The Recall Desk
SevereFDA (Devices)·Z-2680-2026·Announced 2026-07-22

Abiomed Impella Introducer Kit recalled for potential fluid leakage

Oscor Inc. is recalling the Abiomed Impella Hemostatic Peel Away Introducer System (23F) due to manufacturing defects that may cause leakage from the sidearm, under the sheath cap, or along the hub region.

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 material identifies this as an FDA Class I recall. Per the rubric, FDA Class I recalls receive a minimum severity score of 4 (Severe).

Plain-English summary

Oscor Inc. is recalling the Abiomed REF 0052-3006 Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F, a heart pump accessory. The recall affects 32,934 units distributed in Massachusetts.

The product may leak fluid from the sidearm, under the sheath cap, and along the hub score lines in the hub region due to manufacturing issues. These potential leaks could compromise the device's function during use.

Patients and healthcare providers who have this product should contact their medical center or Oscor Inc. for guidance on next steps. The recall includes all lots within the expiry date matching GTIN 00885672009755 or 00813502011609.

The recalled product

Product
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
Manufacturer
Oscor Inc.
Category
Medical Device — Cardiovascular / Heart Pump Accessory
Hazard
  • fluid-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)

  • All Lots within Expiry/GTIN:00885672009755/00813502011609

Distribution

Distributed in 1 state:

  • MA

Related recalls

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