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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:170375

Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1

Official recall number

Z-0809-2019

Evidence summary

Product code
NVZ
Recall status
Open, Classified
Event initiated
January 17, 2019
Root cause
Component design/selection
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-0809-2019

Field note

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