Medtronic recalls specific dual chamber pacemaker models (SENIA, DDD) from 2017-2019 with potential circuit errors affecting device function. Affected units include SED01, SEDR01, and SEDRL1 models.
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 (SENIA models) produced between March 2017 and January 2019. These devices may experience circuit errors when programmed for dual chamber mode with atrial-sensing, which could affect their normal operation.
The recalled pacemakers may experience circuit errors when programmed to dual chamber mode with atrial-sensing. This error can affect device functionality, potentially causing the device to malfunction. However, the specific risk to patient health is not clearly described in the recall notice.
Patients with Medtronic dual chamber pacemakers (SENIA models) manufactured between March 2017 and January 2019 are affected. Those with devices programmed for dual chamber mode with atrial-sensing are at higher risk.
Check if your pacemaker is labeled as SENSIA, Dual chamber pacemaker (DDD) with model numbers SED01, SEDR01, or SEDRL1. The devices were distributed worldwide between March 10, 2017 and January 7, 2019.
Identify your pacemaker model number by checking the device label or documentation.
Reach out to Medtronic directly to confirm if your device is affected and get guidance on next steps.
No, only specific dual chamber pacemakers (SENIA models) with model numbers SED01, SEDR01, or SEDRL1 produced between March 2017 and January 2019 are affected.
Contact Medtronic directly to confirm if your device is affected and get guidance on next steps. The recall does not specify a remedy.
The recall does not describe a specific risk of serious injury or death. The hazard is described as a potential circuit error affecting device functionality.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0809-2019 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0809-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
