Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions
Terumo Cardiovascular Systems is recalling 1,097 Sarns Modular Perfusion System 8000 units worldwide 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 is classified as FDA Class II and involves a high-risk medical device where malfunctions could lead to harm, but the source notes that most issues occurred during setup or maintenance rather than active procedures, and no specific injuries or deaths are reported in the provided text.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 1,097 units of the Sarns Modular Perfusion System 8000, base 5 pump, with 115V safety monitor included. The affected devices are identified by catalog number 16401 and serial numbers 1001-1243, 1247-1648, 1650-1821, and 1824-3003. 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.
This recall is classified as Class II by the FDA. 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. Users should contact Terumo Cardiovascular Systems for further instructions on the recall.
The recalled product
- Product
- Perfusion System 8000, base 5 pump, 115V 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
- 1,097
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 (4)
- Catalog number: 16401 and serial numbers: 1001-1243
- 1247-1648
- 1650-1821
- and 1824-3003.
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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