SynCardia Recalls Freedom Drivers for Potential Drive Mechanism Failure
SynCardia Systems is recalling Freedom Drivers because a component may fail, causing the drive mechanism to stop pumping and resulting in the loss of life-sustaining function.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states that the defect results in the 'loss of life-sustaining function,' which constitutes a known fatality or critical injury risk, meeting the criteria for a Critical (Score 5) severity rating.
Plain-English summary
SynCardia Systems, Inc. is recalling Freedom Drivers, which are components of the SynCardia temporary Total Artificial Heart (TAH-t) System. The recall is due to a specific component of the drive mechanism that may fail.
If this component fails, it may cause the drive mechanism to stop pumping. This failure results in the loss of life-sustaining function for the patient. The Freedom Drivers are indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure and are intended for use in and out of the hospital.
The recall involves 56 drivers, of which 21 are currently in use on patients. The affected units were distributed worldwide, including in the United States (AR, NC, CA, OH, PA, TX, MI, and VA) and in Germany, Turkey, and France. Patients and healthcare providers should contact SynCardia Systems for further instructions regarding the recall and replacement of these devices.
The recalled product
- Product
- Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of…
- Manufacturer
- SynCardia Systems Inc.
- Category
- Medical Device — Cardiovascular
Distribution
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