The Recall Desk

FDA (Devices) recall action 99002

Abiomed, Inc. recalled 4 products on 2026-07-01

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2026-07-01
Critical
0
Units
195

Why these products were recalled

Potential for thrombus formation during prolonged use of the introducer.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • SevereFDA (Devices)··2026-07-01

    Abiomed Impella CP Set with SmartAssist 10th Generation Introducer Kits Recalled

    Abiomed is recalling certain Impella CP Set with SmartAssist (10th Generation) units with affected 14Fr Low Profile Introducer Kits due to potential for thrombus (blood clot) formation during prolonged use.

    Product
    Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
    Category
    Distribution
    6 states
  • SevereFDA (Devices)··2026-07-01

    Abiomed Impella CP Set with SmartAssist 10th Generation Introducer Kit Recall

    Abiomed is recalling Impella CP Set with SmartAssist (10th Generation) containing 14Fr Low Profile Introducer Kits due to potential thrombus (blood clot) formation during prolonged use of the introducer.

    Product
    Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
    Category
    Distribution
    6 states
  • SevereFDA (Devices)··2026-07-01

    Abiomed Impella CP Introducer Kit Recalled for Thrombus Risk

    Abiomed is recalling the 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP due to potential thrombus formation during prolonged use. The recall affects 17 units distributed in the United States and Japan.

    Product
    Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
    Category
    Distribution
    6 states
  • SevereFDA (Devices)··2026-07-01

    Abiomed Impella CP Introducer Kit recalled for thrombus formation risk

    Abiomed is recalling 3 units of the 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP due to potential for blood clot formation during prolonged use.

    Product
    Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
    Category
    Distribution
    6 states