Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling Sarns Modular Perfusion System 8000 units 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) with reported malfunctions (false alarms/over-sensitivity) that could impact patient safety, but no specific injuries or deaths are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 1,096 units of the Sarns Modular Perfusion System 8000 base, 5 pump 115V. The affected devices are identified by Catalog Number 16401 and serial numbers PT003, 1001-3001. These systems 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 received several reports over the last three years of malfunctions in 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 nationwide in the United States and in numerous other countries such as Canada, Mexico, Brazil, China, India, and various European and Middle Eastern nations. Healthcare facilities and users of these devices should contact Terumo Cardiovascular Systems Corporation for instructions on how to address the malfunctioning Air Bubble Detection System.
The recalled product
- Product
- Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular Perfusion Systern 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 q
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 1,096
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 (2)
- Catalog Number 16401 and serial number PT003
- 1001-3001
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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