CentriMag Circulatory Support Console May Shut Down During Power Surge
CentriMag Primary Console units may completely shut down without alarm during power surges above 1.8kV, requiring emergency switch to backup circulatory support.
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: This is a Class II FDA recall of a critical medical device component. The failure mode—complete shutdown without alarm during power surge conditions—creates serious risk to patients dependent on circulatory support. The hazard is conditional, triggered only by specific power surge levels (1.8–2.0kV). Per FDA Class II classification and the rubric criteria for risk-of-harm medical devices, this scores as High severity.
Plain-English summary
Thoratec Switzerland GMBH is recalling the 2nd Generation CentriMag Primary Console, part of the CentriMag Circulatory Support System. Approximately 3,425 consoles have been distributed worldwide, including throughout the United States and to numerous countries internationally.
A component change in the console may cause it to fail to conform to the IEC 61000-4-5 electrical surge standard. When exposed to a power surge above 1.8 kilovolts and up to 2.0 kilovolts, the affected console may shut down completely without triggering an alarm. When this occurs, the pump ceases functioning and the patient must be switched to a backup circulatory support system.
The recalled product
- Product
- 2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, part of the CentriMag Circulatory Support System
- Manufacturer
- Thoratec Switzerland GMBH
- Hazard
- device-shutdown
- power-surge
- no-alarm
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)
- 07640135140726
- 07640135140702
- 07640135140719
- 07640135140856
- 05415067037282
- 07640135140894
- 07640135149019
- 07640135149002
Distribution
Distributed nationwide across the United States.
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