Terumo Advanced Perfusion System 1 Flow Pod Recall for False Alarms
Terumo is recalling 150 Advanced Perfusion System 1 Flow Pods due to a circuit board defect that causes false back flow alarms when tubing is absent.
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. The hazard involves false alarms that do not occur when the device is used as intended (with tubing installed), and no injuries or illnesses are reported, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 150 units of the Terumo Advanced Perfusion System 1 Assembly Flow Pod. The recall is due to a defect in the circuit board voltage settings that can cause the device to trigger false back flow alarms when no tubing is installed in the flow sensor.
The affected units are identified by catalog number 802018 and specific serial numbers ranging from 00032 to 00847. These devices were distributed worldwide and nationwide in the US. The system is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
Terumo's investigation determined that the sensor operates correctly if the tubing is installed. The company received two reports of these false alarms. Users should check their serial numbers against the recall list and contact Terumo for further instructions.
The recalled product
- Product
- Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD 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…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 150
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: 802018 and serial numbers: 00032
- 00042
- 00056
- 00147
- 00623
- 00700-00764
- 00766-00820
- and 00823-00847.
Distribution
Distributed nationwide across the United States.
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