Terumo Advanced Perfusion System 1 Central Control Module Recall
Terumo is recalling 648 Central Control Modules for the Advanced Perfusion System 1 due to reports of partial or full functionality loss.
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 used in life-support procedures where loss of function could lead to harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 648 Central Control Modules (CCM) for the Terumo Advanced Perfusion System 1. The recall is due to reports that the CCM may lose partial or full functionality. The affected units are distributed worldwide, including in the United States and numerous international markets.
The malfunctioning CCM may exhibit symptoms such as full or partial loss of display, loss of control functions, inability to distinguish status, alert, or alarm conditions, or inability to operate the touch screen. The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
Healthcare facilities and users should identify affected units by catalog number 801764 and specific serial number ranges. Users should contact Terumo Cardiovascular Systems Corporation for instructions on how to proceed with the recall.
The recalled product
- Product
- Central Control Module for System 1: System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 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…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 648
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 (8)
- Catalog number: 801764 and serial numbers: 0006-0066
- 0100-0311
- 0313- 0322
- 1001-1027
- 1100-1434
- 1436
- 1440
- and 1441.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 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 · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- HighTerumo Advanced Perfusion System 1 Recalled for Roller Pump Malfunctions
FDA (Devices) · 2012-07-18
- ModerateTerumo Perfusion System 1 Recalled for Roller Pump Occlusion Malfunctions
FDA (Devices) · 2012-07-18
- HighTerumo Advanced Perfusion System 1 Recalled for Network Communication Failures
FDA (Devices) · 2012-07-25
- HighTerumo Advanced Perfusion System 1 Recalled for Power Malfunction
FDA (Devices) · 2012-07-25
- ModerateTerumo Advanced Perfusion System 1 Gas Control Recall
FDA (Devices) · 2012-07-18
- HighTerumo Advanced Perfusion System 1 Recalled for Network Power Failures
FDA (Devices) · 2012-07-25