Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

Medtronic Recalls Implantable Defibrillators

The FDA has issued a Class I recall of a Medtronic defibrillator with a potentially lethal malfunction due to a manufacturing defect.

Medtronic Evera / Image: Medtronic
Medtronic Evera / Image: Medtronic

A recent FDA Medical Device Safety report discussed the recall of two Medtronic devices due to a defect in the manufacturing process. A total of nine CRT-Ds and 12 ICD models were affected and included in the Class I recall issued by the FDA on Monday. Class I is the most serious type of recall and was assigned to these devices because the defect may prevent them from delivering life-saving electrical shock therapies.

The defect “causes an out of specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest,” the agency said. “The delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death.”

Researched List: Blister Machines for Life Sciences
Need a blister machine for life sciences packaging? Our curated list features companies serving pharmaceutical, medical device, nutraceutical, and cosmetic industries. Download to access company names, locations, machine specifications, descriptions, and more.
Download Now
Researched List: Blister Machines for Life Sciences
Break out of the ordinary: see what’s new in life sciences packaging
<strong>At PACK EXPO Las Vegas, you’ll see machinery in action and new tech from 2,300 suppliers, collaborate with experts and explore transformative solutions. Join us in September to experience a breakthrough for life sciences products.</strong>
REGISTER NOW & SAVE!
Break out of the ordinary: see what’s new in life sciences packaging