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

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

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

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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