St. Jude Medical Inc said it would recall some of its 400,000 implanted heart devicesdue to risk of premature battery depletion, a condition linkedto two deaths in Europe.
The devices shock dangerously racing heartbeats back totheir normal rhythm or treat heart failure. All the devices,called implantable cardiac defibrillator (ICDs) and cardiac resynchronization therapy defibrillator (CRT-Ds), contain batteries that were manufacturedbefore May 23, 2015, when the company added insulation to reducethe chance of an electrical short circuit.
"There have been two deaths that have been associated withthe loss of defibrillation therapy as a result of prematurebattery depletion," St. Jude's vice president of qualitycontrol, Jeff Fecho, said in an advisory to physicians onTuesday.
The devices were introduced in 2010 and are meant to lastfor seven years or longer, until their batteries are depleted,the company said. They are designed to vibrate at regularintervals once power is diminished, a signal to patients thatthey should visit their doctors for replacements within 90 days.
In addition, a home monitoring unit wirelessly reads the batterylevel and other information and routinely sends details todoctors.
The company said one of the patients died after hisvibration signal indicated low power, but a few days before hisplanned replacement.
The company said the recall is not expected to have amaterial financial impact on the company, although many patientsare expected to visit their doctors and some could request earlyreplacements.
St. Jude said 841 devices had been returned to the companyfor analysis due to premature battery depletion, traced to abuild-up of lithium clusters in the batteries.
Mark Carlson, medical officer of St. Jude, said in aninterview the company's advisory board of physicians hasstrongly recommended that most patients not seek prophylacticreplacements "because the risk associated with replacing thedevices outweighs the low risk of a patient problem occurring."
News of the issue surfaced late on Monday when short-sellingfirm Muddy Waters tweeted a copy of a physician advisory fromSt. Jude, which agreed in April to sell itself for $25 billion USto Abbott Laboratories.
Monitor battery levels at home
The letter said problems with the lithium batteries wererare and could be identified by patients using tools formonitoring battery levels at home.
Patients should seek immediate medical attention as soon asthey get a low-battery alert from the monitoring devices, theU.S. Food and Drug Administration said, in announcing therecall.
"Hospitals should immediately remove any unused devicesaffected by this recall, and contact the manufacturer to receivecorrected devices," the FDA said.
Wedbush Securities analyst Tao Levy said the recall wouldlikely cost St. Jude no more than "a few million dollars"because relatively few patients will need early replacements anddevices now being sold have improved and reliable batteries.
The recall comes as St. Jude is defending itself againstunrelated allegations that its heart devices are riddled withdefects that make them vulnerable to cyber hacks.
Those claims were made by Muddy Waters and research firmMedSec Holdings. St. Jude has denied the allegations and suedboth firms.
The FDA said on Tuesday its investigation into the cybersecurity vulnerabilities of the devices, including theMerlin@Home monitoring system, was continuing.
"Despite the allegations, at this time, the FDA stronglyrecommends that the Merlin@Home device be used to monitor thebattery for these affected devices because the benefits ofcontinued patient monitoring and the life-saving therapy thesedevices provide greatly outweighs any potential cybersecurityvulnerabilities," the FDA said in a statement.
Battery-depletion recalls or advisories have been issued inthe past two years by Boston Scientific Corp andMedtronic Plc, with no visible impact on companybusinesses, according to Barclays analyst Matt Taylor.
Medtronic in November recalled three models of its InSyncIII pacemakers due to battery problems, but overall companypacer sales continued to grow sharply thanks to newer products,Taylor said.
Boston Scientific in September 2014 alerted doctors ofpotential battery-life problems with two ICDs, and recommendedthat patients upgrade their software.St. Jude advised patients to
check its website for detailson which devices were affected by the battery issue.
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