Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 461 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
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 (heart-lung machine) with reported malfunctions (false alarms/over-sensitivity) that could impact patient safety during critical procedures, but the source does not report specific injuries or deaths, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 461 units of the Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The affected devices are identified by Catalog Number 16405 and serial numbers 1001-1461. These systems are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
The recall was initiated after the manufacturer received several reports over the last three years regarding malfunctions of the Air Bubble Detection System. These malfunctions manifested as over-sensitivity and false alarms, with various root causes identified. The issues occurred in systems that were either excluded from prior corrective actions or in systems where previous fixes did not resolve the problem.
The affected units were distributed worldwide, including the United States and numerous international markets. The source text does not specify the exact actions consumers or medical professionals should take, such as contacting the manufacturer or stopping use, but the recall indicates a need for corrective action regarding the detection system's reliability.
The recalled product
- Product
- Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. 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 used by
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 461
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 number 1001-1461
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.
See all 11 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 · malfunction
See all →- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- ModerateOlympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults
FDA (Devices) · 2026-07-29
- High
- ModeratePhilips Azurion 3M15 Medical Imaging Systems Recalled Due to Software Issue
FDA (Devices) · 2026-06-10
- SevereElectric Start Pressure Washers Recalled for Carbon Monoxide Hazard
CPSC · 2026-05-14