Terumo Advanced Perfusion System 1 Flow Module Recalled for Display Malfunction
Terumo is recalling 72 Flow Modules for the Advanced Perfusion System 1 because they may fail to display blood flow information or illuminate the LED indicator.
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 medical device used in critical life-support procedures where a display malfunction could lead to a risk of harm, but no injuries or illnesses have been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 72 units of the Terumo Advanced Perfusion System 1 Flow Module. These devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures when used by a qualified perfusionist.
The recall was initiated after Terumo received one report of a flow module not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. Additionally, the tricolor LED on the affected module was not illuminated. The company's investigation determined that the malfunction was caused by an improper component on a circuit board.
The affected units were distributed worldwide, including in the United States, Australia, Singapore, Jordan, Japan, Vietnam, Germany, Russia, Saudi Arabia, Belgium, Mexico, and Canada. Users should identify affected units by checking for Catalog number 802018 and specific serial numbers listed in the official recall notice.
The recalled product
- Product
- Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 72
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 (18)
- Catalog number: 802018 and serial numbers: 00122
- 00132
- 00137
- 00321-00337
- 00339
- 00340
- 00342-00389
- 00391-00439
- 00441
- 00442
- 00444-00455
- 00457
- 00459
- 00460
- 00466
- 00467
- 00475
- and 00488.
Distribution
Distributed nationwide across the United States.
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 · display malfunction
See all →- HighHyundai vehicles instrument panel display software error recall
NHTSA · 2026-01-26
- ModerateMIRA Surgical System software update recall for motion display issue
FDA (Devices) · 2025-06-11
- HighEssenz HLM Heart-Lung Machines May Fail Due to Software Defect
FDA (Devices) · 2024-12-04
- HighMEDLINE Digital Blood Pressure Monitor Recalled Due to Microchip Faults
FDA (Devices) · 2024-10-16
- HighMedline Blood Pressure Monitor Recalled for Microchip Failure and Overheating
FDA (Devices) · 2024-10-16