Official recall record
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-06-11
- Country of alert
- United States
- Alert level
- Class I
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00813502012279
- Brand on record
- Abiomed, Inc.
What the authority reported
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 to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.
Record last checked against the registry on 2026-09-16.
Same barcode in other registries
The same EAN appears in 3 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2024-08-05 · US FDA — Medical Devices
Pump 381 Pump Set (US); Product Code: 1000080; - 2024-05-31 · US FDA — Medical Devices
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump - 2026-05-18 · US FDA — Medical Devices
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Other recalls from this brand
- 2026-06-11 · US FDA — Medical Devices
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm - 2026-06-11 · US FDA — Medical Devices
ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Cod - 2026-06-11 · US FDA — Medical Devices
ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP.
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