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Abiomed Impella RP Flex Introducer
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MEDICAL DEVICE RECALLCRITICAL

Abiomed Impella RP Flex Introducer

Abiomed recalls Impella RP Flex introducers over sheath leakage risk.

What to do

Do not use the affected Impella RP Flex with SmartAssist Set. Contact Abiomed for instructions on returning the product and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
Z-2681-2026
Agency
FDA
Firm
Abiomed, Inc.
Recall ID
98893
Status
ONGOING

Why it was recalled

Abiomed is recalling the Impella RP Flex with SmartAssist Set due to a potential for introducer sheath leakage from under the sheath cap and along the hub score lines in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user and could lead to serious patient harm.

Is mine affected?

This recall covers 13 products. Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductRecall #UDI-DI
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessoriesZ-2682-202600813502012279, 00813502011876
ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessoriesZ-2685-202600813502011708, 00813502012729
ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessoriesZ-2683-202600813502013474
ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessoriesZ-2692-202600813502011340
ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessoriesZ-2689-202600813502012873, 00813502013344, 00813502013368, 04260113630280
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessoriesZ-2686-202600813502011715, 00813502012736
ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessoriesZ-2688-202600813502013054
ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessoriesZ-2681-202600813502012811
Show all 13 products
ProductRecall #UDI-DI
ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessoriesZ-2691-202600813502012200
ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessoriesZ-2693-202600813502011449
ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessoriesZ-2690-202600813502011609
ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessoriesZ-2687-202600813502012453
ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessoriesZ-2684-202600813502012910

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification