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
7 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Potential for thrombus formation during prolonged use of the introducer.
Product description
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Code / lot info
Impella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530.
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.