Medtronic recalls Versa dual chamber pacemakers (VEDR01) with atrial-sensing that may malfunction due to circuit errors. Affected units were sold globally from March 2017 to 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 Versa dual chamber pacemakers (model VEDR01) that may experience circuit errors when programmed for atrial-sensing. This could affect device function, but the recall does not specify immediate injury risks.
A subset of these pacemakers may develop circuit errors when set to dual chamber mode with atrial-sensing. This could cause device malfunction, but the recall does not specify how this leads to injury.
Patients with Medtronic Versa pacemakers (model VEDR01) who were implanted between March 2017 and January 2019. Those with atrial-sensing programming are most at risk.
Check if your pacemaker has the model number VEDR01 and was implanted between March 2017 and January 2019. The device may have been sold with specific GTIN numbers listed in the recall.
Verify your pacemaker model number is VEDR01 and was implanted between March 2017 and January 2019.
The recall does not state that stopping use is necessary. Patients should check if their device is affected.
The recall does not specify a remedy. Affected patients should contact Medtronic for further instructions.
Check if your model is VEDR01 and was implanted between March 2017 and January 2019.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0811-2019 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0811-2019 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.
