The Recall Desk
HighFDA (Devices)·Z-2021-2012·Announced 2012-07-25

Terumo Advanced Perfusion System 1 Recalled for Power Fluctuation Errors

Terumo is recalling 648 Advanced Perfusion System 1 units due to a Red X error indicating loss or fluctuation of internal power on one side of the base.

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: The recall involves a high-risk medical device used for cardiopulmonary bypass where a power malfunction could lead to patient harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 648 units of the System 1 Base, 220/240V, part of the Terumo Advanced Perfusion System 1. This medical device is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.

The recall was initiated because the devices displayed a Red X error message on multiple module icons. This error indicates a loss or fluctuation of internal power on one side of the system's base. Terumo's initial investigation determined that there may be more than one cause for the malfunction, and the company is continuing to investigate to determine the root cause.

The affected units were distributed nationwide in the United States and in numerous countries worldwide, including Argentina, Belgium, Canada, and Germany. The specific catalog number is 801764, and the affected serial numbers are 0006-0066, 01 00-0311, 0313-0322, 1001-1027, 1100-1434, 1436, 1440, and 1441. Users should check their device serial numbers and contact Terumo for further instructions.

The recalled product

Product
System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional wh
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Cardiopulmonary Bypass
Hazard
Affected units
648

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 (8)

  • Catalog Number: 801764 and Serial numbers: 0006-0066
  • 01 00-0311
  • 0313-0322
  • 1001-1027
  • 1100-1434
  • 1436
  • 1440
  • and 1441.

Distribution

Distributed nationwide across the United States.

The notice also names 43 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Terumo Cardiovascular Systems Corporation 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 2 products in this recall →

Related recalls

Same manufacturer · Terumo Cardiovascular Systems Corporation

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