The Recall Desk
HighFDA (Devices)·Z-3242-2018·Announced 2018-10-03

Terumo Advanced Perfusion System Recalled for Potential Electrical Short

Terumo is recalling 47 Advanced Perfusion System units because improperly torqued screws may cause an electrical short.

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 with a potential for electrical short, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 47 units of the Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. The recall affects units with Catalog Number 801763 and specific serial numbers listed in the agency record. The products 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, which is the base unit circuit 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 instructions for consumers or healthcare providers on how to handle the recalled units, nor does it report any injuries or illnesses associated with the defect.

The recalled product

Product
Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Cardiopulmonary Bypass
Hazard
Affected units
47

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)

  • 03308

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

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Same hazard · electrical short

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