Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 81 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
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 (cardiopulmonary bypass) where malfunctions in the air bubble detection system pose a risk of harm, but the source text does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 81 units of the Sarns Modular Perfusion System 8000 base, 5 pump 100V. The affected units are identified by Catalog Number 16410 and serial numbers 1001-1622. These devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
The recall was initiated after Terumo received several reports over the last three years regarding malfunctions of the Air Bubble Detection System. These malfunctions manifested as over-sensitivity and false alarms, with various root causes identified. The issues occurred in systems that were either excluded from prior corrective actions or in systems where previous fixes did not resolve the problem.
The affected units were distributed worldwide, including the United States and numerous international locations such as Argentina, Brazil, Canada, China, France, Germany, India, Italy, Japan, and the United Kingdom. Healthcare facilities and users of these specific serial numbers should contact Terumo Cardiovascular Systems Corporation for further instructions on corrective actions or replacements.
The recalled product
- Product
- Sarns Modular Perfusion System 8000 base, 5 pump 100V. he 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 used by a qua
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 81
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 16410 and serial number 1001-1622
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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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