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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-0209-2027 - Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump. 1 10/28/2026 FEI # 1220648
Abiomed, Inc.
Z-0210-2027 - Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump. 1 10/28/2026 FEI # 1220648
Abiomed, Inc.
Z-0208-2027 - Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump. 1 10/28/2026 FEI # 1220648
Abiomed, Inc.
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