SynCardia Total Artificial Heart System Recalled for Cannula Tears
SynCardia Systems is recalling its Total Artificial Heart System due to reported tears in the cannula caused by wear and tear stress. Approximately 1,732 systems worldwide are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 an FDA Class II recall for a structural defect (cannula tears from wear and tear) in a life-sustaining medical device. No reported hospitalizations or deaths are mentioned in the source, placing this below 'Severe,' but the risk of device failure in a critical cardiac support system justifies a 'High' severity rating.
Plain-English summary
SynCardia Systems LLC is recalling the SynCardia Total Artificial Heart System (70CC model code 500101-001 and 50CC model code 570500-000). Approximately 1,732 systems are affected by this recall.
The recall is due to reported tears in the cannula caused by wear and tear stress.
The affected systems have been distributed worldwide. In the United States, distribution includes Alabama, Arizona, Arkansas, California, Florida, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin. Internationally, systems were distributed to Australia, Austria, Canada, Croatia, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lebanon, Lithuania, Macedonia, Poland, Russia, Saudi Arabia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.
Patients using the affected SynCardia Total Artificial Heart System should consult with their physician regarding the recall. Healthcare providers and patients can contact SynCardia Systems LLC for additional information.
The recalled product
- Product
- SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
- Manufacturer
- SynCardia Systems LLC
- Affected units
- 1,732
Distribution
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