The Recall Desk
SevereFDA (Devices)·Z-2686-2026·Announced 2026-07-22

ABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath

Abiomed, Inc. is recalling ABIOMED Impella CP Introducer Kit 14 Fr units worldwide due to potential introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable.

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: This is an FDA Class I recall of a medical device used in critical heart-support procedures. Class I recalls are defined as presenting serious adverse health consequences or death, and this sheath leakage defect in a heart pump component carries inherent risk of serious patient harm during use.

Plain-English summary

Abiomed, Inc. is recalling 1,223 units of the ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm (Pump Set Code 0052-0039, Introducer Product Code 0052-3053) due to a potential for introducer sheath leakage from under the sheath cap and along the hub score lines. These manufacturing issues affect 14Fr and 23Fr Introducers and are not visually detectable by the user.

The defective Introducers are provided in every pump set and have been distributed worldwide, including throughout the US, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Japan, Mexico, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom, and numerous other countries. All current batches in the field are affected.

Users who have received affected units should contact Abiomed, Inc. for additional information and guidance regarding their specific devices.

The recalled product

Product
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories
Manufacturer
Abiomed, Inc.
Category
Medical Device — Cardiac Support / Heart Pump
Hazard
  • sheath-leakage
  • device-defect

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 0052-0039
  • Introducer Product Code 0052-3053. GTIN: 00813502011715
  • 00813502012736. All current batches in field.

Distribution

Distributed nationwide across the United States.

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