St. Jude Medical is a leading manufacturer of cardiac rhythm management devices, including pacemakers and defibrillators. Their products help manage heart rhythm disorders and improve patient outcomes.
Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough
St. Jude Medical is a well-known company that specializes in cardiac rhythm management devices such as pacemakers and defibrillators. They provide solutions for heart rhythm disorders to enhance patient health and quality of life.
Low risk due to the medical nature of the product and the fact that it is designed for specific medical conditions. The devices are regulated and require proper medical supervision.
Patients with heart rhythm disorders, individuals requiring cardiac monitoring or treatment
Ensure the device is prescribed by a healthcare provider, check for proper medical follow-up, and confirm that the device is functioning correctly.
Ensure that the device was recommended by a doctor for your specific condition.
Regular check-ups with your healthcare provider are essential to monitor the device's performance and your overall health.
Your healthcare provider may perform tests to ensure the device is working as intended.
Yes, St. Jude Medical devices are designed and regulated to be safe for patients with specific heart conditions. They undergo rigorous testing and quality control processes.
Regular check-ups are typically recommended every 6 to 12 months, depending on your specific condition and the device type.
Yes, with proper medical supervision and adherence to the device's guidelines, most patients can lead a normal life with a St. Jude Medical device.
We’ve drafted a message you can send St. Jude Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1530-2021 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-1530-2021 from St. Jude Medical. 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.
