Terumo Advanced Perfusion System 1 Recalled for Network Power Failures
Terumo is recalling 992 Advanced Perfusion System 1 units worldwide due to reports of communications and power failures in the system network.
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 power or communication failures could lead to harm, but the source text does not explicitly report 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 992 units of the Terumo Advanced Perfusion System 1 Base, 100/120V. The recall covers units distributed nationwide in the United States and in numerous countries worldwide, including Argentina, Australia, Canada, Germany, Japan, and the United Kingdom.
The recall was initiated after the manufacturer received reports of issues manifesting as communications or power failures in the system network. Specific symptoms include the appearance of a red X or a question mark symbol on pump or module icons on the Central Control Module (CCM), as well as failures affecting single pumps or modules.
The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. Affected units are identified by catalog number 801763 and specific serial number ranges. Users should contact Terumo Cardiovascular Systems for further instructions on how to proceed with the recall.
The recalled product
- Product
- Terumo Advanced Perfusion System 1 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
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- 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 number: 0011-0335
- 0337-0610
- 1001-1034
- 1037-1049
- 1100
- 1103-1106
- 1109-1445
- and 1447-1450.
Distribution
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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