Terumo Advanced Perfusion System 1 Central Control Module Recall
Terumo is recalling 648 Central Control Modules for the Advanced Perfusion System 1 due to reports of partial or full functionality loss.
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 in life-support procedures where loss of function could lead to harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 648 Central Control Modules (CCM) for the Terumo Advanced Perfusion System 1. The recall is due to reports that the CCM may lose partial or full functionality. The affected units are distributed worldwide, including in the United States and numerous international markets.
The malfunctioning CCM may exhibit symptoms such as full or partial loss of display, loss of control functions, inability to distinguish status, alert, or alarm conditions, or inability to operate the touch screen. The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
Healthcare facilities and users should identify affected units by catalog number 801764 and specific serial number ranges. Users should contact Terumo Cardiovascular Systems Corporation for instructions on how to proceed with the recall.
The recalled product
- Product
- Central Control Module for System 1: 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
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- 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
- 0100-0311
- 0313- 0322
- 1001-1027
- 1100-1434
- 1436
- 1440
- and 1441.
Distribution
Distributed nationwide across the United 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.
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