CW ClaimWatch Consumer alert tracker

Recall

Abiomed, Inc.: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000 Recall

Potential for thrombus formation during prolonged use of the introducer. Product details: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.

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Agency
FDA
Record ID
Z-2601-2026
Canonical
https://claimwatch-mvp.vercel.app/item/abiomed-inc-abiomed-impella-cp-set-with-smartassist-10th-generation-containing-affected-14/

What happened?

Potential for thrombus formation during prolonged use of the introducer. Product details: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.

Who may be affected?

Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.

What should consumers do?

Affected quantity: 168 units

Official source

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No. This page is informational. Always confirm eligibility, deadlines, and safety instructions through official sources.

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