Terumo Advanced Perfusion Assembly Pump Guts Recalled for Potential Shaft Failure
Terumo is recalling 11 Advanced Perfusion Assembly Pump Guts units because pump shafts may fail, potentially causing the pump to stop during surgery.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a critical medical device used during surgery that could lead to pump failure, meeting the criteria for a Severe (Score 4) classification due to the risk of significant injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 11 units of the Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805. These medical devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. 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.
The recall is due to a defect where the pump shafts may fail at the location of the thread where a locknut is installed. This 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 have the following serial numbers: 880559, 880560, 882808, 882809, 882810, 882811, 882812, 882813, 885541, 885542, and 885543. Healthcare facilities and users should check their inventory for these specific serial numbers and stop using the affected devices immediately.
The recalled product
- Product
- Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: 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…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 11
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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