Terumo Perfusion System 1 Recalled for Roller Pump Occlusion Malfunctions
Terumo CVS is recalling 648 Advanced Perfusion System 1 units due to roller pump occlusion malfunctions that could prevent pump use during surgery.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves equipment malfunction requiring backup use, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 648 units of the Terumo Advanced Perfusion System 1 Base 220/240V. The recall is due to reports of various roller pump occlusion malfunctions, including stiff or difficult-to-adjust occlusion, loss of occlusion setting, unequal roller-to-roller occlusion, and inability to adjust the occlusion.
These malfunctions could result in the inability to use the pump, which would require replacement with back-up equipment. The affected devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
The recall covers units with catalog number 801764 and specific serial numbers ranging from 0006-0066 to 1441. The devices were distributed worldwide, including in the United States and numerous other countries. Healthcare facilities should contact Terumo CVS for instructions on replacing the affected equipment.
The recalled product
- Product
- System 1 Base 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 qualified medical professional who
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 648
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 (8)
- catalog number: 801764 and serial numbers: 0006-0066
- 0100-0311
- 0313-0322
- 1001-1027
- 1100-1434
- 1436
- 1440
- and1441.
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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