Recalling firm
Abiomed, Inc.
Product type
Device
Status
Ongoing
Report date
2026-07-01
Distribution
Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
Firm state
MA
Product quantity
17 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Potential for thrombus formation during prolonged use of the introducer.
Product description
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Code / lot info
Impella Set Product Code: 1000435; GTIN: 00813502013009; Serial Numbers: N/A. Introducer Product Code: 1000435; Batch Numbers: 2038707, 2045782.
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.