Notice names this product. Abiomed’s Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP is named in FDA Class I recall Z-2599-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Potential for thrombus formation during prolonged use of the introducer. Identifying details: Impella Set Product Code: 1000434; GTIN: 00813502012996; Serial Numbers: N/A. Introducer Product Code: 1000434; Batch Number: 2038639.. Units affected: 3 units. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Potential for thrombus formation during prolonged use of the introducer.
Company / brand: Abiomed recalls
Affected product: Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP recall status
Official ID Z-2599-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.