Terumo Advanced Perfusion System 1 Base Recalled for Power Loss
Terumo is recalling 1,713 Advanced Perfusion System 1 bases worldwide to address power loss issues. The recall involves design changes and switch protectors.
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 (cardiopulmonary bypass) where loss of power poses a significant risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Terumo Cardiovascular Systems Corporation is implementing field correction activities for the Base for Terumo Advanced Perfusion System 1, 220/240V. The recall affects 1,713 units distributed worldwide, including the United States, Canada, Mexico, and various countries in Asia, Europe, and the Middle East. 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 to address identified causes of the system experiencing loss of power. Terumo is implementing a phased approach beginning in late 2015, which includes design changes and upgrades to improve the reliability of power switching and battery backup. Additionally, a switch protector will be added to the On/Off power switch to prevent accidental disengagement.
Healthcare facilities and users should contact Terumo Cardiovascular Systems Corporation for instructions on implementing these field correction activities. The affected units are identified by Catalog number 801764 and all serial number units.
The recalled product
- Product
- Base for Terumo Advanced Perfusion System 1, 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 by a…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 1,713
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 All serial number units
Distribution
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.
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