Terumo Advanced Perfusion System 1 Recalled for Power Loss Risk
Terumo is recalling 1,713 Advanced Perfusion System 1 units worldwide due to a risk of losing system power during critical medical procedures.
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 life-support procedures where a loss of power poses a significant risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is implementing field correction activities for the Terumo Advanced Perfusion System 1 (APS). The recall involves 1,713 units of the 100/120V AC system, identified by catalog number 801763 and all serial number units. These devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
The recall is being conducted to address identified causes of the system experiencing a loss of power. The field correction activities, which began in late 2015, involve a phased approach to implement design changes and upgrades to improve the reliability of power switching and battery backup. Additionally, a switch protector is being added to the On/Off power switch to prevent accidental power loss.
The affected units were distributed worldwide, including the United States (nationwide, including DC and all listed states), Mexico, Australia, the United Arab Emirates, Hong Kong, Indonesia, Singapore, Taiwan, Thailand, the Philippines, South Korea, Chile, Vietnam, Malaysia, Belgium, Japan, and Canada. Healthcare facilities and qualified medical professionals using this equipment should contact Terumo Cardiovascular Systems Corporation for instructions on the field correction activities.
The recalled product
- Product
- 100/120V AC, Advanced Perfusion System Platform (APS) 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 by a qualif
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 1,713
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 and All serial number units
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Terumo Cardiovascular Systems Corporation
See all →- HighCDI OneView System BPM Probe temperature sensor measurement inaccuracy
FDA (Devices) · 2025-07-02
- HighTerumo CDI OneView Monitor Probe May Fail to Display Oxygen Saturation Data
FDA (Devices) · 2025-04-09
- HighCardiovascular Procedure Kits Recalled for Pressure Relief Valve Defect
FDA (Devices) · 2024-04-10
- HighTerumo Recalls CAPIOX NX19 Oxygenator Due to Improper Bonding
FDA (Devices) · 2023-04-12
- HighCAPIOX FX25 Oxygenator Recalled for Potential Leaks from Improper Bonding
FDA (Devices) · 2023-04-12
Same hazard · power loss
See all →- HighHumidifier devices recalled because power loss alert sounds under two minutes
FDA (Devices) · 2025-10-22
- HighBD Pyxis Medication Dispensing Devices Labeling Update Addresses Manual Access Risk
FDA (Devices) · 2025-03-05
- HighBronchoscopic system may lose power due to defective component
FDA (Devices) · 2024-12-25
- High2025 Polestar 3 Vehicles High to Low Voltage Converter Damage Recall
NHTSA · 2024-12-18
- HighZ-800 Infusion System Recalled for Battery Depletion Risk
FDA (Devices) · 2024-11-27