Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions
Terumo is recalling 81 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in power distribution and battery back-up systems.
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 (perfusion system) with reported malfunctions in critical power systems, but the source text does not report any injuries, illnesses, or deaths, and notes most issues occurred during setup or maintenance rather than active bypass.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 81 units of the Sarns Modular Perfusion System 8000, base 5 pump, with 100V safety monitor included. The affected units are identified by catalog number 16410 and serial numbers 1001-1034 and 1036-1622. These devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
The recall was initiated after Terumo received multiple reports since 2007 regarding various malfunctions of the power distribution and battery back-up systems. The source text notes that very few of these reports occurred during cardiopulmonary bypass, with the majority of malfunctions occurring during set-up or being reported during routine preventative maintenance.
The affected units were distributed worldwide, including in the United States and numerous international locations. Terumo Cardiovascular Systems Corporation is the recalling firm. The source text does not specify the exact corrective actions consumers or medical facilities should take, such as whether to stop using the device or contact the manufacturer for a repair.
The recalled product
- Product
- Perfusion System 8000, base 5 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…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 81
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: 16410 and serial numbers: 1001-1034
- 1036-1622
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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