for recall
Potential for thrombus formation during prolonged use of the introducer.
Units affected
17 units
Description
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
View official recall notice →