St. Jude Medical is a leading manufacturer of cardiac rhythm management products, including pacemakers, defibrillators, and other cardiac devices.
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.
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 low-risk product when used as intended by healthcare professionals.
Patients with cardiac conditions who require pacemakers or defibrillators
Ensure the device is properly implanted and functioning as intended by a qualified healthcare professional.
Check with your healthcare provider to confirm the device is functioning correctly.
Follow the manufacturer's instructions for device maintenance and monitoring.
St. Jude Medical is a leading manufacturer of cardiac rhythm management products, including pacemakers and defibrillators.
Your healthcare provider will determine the appropriate frequency for device checks based on your specific condition and device type.
Contact your healthcare provider immediately if you experience symptoms such as pain, dizziness, or unusual device activity.
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-0964-2022 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-0964-2022 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.
