Terumo Advanced Perfusion System 1 Recalled for Drive Motor Failure
Terumo CVS is recalling 640 Advanced Perfusion System 1 units worldwide due to drive motor failures in the Sarns Centrifugal System.
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 is classified as FDA Class II. The source text describes potential hazards dependent on application but does not report specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 640 units of the Terumo Advanced Perfusion System 1 Base 220/240V. The recall affects devices with catalog number 801764 and specific serial number ranges. The devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
The recall was initiated after the company received eight complaints since September 2008 regarding drive motor failure in the Sarns Centrifugal System. The source text notes that a failure of the drive motor triggers error messages and alarms, making the issue easily recognizable by the user. The potential hazards are described as dependent on the specific application.
The affected devices were distributed worldwide, including the United States and numerous international locations such as Argentina, Belgium, Canada, and Japan. Users should contact Terumo Cardiovascular Systems Corporation for further instructions regarding the recall.
The recalled product
- Product
- System 1 Base 220/240V 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 qualified medical professional who
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 640
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 (5)
- catalog number: 801764 and serial numbers: 0006-0066
- 0100-0311
- 0313-0322
- 1001-1027
- and 1100-1429.
Distribution
Distributed nationwide across the United States.
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 · mechanical failure
See all →- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28