The Recall Desk
SevereFDA (Devices)·Z-2114-2023·Announced 2023-07-26

Abiomed Impella 5.5 pump recalled due to impeller blade damage risk

Abiomed is recalling the Impella 5.5 with SmartAssist pump due to a risk of impeller blade destruction when used with aortic valve replacement devices. Damage can result in low blood flow and systemic embolization, where broken pump pieces may enter the bloodstream.

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: FDA Class I designation requires a minimum severity score of 4. The recall involves potential destruction of critical pump components and risk of systemic embolization, though the source does not report any actual injuries or deaths.

Plain-English summary

The Impella 5.5 with SmartAssist is a small mechanical pump inserted into the heart to assist blood flow. The FDA has classified this recall as Class I due to a potential interaction between the pump's motor housing and stents used in transcatheter aortic valve replacement (TAVR) procedures.

When the motor housing unintentionally contacts the aortic valve stent, it can destroy the impeller blades inside the pump. This damage reduces the pump's ability to circulate blood effectively, resulting in low blood flow. Additionally, fractured pieces of the impeller blades may enter the bloodstream, posing a risk of systemic embolization.

The affected devices have been distributed worldwide, including throughout the United States.

The recalled product

Product
Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
Manufacturer
Abiomed, Inc.
Category
Medical Device — Cardiac Support
Hazard
Affected units
9,252

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 (2)

  • UDI-DI: 00813502011531
  • 00813502012828

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Abiomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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