The Recall Desk
HighFDA (Devices)·Z-2020-2012·Announced 2012-07-25

Terumo Advanced Perfusion System 1 Recalled for Power Malfunction

Terumo is recalling 992 Advanced Perfusion System 1 units due to a power loss error message that may affect system stability during medical procedures.

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 critical medical device used for cardiopulmonary bypass where a power loss could pose a significant risk of 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 992 units of the Terumo Advanced Perfusion System 1 Base, 100/120V. The device is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. The recall covers units with Catalog Number 801763 and specific serial numbers ranging from 0011-0335 to 1447-1450.

The recall was initiated because the system has displayed a Red X error message on multiple module icons, indicating 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 this malfunction, and the company is continuing to investigate to determine the root cause. The potential risks associated with the loss of power are noted in the source text.

The affected units were distributed nationwide in the United States and in numerous international countries, including Argentina, Belgium, Canada, and Germany. Healthcare facilities and qualified medical professionals who use this equipment should stop using the affected units and contact Terumo Cardiovascular Systems Corporation for further instructions on the recall.

The recalled product

Product
System 1 Base, 100/120V. 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 — Cardiovascular / Perfusion
Hazard
Affected units
992

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: 801763 and Serial Numbers: 0011-0335
  • 0337-0610
  • 1001- 1034
  • 1037-1049
  • 1100
  • 1103-1106
  • 1109-1445
  • and 1447-1450.

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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Same hazard · power loss

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