Terumo Advanced Perfusion System 1 Recalled for Roller Pump Malfunctions
Terumo CVS is recalling 648 units of the Advanced Perfusion System 1 due to roller pump malfunctions that may require replacement with back-up equipment during 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-sustaining procedures where a malfunction could lead to serious 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 recalling 648 units of the Terumo Advanced Perfusion System 1 Base 220/240V. The recall is due to reports of various roller pump malfunctions, including unplanned pump stops or pauses and changes in pump speed. These issues could result in the inability to use the pump, requiring replacement with back-up equipment during cardiopulmonary bypass procedures.
The affected devices are identified by catalog number 801764 and specific serial number ranges. The products were distributed nationwide in the United States and in numerous countries worldwide, including Argentina, Australia, Belgium, Canada, and others.
Qualified medical professionals using this equipment should be aware of the potential for pump malfunction. If a roller pump malfunction occurs, the procedure may require the use of back-up equipment. Users should contact Terumo CVS for further instructions regarding the recall and replacement of affected units.
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
- 648
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: 801764 and serial numbers: 0006-0066
- 0100-0311
- 0313-0322
- 1001-1027
- 1100-1434
- 1436
- 1440
- and 1441.
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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