FDA Class I Recall: Abiomed Impella CP Set with SmartAssist (10th Generation)… by Abiomed, Inc.

Key facts

What consumers should do

Facilities and clinicians holding an affected lot or unit should stop using it for the indication described in the recall notice and quarantine remaining stock pending instructions from Abiomed, Inc.. FDA recall records for devices typically direct the recalling firm to notify known accounts (hospitals, distributors, clinics) directly with a recall letter describing the specific corrective action — replacement, field correction, or return. Anyone who received Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834. through a distributor rather than directly from Abiomed, Inc. should still confirm with their supplier whether their specific lot or serial number is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Abiomed, Inc. directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

What this classification means

A Class I recall is FDA's most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case — it reflects FDA's assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because Class I is reserved for the highest-risk defects, professionals and consumers handling an affected lot are generally advised to treat the recall as time-sensitive rather than routine.

Abiomed, Inc.’s FDA history

Argus HQ has recorded 8 total FDA actions tied to Abiomed, Inc.: 0 warning letters, 8 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

Is Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14 recalled?

Yes. FDA lists a Class I recall by Abiomed, Inc. for Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834., reported July 1, 2026, with status "Ongoing." FDA recall number: Z-2601-2026.

What is the recall class for Abiomed, Inc.'s Abiomed Impella CP Set with SmartAssist (10th Generation) co recall?

FDA classified this recall as Class I. Class I is FDA's most serious classification, reserved for defects with a reasonable probability of serious health consequences or death.

Why was Abiomed Impella CP Set with SmartAssist (10th Generation) co recalled?

FDA's recall record states the reason as: Potential for thrombus formation during prolonged use of the introducer.

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