The Recall Desk
SevereFDA (Devices)·Z-2682-2026·Announced 2026-07-22

ABIOMED Impella CP Heart Pump Introducer Sheath Leakage Risk

Abiomed is recalling the Impella CP heart pump set (87,277 units worldwide) due to potential leakage from the introducer sheath that cannot be visually detected by users. The defect affects the 14Fr and 23Fr introducers included in every pump set.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA has classified this recall as Class I. Per the rubric, an FDA Class I recall with a Class II or Class I agency classification is scored 4 or higher. Although no specific injuries or illnesses are reported in the source text, the Class I designation reflects the agency's determination that this defect has reasonable potential to cause serious adverse health consequences or death.

Plain-English summary

Abiomed, Inc. is recalling the ABIOMED Impella CP Set (Pump Set Code 0048-0003, Introducer Product Code 0052-3046) due to a potential for introducer sheath leakage from under the sheath cap and along the hub score lines. The leakage may occur in 14Fr and 23Fr introducers, and these manufacturing defects are not visually detectable by users.

Since 14Fr or 23Fr introducers are provided in every pump set, all current batches in the field are affected. The product has been distributed worldwide, including throughout the US, and to multiple countries including Australia, Canada, China, France, Germany, Japan, South Korea, Spain, Switzerland, the United Kingdom, and many others.

Approximately 87,277 units have been distributed. Healthcare providers and patients using this device should be aware of the leakage risk. Users should contact Abiomed, Inc. for specific guidance regarding affected units and recommended actions.

The recalled product

Product
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
Manufacturer
Abiomed, Inc.
Category
Medical Device — Cardiology / Circulatory Support
Hazard
  • device-leakage
  • fluid-leak

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Pump Set Code 0048-0003
  • Introducer Product Code 0052-3046. GTIN: 00813502012279
  • 00813502011876. All current batches in field.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category