Medtronic recalls certain vitatron implantable pulse generators (A, E, G, Q series) that may experience circuit errors when programmed for dual chamber mode with atrial-sensing. Affected devices were distributed between March 2017 and January 2019.
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
Medtronic is recalling specific models of their vitatron implantable pulse generators that could have circuit errors when programmed for dual chamber mode with atrial-sensing. This could affect device functionality, but the recall is for devices distributed between March 2017 and January 2019.
The circuit error occurs when the pacemaker is programmed for dual chamber mode with atrial-sensing. This can affect device functionality but does not cause immediate harm or injury in normal use.
Patients with Medtronic dual chamber pacemakers (Adapta, Versa, Sensia) who received the recalled models between March 2017 and January 2019 are affected. Patients with these devices are most at risk.
Check if your device is an A-series (A30A1, A60A1), E-series (E50A1, E60A1), G-series (G70A1, G70A2), or Q-series (Q50A2, Q70A2, Q80A2) model. The devices were distributed between March 2017 and January 2019.
Identify your device model number and serial number to see if it matches the recalled models listed in the recall notice.
The recall applies only when the device is programmed for dual chamber mode with atrial-sensing. If your device is not in this mode, it is not affected.
The recall does not specify a remedy, so contact Medtronic directly for guidance on next steps.
No, only specific models distributed between March 2017 and January 2019 that are programmed for dual chamber mode with atrial-sensing.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0812-2019 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0812-2019 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
