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Abiomed, Inc.: Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.

Medical DevicesSource: FDA (device) · Date: 2026-07-01

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Abiomed, Inc.
Product
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Reason / hazard
Potential for thrombus formation during prolonged use of the introducer.
Classification
Class I
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
Recall initiated
2026-05-22
Code info
Impella Set Product Code: 1000434; GTIN: 00813502012996; Serial Numbers: N/A. Introducer Product Code: 1000434; Batch Number: 2038639.
Product quantity
3 units
Voluntary mandated
Voluntary: Firm initiated
City
Danvers
State
MA
Country
United States
Event id
99002
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