Terumo Recalls Sarns Modular Perfusion System 8000 Due to Monitor Malfunctions
Terumo CVS is recalling 274 Sarns Modular Perfusion System 8000 units due to reported malfunctions in arterial and cardioplegia monitors, including power issues and inaccurate pressure alarms.
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 high-risk medical device used during cardiopulmonary bypass where monitor malfunctions could lead to harm, but the source text does not explicitly report specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 274 units of the Sarns Modular Perfusion System 8000, base 4 pump, with 115V safety monitor included. The affected devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
The recall is due to multiple reports received since 2007 regarding various malfunctions of the arterial and cardioplegia monitors. These malfunctions are categorized as monitor power malfunctions, inability to measure pressure, and inaccurate or false pressure alarms. The affected units have catalog number 16400 and serial numbers 1001-1141, 1143-1274, and 1333.
The devices were distributed worldwide, including nationwide in the United States and in numerous international countries. Users should check their equipment against the provided serial numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 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 u
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 274
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 (3)
- catalog number: 16400 serial numbers: 1001-1141
- 1143-1274
- 1333
Distribution
Part of a larger recall action
This product is one of 6 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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