FDA warning slams St Jude’s “inadequate response” to device failures
St Jude Medical has been hit with a warning letter from the FDA over the medical device manufacturer’s failure to address issues with its implantable defibrillators and at-home monitoring equipment.
The FDA letter confronts both of the separate issues; the manufacturer is accused of not acting upon evidence that the batteries in its defibrillators are defective causing it to short-circuit, even after a number of hospitalisations and the death of one user in 2014. St Jude later recalled 400,000 of the products, yet continued to fit a further seven patients with them afterwards.
“By basing your firm’s risk evaluation on ‘confirmed’ cases and not considering the potential for ‘unconfirmed’ cases to have been shorts, your firm underestimated the occurrence of the hazardous situation,” he FDA’s letter read.
Second, the letter claimed the company had not done enough to prove that cybersecurity issues in its monitoring equipment had been patched with the latest software update before it was launched to the public. St Jude was last year accused by investment research firm Muddy Waters Capital of skipping basic security protections in the devices.
“We have reviewed your response and conclude that it is not adequate,” the letter continued. “You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.”
Since the original date of these issues, St Jude was acquired by Abbott in a $25 million deal back in January this year. Abbott spokesperson Jonathon Hamilton defended the company by stating “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.”
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