Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions
Terumo Cardiovascular Systems is recalling 26 units of the Sarns Modular Perfusion System 8000 due to reported malfunctions in power distribution and battery back-up systems.
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 (perfusion system) with reported malfunctions in critical power and battery systems, but the source notes that most issues occurred during setup or maintenance rather than active bypass, and no injuries or deaths are explicitly reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 26 units of the Sarns Modular Perfusion System 8000, base 4 pump, with 100V safety monitor included. The affected units are identified by catalog number 16409 and serial numbers 1001-1026. The recall covers units distributed worldwide, including the United States and numerous international locations.
The recall was initiated after Terumo received multiple reports since 2007 regarding various malfunctions of the power distribution and battery back-up systems. According to the source text, very few of these reports occurred during cardiopulmonary bypass procedures; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance.
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. The device is intended for use by qualified medical professionals experienced in operating this or similar equipment.
The recalled product
- Product
- Perfusion System 8000, base 4 pump, 100V 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, when us
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 26
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: 16409 and serial numbers: 1001-1026
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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