FDA Approves Firmware Fix for St Jude Pacemakers

Implantable Cardiac Pacemakers by Abbott (formerly St. Jude Medical): Safety Communication - Firmware Update to Address Cybersecurity Vulnerabilities

The FDA said that, while there are no known reports of patients being harmed by cybersecurity vulnerabilities, there's still an increased risk that those vulnerabilities could be exploited by an unauthorized user accessing a patient's device.

To view the full article, register now. About 280,000 devices are eligible for the update outside the U.S., Candace Steele Flippin, a spokesperson for Abbott said.

Medical device maker Abbott on Monday announced it is voluntarily recalling some 465,000 pacemakers to install a firmware update to patch cybersecurity vulnerabilities in the devices.

Contact your Abbott representative, or Abbott's customer technical support hotline at 1‐800‐722‐3774 if you have any questions about the firmware update.

There are now no known reports of patient harm for the 465,000 implanted devices in question, according to the FDA. The FDA and Abbott do not recommend the removal and replacement of affected pacemakers and suggest that the risks of cybersecurity be discussed between patients and their providers.

According to the FDA, "the update process will take approximately 3 minutes to complete".




The update is for pacemakers with radio frequency (RF) telemetry capabilities, meaning that they are wirelessly connected by radio waves for recording and transmitting the readings of the devices. During this time, the device will operate in backup mode. and essential, life-sustaining features will remain available.

Doctors will now get a warning should batteries run to dangerously low levels thanks to the new software updates.

Pacemakers that were manufactured beginning August 28, 2017, will come pre-loaded with the new firmware and will not require updating, according to a statement. Based on Abbott's data, there's a 0.161 percent chance the update reloads old firmware due to an incomplete update; a 0.023 percent chance that the update will wipe programmed device settings; a not reported chance of loss of diagnostic data; and a 0.003 percent chance the device becomes bricked.

But as a precaution, Abbott says that pacing dependent patients should be given the update in a facility where temporary pacing and a pacemaker generator are on hand.

While the Muddy Waters/MedSec report highlighted important cybersecurity issues concerning the St. Jude medical devices, the controversial manner in which the research was released - by an investment company - and its financial arrangement with "ethical hacker" MedSec, which found the vulnerabilities, drew criticism from the healthcare industry.

Related news:

Hot News

isis-killer-beheading-video-story-top Kremlin confirms contact with Trump lawyer during 2016 campaign
Aug 31, 2017 - 01:42
Trump's lawyer, Michael Cohen , directly contacted Putin's spokesman, asking for the strongman's help on getting it approved. He later became a government informant upon his conviction years later in a $40 million Mafia stock fraud scheme.

isis-killer-beheading-video-story-top The Hajj in Mecca attracts millions Muslim pilgrims to Saudi Arabia
Aug 31, 2017 - 01:38
The country said more than 1,00,000 security personnel at various spots around Makkah and Madina to protect pilgrims. Mina is located between Mount Arafat and Makkah's Grand Mosque.

isis-killer-beheading-video-story-top Nigeria focused for Cameroon tie - Rohr
Aug 31, 2017 - 01:38
The Super Eagles are expected to have a full house on Tuesday in Uyo ahead of Friday's double header against the reigning African Champions.

isis-killer-beheading-video-story-top Mariners acquire veteran starter Mike Leake from Cardinals
Aug 31, 2017 - 01:38
At 66-67, the M's are now three games out of the final American League wild card spot after dropping four straight. Seattle previously traded for Marco Gonzales, who has been part of the rotation struggles for the Mariners .

isis-killer-beheading-video-story-top United Kingdom said to ask European Union for more Brexit negotiating rounds
Aug 31, 2017 - 01:36
The UK team say that the negotiations timetable is not flexible, while the excessive pressure from the European Union prevents a constructive discussion.

isis-killer-beheading-video-story-top Is new CEO Dara Khosrowshahi's taking over signalling changes at Uber?
Aug 31, 2017 - 01:36
Khosrowshahi , the former CEO of Expedia , will officially take over the new position on Tuesday, CNBC reported . Today, at 10 am PT, if all goes well, absolutely nothing will happen at Uber headquarters in San Francisco .

isis-killer-beheading-video-story-top Second Quarter GDP Upwardly Revised from 2.6% to 3.0%
Aug 31, 2017 - 01:35
While the private sector surged ahead, however, government spending shrank, especially at the state and local level. Early estimates indicate that Harvey has caused $40-billion (U.S.) worth of damage to homes, roads and businesses.

isis-killer-beheading-video-story-top United States conducts missile test off Kauai amid growing tensions with N. Korea
Aug 31, 2017 - 01:24
The previous test in June involved the John Paul Jones firing SM-3 missiles at a ballistic target, and was not successful. The Pacific Missile Range Facility on Kauai launched the target missile late Tuesday.

isis-killer-beheading-video-story-top Trump to begin tax reform blitz in Missouri
Aug 31, 2017 - 01:16
The GOP leaders in Congress seem now to be considering a more modest bill - one that has more in common with George W. McConnell is scheduled to attend next Wednesday morning's White House meeting, according to congressional aides.

isis-killer-beheading-video-story-top Levee Breaks South of Houston "Get Out Now" Tweeted
Aug 30, 2017 - 02:01
More than 17,000 people are seeking refuge in Texas shelters, the American Red Cross said, and the number looks certain to grow. Mr Turner has inisisted that a mass evacuation of millions of people by auto was a greater risk than enduring the storm.

isis-killer-beheading-video-story-top Trump arrives in Texas as two Houston reservoirs overflow
Aug 30, 2017 - 02:01
But officials acknowledge the grim reality that fatalities linked to Harvey could soar once the devastating floodwaters recede. The Harris County Flood Control District expects the following subdivision to be impacted by some degree of flooding.

isis-killer-beheading-video-story-top Thailand 'preparing to receive' those fleeing Myanmar violence
Aug 30, 2017 - 02:00
Members of the Rohingya community are ineligible for citizenship in Myanmar because of a controversial 1982 law. This incident typifies the struggle the Rohingya - one of the most persecuted people groups in the world.

isis-killer-beheading-video-story-top Beyoncé And Drake Lead Prayers For Texas Amid Hurricane Harvey Destruction
Aug 29, 2017 - 00:56
Beyoncé , a Houston native, shared a message of sympathy on Instagram late Sunday evening for those affected. Lady Antebellum also announced it would be donating merch profits to relief efforts.

isis-killer-beheading-video-story-top Spanish King joins defiant Barcelona anti-terror march
Aug 29, 2017 - 00:56
The five occupants of the Audi A3 then jumped out and went on a stabbing spree, killing a woman before being shot dead by police. Madrid accuses Catalan leaders of using last week's attacks to win independence from Spain at the cost of the region's security.

isis-killer-beheading-video-story-top Trump threatens again to tear up NAFTA
Aug 29, 2017 - 00:51
The actual wall would be only about 1,000 miles long, Trump has said, with the rest of the border protected by "natural barriers". The Washington Post's National Political Correspondent James Hohmann wrote the president was in a hard position.