The FDA has sent a warning letter to Abbott Laboratories citing manufacturing flaws in several cardiovascular devices that the company acquired with its purchase of St. Jude Medical in January, according to a Reuters report.
The affected devices, known as implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, help pace slow heart rhythms and slow dangerously fast rhythms.
In its communication, the FDA said Abbott had failed to disclose at least one death associated with one of the devices. The agency also noted that an inspection of the company's facility in Sylmar, California, raised questions about the safety of several implantable defibrillators and the Merlin@home monitor, which allows doctors to care remotely for patients with cardiac devices.
The FDA investigation found that lithium batteries in the devices were draining prematurely and that the company had “underestimated the occurrence of the hazardous situation.”
In its letter, the agency said Abbott repeatedly concluded that the cause of premature depletion “could not be determined” even though the company’s supplier had provided evidence that it was due to lithium deposits, known as lithium cluster bridging.
“We take these matters seriously, continue to make progress on our corrective actions, will closely review FDA's warning letter, and are committed to fully addressing FDA's concerns,” a company spokesman said in an email.
Source: Reuters; April 13, 2017.