Terumo Advanced Perfusion System 1 recalled for air bubble detection malfunctions
Terumo is recalling 648 Advanced Perfusion System 1 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and oversensitivity.
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 is classified as FDA Class II, and the hazard involves a critical safety feature (air bubble detection) in a life-support device where malfunctions could lead to patient harm, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 648 units of the Terumo Advanced Perfusion System 1 (System 1 base 220/240V). The affected devices are identified by Catalog Number 801764 and serial number 0006-1441. These medical devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
The recall was initiated after the company received several reports over the last three years regarding malfunctions of the Air Bubble Detection System. These malfunctions manifested as various failure modes, including oversensitivity and false alarms, with various root causes. The issues occurred in systems that were excluded from prior corrective actions or in systems where previous fixes were insufficient.
The affected units were distributed worldwide, including nationwide in the United States and in numerous international markets such as Canada, the United Kingdom, Germany, France, and Japan. Healthcare facilities and qualified perfusionists who have used or possess these specific units should contact Terumo Cardiovascular Systems Corporation for further instructions on corrective actions.
The recalled product
- Product
- Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only When used by a qualified perfu
- 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 (1)
- Catalog Number 801764 and serial number 0006-1441
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.
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