Terumo Sarns Modular Perfusion System 8000 Recalled for Monitor Malfunctions
Terumo CVS is recalling 312 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 in life-support procedures where monitor malfunctions could lead to harm, but the source text does not explicitly report injuries, hospitalizations, or deaths, nor does it classify the recall as FDA Class I.
Plain-English summary
Terumo Cardiovascular Systems Corporation (Terumo CVS) is recalling 312 units of the Sarns Modular Perfusion System 8000, base 5 pump, which includes a 220V/240V safety monitor. The affected devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
The recall is being conducted 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 are identified by catalog number 16406 and specific serial numbers ranging from 1001-1004, 1007-1055, 1057-1310, 1648, 1649, 1657, 1822, and 1823.
The devices were distributed worldwide, including nationwide in the United States and in numerous international locations such as Argentina, Australia, Brazil, Germany, Japan, and the United Arab Emirates. Users should contact Terumo CVS for further instructions regarding the recall and replacement of affected units.
The recalled product
- Product
- Perfusion System 8000, base 5 pump, 220V/240V 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, w
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 312
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: 16406 serial numbers: 1001-1004
- 1007-1055
- 1057-1310
- 1648
- 1649
- 1657
- 1822
- and 1823.
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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