The Recall Desk
HighFDA (Devices)·Z-1966-2012·Announced 2012-07-18

Terumo Advanced Perfusion System 1 Recalled for Battery Depletion Issues

Terumo is recalling approximately 632 System 1 Base units because the backup battery depletes faster than expected, potentially causing unexpected system shutdowns.

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 medical device where a battery defect could lead to unexpected system shutdown during critical procedures, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling approximately 632 units of the Terumo Advanced Perfusion System 1 Base (220/240V). The recall is due to a defect where the integrated backup battery charge depletes faster than expected during periods of system shutdown. This issue may cause the system to falsely indicate a longer battery life than actually remains, particularly if the unit is not subjected to regular use, such as when serving as a backup system.

The battery depletion issue may result in an unexpected system shutdown. Additionally, prolonged battery depletion may cause permanent damage to the battery. The affected units are distributed worldwide, including in the United States and various international locations. The specific catalog number is 801763, and the affected serial numbers range from 0011-0335, 0337-0610, 1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, and 1447-1450.

Healthcare facilities and users should check their inventory for the affected catalog and serial numbers. If a unit is affected, it should be removed from service and returned to Terumo Cardiovascular Systems Corporation for evaluation or replacement. Users should contact the manufacturer for specific instructions on how to proceed.

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 who
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Cardiopulmonary Bypass
Hazard
Affected units
632

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 in 41 states:

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 · battery defect

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