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U.S. Department of Health and Human Services

Medical Device Recalls
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Related Medical Device Recalls
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Z-3150-2026 - Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; P... 1 09/16/2026 FEI # 1220648
Abiomed, Inc.
Z-3149-2026 - Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, ... 1 09/16/2026 FEI # 1220648
Abiomed, Inc.
Z-3148-2026 - Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged... 1 09/16/2026 FEI # 1220648
Abiomed, Inc.
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