Terumo Advanced Perfusion System Power Manager Board Recall
Terumo is recalling 10 Advanced Perfusion System units due to improperly torqued screws on the Power Manager Board, which may cause electrical shorts.
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 (cardiopulmonary bypass) where a defect (electrical short) poses a risk of harm, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 10 units of the 220/240V AC Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. The recall involves specific serial numbers and spare parts for the Power Manager Board. The units were distributed nationwide and in several foreign countries, including Mexico, Belgium, Canada, India, Indonesia, Singapore, South Korea, and Vietnam.
The recall was initiated because screws on the Power Manager Board were not torqued to specification. It is possible that a screw not properly torqued could go undetected during manufacturing testing and loosen over time. This condition may result in the potential for an electrical short in the system.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 10
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.
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- High
- Severe
Similar recalls
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