Official recall record
Impella CP Smart Assist Set; Product Code: 1000402;
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-08-05
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00813502012873
- Brand on record
- Abiomed, Inc.
What the authority reported
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
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 2026-05-31.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2026-06-11 · US FDA — Medical Devices
ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessori
Other recalls from this brand
- 2026-06-11 · US FDA — Medical Devices
ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and - 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 CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm
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