Terumo Advanced Perfusion System 1 Recalled for False Pressure Alarm
Terumo is recalling 1,657 Advanced Perfusion System 1 units because a false high-pressure alarm can stop the pump. The company is updating manuals and issuing labeling addenda.
What this means for you
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. The hazard involves a false alarm that stops the pump, which is a functional defect rather than a direct injury or contamination risk, fitting the criteria for moderate severity.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 1,657 units of the Advanced Perfusion System 1 (Catalog number 801763). These devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. The recall is due to a condition where a false high pressure alarm may display a "999" pressure reading and cause the pump to stop.
The affected units were distributed worldwide, including nationwide in the United States and in countries such as Australia, Canada, Japan, and Mexico. The recall is classified as Class II by the FDA.
Terumo is taking action to update the Operators Manual with specific instructions to respond to this condition and will issue a labeling addendum for current users. If a false high pressure alarm occurs, the pressure display can be cleared and the pump re-started by disconnecting the pressure transducer from the system.
The recalled product
- Product
- 100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusio
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 1,657
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 (1)
- Catalog number: 801763
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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