medical HIGH RISK
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Updated 2026-06-24

Abiomed, Inc. recalls Impella CP Set with SmartAssist. Product Codes: 1000080, 100

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Recalled Product

Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

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Hazard / Issue

Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

Issued by

FDA

Affected States: GA, IA, NE, PA, TX, WA, WI
Lot/Code Info: GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216).

✅ 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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