medical HIGH RISK
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Updated 2026-03-11

Abiomed, Inc. recalls Impella RP Flex with SmartAssist. Product Code: 1000323.

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Recalled Product

Impella RP Flex with SmartAssist. Product Code: 1000323.

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Hazard / Issue

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code: 1000323. UDI-DI: 00813502012811.

✅ 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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