medical HIGH RISK Updated 2024-07-24

Abiomed, Inc. recalls Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-

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Recalled Product

Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump

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Hazard / Issue

Nine (9) Impella CP pumps failed inspection and were inadvertently released.

Issued by

FDA

Affected States: FL, MA, OH, TX
Lot/Code Info: Product No.: 1000080 (REF 0048-0003); UDI/DI: 00813502012279; Lot/Serial No.: Lot 1798046; Serial numbers: 504354, 504355, 504356, 504357, 504359, 504360, 504361, 504362, 504363.

✅ 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.

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