Has Abiomed, Inc. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 8 total FDA actions tied to Abiomed, Inc., including 8 recalls and 0 warning letters.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

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.

FDA Recall Database: Class I Recall: Impella CP Set with SmartAssist. Product Codes: 1000080,… by Abiomed, Inc.

Here's the summary: FDA classified a recall by Abiomed, Inc. as Class I, reported June 24, 2026. The affected product is Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP. (recall number Z-2457-2026). Reason for 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. Status: Ongoing.

Key facts

Recalling firm	Abiomed, Inc.
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Classification	Class I
Recall number	Z-2457-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for 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.

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.

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

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

Has Abiomed, Inc. had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 8 total FDA actions tied to Abiomed, Inc., including 8 recalls and 0 warning letters.
What is the FDA recall number for this event?: FDA recall number Z-2457-2026.
What is the current status of this recall?: Status as recorded by FDA: Ongoing.
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.

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Full FDA history for Abiomed, Inc.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Recall Database: Class I Recall: Impella CP Set with SmartAssist. Product Codes: 1000080,… by Abiomed, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-abiomed-inc-z-2457-2026

MLA

"FDA Recall Database: Class I Recall: Impella CP Set with SmartAssist. Product Codes: 1000080,… by Abiomed, Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-abiomed-inc-z-2457-2026.

Chicago

Argus HQ Research. "FDA Recall Database: Class I Recall: Impella CP Set with SmartAssist. Product Codes: 1000080,… by Abiomed, Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-abiomed-inc-z-2457-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_abiomed_inc_z_2457_2026_2026,
  title = {FDA Recall Database: Class I Recall: Impella CP Set with SmartAssist. Product Codes: 1000080,… by Abiomed, Inc.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-abiomed-inc-z-2457-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗