Medtronic recalls specific dual chamber pacemaker models (ADD01, ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, ADVDD01) distributed 2017-2019 that may experience circuit errors affecting device function.
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 dual chamber pacemaker models that were distributed between March 2017 and January 2019. These devices may experience circuit errors when programmed for dual chamber mode with atrial sensing, potentially affecting their normal function.
These pacemakers may experience circuit errors when programmed to dual chamber mode with atrial sensing. This error can affect device functionality, but the record does not specify that it causes serious injury or death in normal use conditions.
Patients with Medtronic dual chamber pacemakers (models ADD01 through ADVDD01) manufactured between March 2017 and January 2019 are affected. Patients with these specific models who have them programmed for dual chamber mode with atrial sensing are at most risk.
Check if your pacemaker has a model number starting with ADD01, ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, or ADVDD01. The devices were distributed worldwide between March 2017 and January 2019.
Identify your pacemaker's model number from the list: ADD01, ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, or ADVDD01.
Reach out to Medtronic directly to confirm if your specific model and serial number are affected.
The recall only applies to specific model numbers listed in the record. If your model is not among ADD01 through ADVDD01, you are not affected.
The recall specifies that the circuit error occurs when the device is programmed to dual chamber mode with atrial sensing. You should contact Medtronic to check your device settings.
The record states the hazard may affect device functionality but does not mention serious injury or death. The danger level is low risk.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0806-2019 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0806-2019 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.
