Terumo Sarns Modular Perfusion System 9000 Recalled for Air Bubble Detection Malfunctions
Terumo Cardiovascular Systems is recalling 286 Sarns Modular Perfusion System 9000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a critical safety feature (Air Bubble Detection) malfunctioning in a life-support device, representing a risk of harm where specific injury reports are not detailed in the source text.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 286 units of the Sarns Modular Perfusion System 9000, 220/240V with color screen. This medical device is indicated for use as a heart-lung system for pumping blood during arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. The recall affects units with Catalog Number 164290 and serial number 1005-5463.
The recall was initiated after the manufacturer 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 affected systems were either excluded from prior corrective actions or involved in subsequent issues.
The recalled 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 this equipment should contact Terumo Cardiovascular Systems for instructions on how to address the defect.
The recalled product
- Product
- Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 286
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 164290 and serial number 1005-5463
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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