Medtronic to Recall its Dual Chamber Implantable Pulse Generators (IPGs) in the US

Shots:

• The Class I recall of IPGs with model names Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, Q series, is in response to its software error resulting in loss of pacing, through which patients may experience slow heart beating, LBP including light headedness, fainting, and even death
• On 17 Jan,2019 the US FDA identified it as Class I recall of the device, used for providing pacing support to treat patients with bradycardia
• The recall is initiated for the devices manufactured b/w 10 Mar,2017 to 18 Dec,2018 and marketed b/w 16 Mar,2018 to 7 Jan,2019 resulting in 13,440 devices in the US

Click here to read full press release/ article | Ref : Medtronic | Image: Business Journal