Terumo Advanced Perfusion System 1 Recalled for Network Communication Failures
Terumo is recalling 648 Advanced Perfusion System 1 units due to reports of communications or 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 in critical surgical procedures where system failure could lead to harm, but the source text does not report any actual 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 units of the Terumo Advanced Perfusion System 1 Base, 220/240V. This medical device is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. The affected units are identified by catalog number 801764 and specific serial number ranges.
The recall was initiated after the company 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 single '?' symbol on a pump or module icon on the Central Control Module (CCM). The source text does not report any illnesses, injuries, or deaths associated with these failures.
The affected units were distributed nationwide in the United States and in numerous countries worldwide, including Argentina, Australia, Canada, Germany, Japan, and the United Kingdom. Healthcare facilities and users should stop using the affected equipment and contact Terumo Cardiovascular Systems Corporation for further instructions.
The recalled product
- Product
- Terumo Advanced Perfusion 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
- 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 number: 0006-0066
- 0100-0311
- 0313-0322
- 1001-1027
- 1100-1434
- 1436
- 1440
- and 1441.
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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