The Recall Desk
SevereFDA (Devices)·Z-2693-2026·Announced 2026-07-22

ABIOMED Intro Kit Heart Pump Introducer Sheath Leakage Risk

Abiomed, Inc. is recalling ABIOMED Intro Kit heart pump introducer sheaths due to potential leakage from under the sheath cap and along hub score lines. The manufacturing defects are not visually detectable by users.

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 source indicates this is an FDA Class I medical device recall, and the agency's classification rule mandates a score of 4 or higher. While no injuries or deaths are reported in the source text, the Class I designation—reserved for situations where there is a reasonable probability that the product will cause serious injury or death—justifies a Severe rating.

Plain-English summary

Abiomed, Inc. is recalling the ABIOMED Intro Kit, 14Fr x 13 and 25 cm (Pump Set Code 0052-0023-JP; Introducer Product Code 0052-3025-JP), due to a potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. Approximately 96 units have been distributed worldwide, including to the US and 35 other countries.

The manufacturing issues that create this leakage risk are not visually detectable by the user. Since 14Fr or 23Fr Introducers are provided in every pump set, all current batches in the field are potentially affected.

Users of this product should stop using the affected ABIOMED Intro Kit and contact Abiomed, Inc. for further instructions. Anyone with questions or who believes they have been affected should reach out to the manufacturer or consult the official FDA recall notice at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-2693-2026.

The recalled product

Product
ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
Manufacturer
Abiomed, Inc.
Category
Medical Device — Cardiac Support Device
Hazard
  • sheath-leakage
  • manufacturing-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 (1)

  • Pump Set Code 0052-0023-JP

Distribution

Distributed nationwide across the United States.

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