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

Yes. Argus HQ has recorded 21 total FDA actions tied to Abiomed, Inc., including 21 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: ABIOMED Impella CP Set, Pump Set Code 0048-0014;… by Abiomed, Inc.

Here's the summary: FDA classified a recall by Abiomed, Inc. as Class I, reported 20260722. The affected product is ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories (recall number Z-2689-2026). Reason for recall: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.. 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	ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
Classification	Class I
Recall number	Z-2689-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

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 this record is filed as Class I, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. 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.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Abiomed, Inc.. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Abiomed, Inc. should confirm with their supplier whether their specific lot or unit 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 21 total FDA actions tied to Abiomed, Inc.: 0 warning letters, 21 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 21 total FDA actions tied to Abiomed, Inc., including 21 recalls and 0 warning letters.
What is the FDA recall number for this event?: FDA recall number Z-2689-2026.
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: ABIOMED Impella CP Set, Pump Set Code 0048-0014;… by Abiomed, Inc.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/abiomed-z-2689-2026-2026-07-22

MLA

"FDA Recall Database: Class I Recall: ABIOMED Impella CP Set, Pump Set Code 0048-0014;… by Abiomed, Inc.." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/abiomed-z-2689-2026-2026-07-22.

Chicago

Argus HQ Research. "FDA Recall Database: Class I Recall: ABIOMED Impella CP Set, Pump Set Code 0048-0014;… by Abiomed, Inc.." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/recall/abiomed-z-2689-2026-2026-07-22.

BibTeX

@misc{argushq_argushq_ai_recall_abiomed_z_2689_2026_2026_07_22_2026,
  title = {FDA Recall Database: Class I Recall: ABIOMED Impella CP Set, Pump Set Code 0048-0014;… by Abiomed, Inc.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/recall/abiomed-z-2689-2026-2026-07-22},
  note = {Accessed: August 27, 2026}
}

Source: FDA.gov — Recalls ↗