medical HIGH RISK
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Updated 2026-07-22

Abiomed, Inc. recalls ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing

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Recalled Product

ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories

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Hazard / Issue

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Pump Set Code 0048-0044; Introducer Product Code 0052-3046. GTIN: 00813502012200. All current batches in field.

✅ 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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