SynCardia Systems Nailed for MDR Deficiencies

The FDA issued a warning letter to SynCardia Systems over medical device reporting following an inspection at its Tucson, Arizona facility.

The inspection, which was conducted in August, found that the firm failed to report information suggesting a medical device it produced, the Temporary Total Artificial Heart system, possibly contributed to the death of a patient.

The firm did not submit an MDR regarding the death, claiming it relies on its customers to provide patient death reports associated with its devices, which the agency found to be unacceptable.