Terumo Advanced Perfusion Assembly Pump Guts Recalled for Potential Shaft Failure
Terumo is recalling 16 Advanced Perfusion Assembly Pump Guts units because the pump shafts may fail, potentially causing the pump to stop during surgery.
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 during surgery where a mechanical failure could lead to a pump stop, posing a risk of harm to the patient, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 16 units of Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798. These devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. The recall is due to a defect where the pump shafts may fail at the location of the thread where a locknut is installed.
The failure is associated with an atypical noise caused by an unsecured shaft end contacting the rotating pulley. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage. The affected units were distributed worldwide, including in the US states of Connecticut, Florida, Louisiana, Massachusetts, Michigan, New York, and Texas, as well as in Hong Kong, India, South Korea, and Taiwan.
Healthcare facilities and users should stop using the affected pump guts immediately and contact Terumo Cardiovascular Systems Corporation for instructions on return or replacement. The specific serial numbers affected are 882298, 882299, 882300, 882752, 882753, 882794, 882795, 882796, 882797, 882798, 882799, 885547, 885548, 885549, 885550, and 885553.
The recalled product
- Product
- Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical prof
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 16
Distribution
Part of a larger recall action
This product is one of 4 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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