CW ClaimWatch Consumer alert tracker

Recall

Abiomed, Inc.: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP. Recall

Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support. Product details: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

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Verification

Official-source record

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Agency
FDA
Record ID
Z-2457-2026
Canonical
https://claimwatch-mvp.vercel.app/item/abiomed-inc-impella-cp-set-with-smartassist-product-codes-1000080-1000851-0048-0014-0048-0/

What happened?

Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support. Product details: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

Who may be affected?

US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan

What should consumers do?

Affected quantity: 10 units

Official source

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FAQ

Is this page official?

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Is this legal, medical, or financial advice?

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

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