Medtronic recalls specific dual chamber pacemakers (SPDR01/SPDRL1) that may experience circuit errors when programmed for dual chamber mode with atrial-sensing, 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 certain dual chamber pacemakers that may have circuit errors when programmed for dual chamber mode with atrial-sensing. This could affect device functionality, though the risk is not described as causing serious injury in normal use.
These pacemakers may experience circuit errors when programmed to dual chamber mode with atrial-sensing. This error can affect device functionality, but the recall does not specify that it causes serious injury or death in normal use.
Owners of Medtronic dual chamber pacemakers with model numbers SPDR01 or SPDRL1, manufactured between March 2017 and January 2019, are affected. Patients with these devices are most at risk if the device is programmed incorrectly.
Check if your device has model numbers SPDR01 or SPDRL1. The devices were sold between March 2017 and January 2019. All serial numbers are affected.
Identify if your pacemaker has model numbers SPDR01 or SPDRL1.
The recall does not state that you need to stop using the device. The hazard is described as a potential circuit error affecting functionality, not a safety risk in normal use.
The recall does not provide specific action steps beyond checking the model number. You should contact Medtronic for further guidance.
The recall indicates a potential circuit error when programmed incorrectly, but it does not state that the device is unsafe in normal use.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0810-2019 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0810-2019 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.
