Terumo Advanced Perfusion System 1 Recall for Module Malfunctions
Terumo is recalling 992 Advanced Perfusion System 1 units due to faulty components in the Occluder and Air Bubble Detection modules.
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 is classified as FDA Class II, and the device is used for critical life-support procedures (cardiopulmonary bypass). While no specific injuries are reported in the text, the risk of harm from malfunctioning perfusion equipment is significant, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 992 units of the Terumo Advanced Perfusion System 1 base 100/120V. This medical device is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. The affected units are distributed worldwide, including in the United States and numerous international markets.
The recall is being conducted due to malfunctions in the Occluder and Air Bubble Detection (ABD) Modules. An investigation determined that a faulty component on the modules' application board caused these failures. The affected units are identified by catalog number 801763 and specific serial number ranges.
Users of the Terumo Advanced Perfusion System 1 should contact Terumo Cardiovascular Systems Corporation for further instructions regarding the recall and corrective actions.
The recalled product
- Product
- System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the oper
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 992
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: 801763 and serial numbers: 0011-0335
- 0337-0610
- 1001-1034
- 1037-1049
- 1100
- 1103-1106
- 1109-1450
- and 1452.
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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