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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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Product Description
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Z-1471-2026 - Impella RP. Product Code: 0046-0011. 1 02/27/2026 FEI # 1220648
Abiomed, Inc.
Z-1469-2026 - Impella RP with SmartAssist. Product Code: 0046-0035. 1 02/27/2026 FEI # 1220648
Abiomed, Inc.
Z-1470-2026 - Impella RP Flex with SmartAssist. Product Code: 1000323. 1 02/27/2026 FEI # 1220648
Abiomed, Inc.
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