The Recall Desk
HighFDA (Devices)·Z-2350-2021·Announced 2021-09-01

Terumo Advanced Perfusion System Electronic Patient Gas System Recalled for Control Failure

The Terumo Advanced Perfusion System 1 Electronic Patient Gas System is recalled for intermittent initialization failures that disable the primary control interface, requiring use of backup local controls.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device critical to surgical perfusion procedures. Although no injuries or deaths have been reported, the intermittent control system failure represents a significant risk of harm during use, meeting the criterion for a high-severity risk-of-harm product without reported illness.

Plain-English summary

The Terumo Advanced Perfusion System 1 Electronic Patient Gas System (Catalog #801188) is being recalled due to an intermittent failure in the blender initialization system.

This fault can occur during system startup or during the Electronic Patient Gas System (EPGS) calibration process following the 15-minute warm-up period. When the initialization failure occurs, the control sliders on the Central Control Monitor are disabled, and the gas system can only be controlled using local control knobs on the equipment itself.

Healthcare facilities and operators of this equipment should contact Terumo Cardiovascular Systems Corporation to determine if their system is affected and to obtain repair or replacement instructions.

The recalled product

Product
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Surgical Perfusion Equipment
Hazard
  • initialization-fault
  • control-failure

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)

  • S/N: 01751 UDI: 00886799000588

Distribution

Distribution scope not specified by the agency.

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