Official recall notice

FDA DeviceClass INotable

Abiomed 14 Fr x 25 cm Low Profile Introducer Recall (Jul 2026)

Product: 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
FDA class
Class I

Why it was recalled

Hazard

Potential for thrombus formation during prolonged use of the introducer.

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Product description

Potential for thrombus formation during prolonged use of the introducer.

Affected products

Impella Set Product Code: 1000435; GTIN: 00813502013009; Serial Numbers: N/A. Introducer Product Code: 1000435; Batch Numbers: 2038707, 2045782.

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