Terumo Advanced Perfusion System 1 Recalled for Battery Depletion Issues
Terumo is recalling approximately 993 Advanced Perfusion System 1 units because the battery may deplete faster than expected during shutdown, potentially causing unexpected system failure.
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 medical device used in critical procedures where an unexpected shutdown poses a risk of harm, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling approximately 993 units of the Terumo Advanced Perfusion System 1 Base (100/120V). The device is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. The recall is due to a defect where the battery charge depletes faster than expected during periods of system shutdown.
The System 1 may falsely indicate a longer battery life than actually remains if the device is not subjected to regular use, such as when it is kept as a backup system. This discrepancy may result in an unexpected system shutdown. Additionally, prolonged battery depletion may cause permanent damage to the battery.
The affected units were distributed worldwide, including in the United States and various international locations. The specific catalog number is 801763, and the affected serial numbers are 0011-0335, 0337-0610, 1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, and 1447-1450. Users should check their serial numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional wh
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 993
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: 801763 and serial numbers: 0011-0335
- 0337-0610
- 1001-1034
- 1037-1049
- 1100
- 1103-1106
- 1109-1445
- and 1447-1450.
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
- HighCAPIOX FX25 Oxygenator Recalled for Potential Leaks from Improper Bonding
FDA (Devices) · 2023-04-12
- HighTerumo Recalls CAPIOX NX19 Oxygenator Due to Improper Bonding
FDA (Devices) · 2023-04-12
Same hazard · unexpected shutdown
See all →- CriticalAnesthesia systems recalled over potential unexpected shutdown on mains power loss
FDA (Devices) · 2025-12-24
- CriticalAnesthesia power management boards recalled over potential unexpected system shutdown
FDA (Devices) · 2025-12-24
- CriticalCarestation 750 anesthesia systems recalled over potential unexpected shutdown
FDA (Devices) · 2025-12-24
- HighIntraoperative ultrasound systems recalled over soldering that can shut them down
FDA (Devices) · 2025-11-05
- SevereVentec VOCSN Ventilators Recalled Due to Incorrect Service Parts
FDA (Devices) · 2025-03-05