Terumo Sarns Modular Perfusion System 8000 Recalled for Monitor Malfunctions
Terumo CVS is recalling Sarns Modular Perfusion System 8000 units due to reported malfunctions in arterial and cardioplegia monitors, including power issues and inaccurate pressure alarms.
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 with reported malfunctions that could lead to harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems (Terumo CVS) is recalling the Sarns Modular Perfusion System 8000, a medical device used for extracorporeal circulation of blood during arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. The recall involves 1,097 units distributed worldwide, including the United States and numerous international locations.
The recall is being conducted due to multiple reports received since 2007 regarding various malfunctions of the arterial and cardioplegia monitors. These malfunctions are categorized as monitor power malfunctions, an inability to measure pressure, and inaccurate or false pressure alarms. The source text does not specify the number of reported injuries or illnesses associated with these malfunctions.
Healthcare facilities and users of the Sarns Modular Perfusion System 8000 should stop using the affected units and contact Terumo CVS for further instructions. The affected units are identified by catalog number 16401 and serial numbers 1001-1243, 1247-1648, 1650-1821, and 1824-3003.
The recalled product
- Product
- Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 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 u
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 1,097
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 (4)
- catalog number: 16401 serial numbers: 1001-1243
- 1247-1648
- 1650-1821
- and 1824-3003.
Distribution
Part of a larger recall action
This product is one of 6 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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