St. Jude Medical is a leading manufacturer of cardiac rhythm management products, including pacemakers, defibrillators, and other cardiac devices.
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 solutions. They produce a range of medical devices such as pacemakers, defibrillators, and other cardiac rhythm management products.
The product is designed for medical use and is not intended for general consumer use. It is a medical device that requires professional installation and monitoring.
Patients with cardiac conditions requiring pacemakers or defibrillators
Check for proper medical certification and ensure the device is installed by a qualified medical professional.
Ensure the device is installed by a qualified medical professional.
Verify the device has the appropriate medical certifications and is within the manufacturer's specifications.
Regularly monitor the device's performance and follow up with your healthcare provider.
St. Jude Medical is a leading manufacturer of cardiac rhythm management products, including pacemakers, defibrillators, and other cardiac devices.
If you have a cardiac condition that requires a pacemaker or defibrillator, your healthcare provider may recommend a St. Jude Medical device.
Regular check-ups with your healthcare provider are recommended to ensure the device is functioning properly.
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-1531-2021 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-1531-2021 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.
