Terumo Sarns Modular Perfusion System 8000 Recalled for Monitor Malfunctions
Terumo CVS is recalling 466 Sarns Modular Perfusion System 8000 units due to arterial and cardioplegia monitor malfunctions, including power issues and inaccurate pressure alarms.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device used for cardiopulmonary bypass where monitor malfunctions (inaccurate pressure alarms) pose a significant risk of injury or death to patients.
Plain-English summary
Terumo Cardiovascular Systems Corporation (Terumo CVS) is recalling 466 units of the Sarns Modular Perfusion System 8000, base 4 pump, with 220V/240V safety monitor included. The affected units have catalog number 16405 and serial numbers ranging from 1001 to 1466. These devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
The recall is being conducted because Terumo CVS has received multiple reports since 2007 of various malfunctions in the arterial and cardioplegia monitors. These malfunctions include monitor power failures, an inability to measure pressure, and inaccurate or false pressure alarms. The agency has classified this as a Class II recall.
The affected products were distributed worldwide, including nationwide in the United States and in numerous international locations such as Argentina, Australia, Germany, Japan, and the United Arab Emirates. Users of these devices should contact Terumo CVS for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- Perfusion System 8000, base 4 pump, 220V/240V 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, w
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 466
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 (1)
- catalog number: 16405 serial numbers: 1001-1466.
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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