Terumo Advanced Perfusion System 1 Gas Control Recall
Terumo is recalling 992 Advanced Perfusion System 1 units due to reported difficulty adjusting the gas flow control knob.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional difficulty (adjustment of a knob) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 992 units of the Terumo Advanced Perfusion System 1 Base, 220/240 V. 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 manufacturer received two complaints regarding the Gas System. Both complaints reported that users experienced difficulty adjusting the System 1 Gas System local flow control knob. The electronic gas blender is responsible for controlling and monitoring gas flow rates and oxygen content in the perfusion circuit.
The affected units were distributed worldwide, including the United States and numerous international markets such as Canada, Germany, Japan, and the United Kingdom. Users of this equipment should contact Terumo Cardiovascular Systems Corporation for further instructions on how to address the issue with the gas flow control knob.
The recalled product
- Product
- Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. 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…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- 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: 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 3 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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