Terumo Advanced Perfusion System 1 Recalled for Drive Motor Failure
Terumo CVS is recalling 992 Advanced Perfusion System 1 units due to drive motor failures that trigger alarms. The potential hazards depend on the specific medical application.
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 critical procedures where a motor failure could lead to harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 992 units of the Terumo Advanced Perfusion System 1 Base 100/120V. The recall is due to eight complaints received since September 2008 regarding drive motor failure in the Sarns Centrifugal System. The devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
The affected devices are catalog number 801763 with specific serial numbers ranging from 0011-0335 to 1447-1450. These units were distributed worldwide, including the United States and numerous international markets. A failure of the drive motor triggers error messages and alarms, making the issue easily recognizable by the user.
The potential hazards associated with this defect are dependent on the specific application of the device. Users should check their serial numbers against the recall list 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 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
- 992
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
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.
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