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
Ref : Medtronic | Image: Business Journal
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