Abiomed Impella RP Flex Introducer Kit
Abiomed recalls Impella RP Flex introducer kits over sheath leakage risk from manufacturing defects.
Immediately discontinue use of affected Impella RP Flex pump sets and return them to Abiomed for replacement. Contact Abiomed Customer Service at 1-888-283-2228 for instructions on returning the product and obtaining a replacement.
Why it was recalled
Abiomed is recalling Impella RP Flex with SmartAssist pump sets containing 14Fr and 23Fr Introducers due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defects are not visually detectable and may compromise patient safety.
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.
| Product | UPC | Recall # |
|---|---|---|
| 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 accessories | 00813502012279, 00813502011876 | Z-2682-2026 |
| 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 accessories | 00813502011708, 00813502012729 | Z-2685-2026 |
| 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 accessories | 00813502013474 | Z-2683-2026 |
| ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories | 00813502011340 | Z-2692-2026 |
| ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories | 00813502012873, 00813502013344, 00813502013368, 04260113630280 | Z-2689-2026 |
| 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 accessories | 00813502011715, 00813502012736 | Z-2686-2026 |
| ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories | 00813502013054 | Z-2688-2026 |
| 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 accessories | 00813502012811 | Z-2681-2026 |
+5 more affected products. See the full list at the official source below.
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Abiomed, Inc.
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification