Terumo Sarns Modular Perfusion System 8000 Recalled for Power Malfunctions
Terumo CVS is recalling 466 Sarns Modular Perfusion System 8000 units due to reported power distribution and battery back-up malfunctions.
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 backup systems, but the source notes that most issues occurred during setup or maintenance rather than active bypass, and no specific injuries or deaths are reported in the provided text.
Plain-English summary
Terumo Cardiovascular Systems (Terumo CVS) is recalling 466 units of the Sarns Modular Perfusion System 8000, base 4 pump, with 220V/240V safety monitor included. The recalled devices are identified by catalog number 16405 and serial numbers 1001-1466. The product is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
The recall is being conducted due to multiple reports received since 2007 regarding various malfunctions of the power distribution and battery back-up systems. According to the source, very few of these reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance.
The affected units were distributed worldwide, including in the United States and numerous international locations. Terumo CVS is the recalling firm. The source text does not specify specific consumer actions or contact information for the recall.
The recalled product
- Product
- Perfusion System 8000, base 4 pump, 220V/240V 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, wh
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 466
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: 16405 and serial numbers: 1001-1466
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.
See all 6 products in this recall →Related recalls
Same manufacturer · Terumo Cardiovascular Systems Corporation
See all →- HighCDI OneView System BPM Probe temperature sensor measurement inaccuracy
FDA (Devices) · 2025-07-02
- HighTerumo CDI OneView Monitor Probe May Fail to Display Oxygen Saturation Data
FDA (Devices) · 2025-04-09
- HighCardiovascular Procedure Kits Recalled for Pressure Relief Valve Defect
FDA (Devices) · 2024-04-10
- HighCAPIOX FX25 Oxygenator Recalled for Potential Leaks from Improper Bonding
FDA (Devices) · 2023-04-12
- HighTerumo Recalls CAPIOX NX19 Oxygenator Due to Improper Bonding
FDA (Devices) · 2023-04-12
Same hazard · power malfunction
See all →- HighMasimo Rad-G Pulse Oximeter May Randomly Power Off, Causing Loss of Monitoring
FDA (Devices) · 2024-04-24
- HighTerumo Sarns Modular Perfusion System 8000 Recalled for Monitor Malfunctions
FDA (Devices) · 2012-11-21
- HighTerumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions
FDA (Devices) · 2012-10-31
- HighTerumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions
FDA (Devices) · 2012-10-31
- HighTerumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions
FDA (Devices) · 2012-10-31