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Updated 2024-09-11

Abiomed, Inc. recalls Impella CP Smart Assist Set; Product Code: 1000402;

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Recalled Product

Impella CP Smart Assist Set; Product Code: 1000402;

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code: 1000402; UDI-DI: 00813502012873; Serial Numbers: 385946 385942 385944 385945 385950 385941 385949 385947 385948 385943 392855 392853 392854 392852 392851 392848 392849 392879 392878 427388 427387 427386 430896 430875 430874 430873 430872 430871 430870 430869 430868 430867 431652 430895 430894 486297 486298 486299 486300; Batch Numbers: 2023251705 2023251861 2023251862 2023251869 2023251872 2023251874 2023251876 2023251879 2023251881 2023251902 2023283187 2023283192 2023283194 2023283196 2023283200 2023283208 2023283216 2024305462 2024305463 2024305465 2024305466 2024305467 2024308137 2024308138 2024308139 2024308141 2024308143 2024308144 2024308146 2024308148 2024308149 2024308150 2024308159 2024308160 2024308162 2025501277 2025501292 2025501297 2025501301;

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

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