Terumo Sarns Modular Perfusion System 9000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 484 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 involves a high-risk medical device (cardiopulmonary bypass) with reported malfunctions (false alarms/over-sensitivity) that could impact patient safety, but the source text does not explicitly report injuries, deaths, or hospitalizations, nor does it classify the recall as FDA Class I.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 484 units of the Sarns Modular Perfusion System 9000, 115V with color screen. The device is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. The affected units are identified by Catalog Number 164300 and serial number 1006-5462.
The recall was initiated after the company received several reports over the last three years of malfunctions in the Air Bubble Detection System. These malfunctions manifested as various failure modes, including over-sensitivity and false alarms, with various root causes. The issues occurred in systems that were 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 Argentina, Bangladesh, Belgium, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, and the United Kingdom. Healthcare facilities and qualified perfusionists who have used or currently possess these specific units should contact Terumo Cardiovascular Systems for instructions on corrective action.
The recalled product
- Product
- Sarns Modular Perfusion System 9000, 115V 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 perfusionist…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 484
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 164300 and serial number 1006-5462
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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